Last Assessment

  • Findings from last assessment have been closed

  • Note any ongoing corrections

1-Management Process

1.1 Safety: Employee Perspective

1.1 Basic Safety Standards

  • 1.1.1 Each site should have and employees would be familiar within the facility with Lock Out Tag Out Program - zero energy state followed before working on equipment.

  • 1.1.2 Each site should have and employees would be familiar within the facility with Emergency Action Plans - Site specific emergency procedures.at a minimum this should include, fire emergency and medical emergencies

  • 1.1.4 Each site should have and employees would be familiar with if required within the facility with Confined Space Program - confined spaces defined and labeled.

  • 1.1.5 Each site should have and employees would be familiar with if required within the facility with Electrical Safe Work Practices - Labeling and arc flash.

  • 1.1.6 Each site should have and employees would be familiar within the facility with Personal Protective Equipment Program and Assessment.

  • 1.1.7 Each site should have and employees would be familiar with if required within the facility with Hearing Conservation Program - Noise monitoring and employee hearing test results.

  • 1.1.8 Each site should have a Contractor Safety Program - site specific requirements.

  • 1.1.9 There is a Health & Safety Policy Statement for the facility which is prominently displayed in the site.

1.1.10 Security

  • 1.1.10.1 Site`s security measures are compliant with FM Global Protocol, ensuring that Fitesa`s assets are secure and follows what is indicate in FM Global Fire Protection procedures.

1.1.11 Corporate Safety Standards

  • 1.1.11.1 "Sites follow the established corporate safety standard of Risk Assessment Procedure

  • 1.1.11.2 Sites follow the established corporate safety standard of Walking-working Surfaces.

  • 1.1.11.3 Sites follow the established corporate safety standard of Hazardous Chemicals Management and Communication, including GHS labels.

  • 1.1.11.4 Sites follow the established corporate safety standard of Hand Held Cutting Devices Procedure.

  • 1.1.11.5 Sites follow the established corporate safety standard of Machine Safeguarding.

  • 1.1.11.6 Sites follow the established corporate standards for Classification and Communication of HS&E Incidents.

  • 1.1.11.7 Sites follow the established corporate safety standard of Basic Safety Requirements

  • 1.1.11.8 Sites follow the established corporate safety standard of Safe Operation of Lifting Equipment.

  • 1.1.11.9 Sites follow the established corporate safety standard for Loading Dock Safety

  • 1.1.11.10 There is a location for chemical storage that includes spill prevention and clear guidance to avoid mixture on incompatible materials;

  • 1.1.11.11 There is a list of local requirements that have to be followed by the site and systems in place to assure compliance.

  • 1.1.11.12 There is an established and documented process that assures that forklifts are regularly inspected for basic safety items such as (but not limited to) safety belts, fire extinguishers, lights, brakes, etc..

  • 1.1.11.13 Forklift drivers must be qualified and trained by a certified trainer for the type of forklift he/she will be operating.

  • 1.1.11.14 There is a system in place to ensure ladders are inspected frequently and maintained in safe conditions for use.

  • 1.1.11.15 Where necessary, flammable liquids will be stored in proper cabinets for flammable material in order to be compliant with regulatory standards. No other materials can be stored inside the cabinets designed for flammables.

  • 1.1.11.16 Sites have established procedures for safely operating fork/clamp trucks including speed limit, interaction of fork/clamp trucks and pedestrians, use of horns or other sound warning systems, etc.

1.2 Quality: Customer Perspective

  • 1.2.1 All employees understand the objectives of the Quality program and the role it has on the company gowth. Also, all employess understand the impact their job has on the quality of the product.

  • 1.2.2 There is a quality Policy/Mission Statement for the facility which is prominently displayed in the site and in line with latest revision issued by corporate.

  • 1.2.3 There is a list of he customers currently being supplied by the site.

  • 1.2.4 There is a Recall procedure on the site specifying how to communicate customers and contain any possible hazards to customer and consumer. Procedure must also clearly detail how to handle material returned from custoemrs and what measures are taken to ensure it stays segragated from good product.

1.2.5 Pest Control

  • 1.2.5.1 "The pest control system includes the following:

  • - A documented control procedure.

  • - There are designated system owners for Pest Control Systems.

  • - The system owners are responsible for maintaining documentation and records and ensuring proper execution of system requirements.

  • - Schedules for inspections and treatments including wood boxes and pallets.

  • - Pest control bait stations, traps, and insect electrocuter locations shall be identified on a site map.

  • - Records of the pesticides and control devices used.

  • - Inspection and maintenance records of all control devices with types of pests caught.

  • - Review of inspection data highlighting the risk areas of infestation.

  • - Recommendations for facility improvements to minimize infestation risks and prevent repeat infestations."

  • 1.2.5.2 Light traps with glue paper are preferred over high voltage eletrocuters

  • 1.2.5.3 " When sites use pest control contractors, the site remains responsible for monitoring the work of the contractor and the effectiveness of the pest control.

  • Their reports should include findings, tracking, trending and actions taken for findings and trending."

  • 1.2.5.4 Pest Control Devices and Chemicals

  • 1.2.5.5 Pest control devices are used in a way that does not attract pests into the facility.

  • 1.2.5.6 Pest control devices are protected from damage.

  • 1.2.5.7 Insect attracting bulbs in the traps are replaced at least annually, preferably at the beginning of insect season.

  • 1.2.5.8 Insecticide used for crack and crevice or spot treatment is periodically varied.

  • 1.2.5.9 All pesticides and baits meet regulatory requirements for the intended use. Preventive measures are employed to prevent pesticide and bait contamination of products. SDSs are readily available.

  • 1.2.5.10 Food storage, consumption, and disposal (including gum, hard candy and drinks) are limited to designated eating areas, such as canteens. Designated eating areas should not open directly into production, maintenance, laboratory or warehouse areas. Closed offices may be designated acceptable eating areas.

  • 1.2.5.11 "If fumigation is recommended by pest control contractor, proper steps are taken to protect raw materials, equipment and finished product from contamination by the chemicals used by the pest control contractor. The measures taken to avoid contamination are documented and on record.

  • Pallets cannot be stored outside as they are a home for pests. Items stored outside need to be away from the building so not to create a home for pests. These items need to be cleaned and insect free before they are brought into the building.

  • Insect lights should be mounted 1.5 to 2 meters from the floor for easy inspection. They should be mounted near the building perimeter, not above/near equipment so insects are drawn to the machine."

  • 1.2.5.12 Positive Air Pressure within the facility is desirable. If it is not applicable, a plan to reduce the entrance of pests is documented.

1.2.6 OLA (Organize, Cleaning, Conformance) Management

  • 1.2.6.1 There are designated system owners for OLA (Organize, Cleaning, Conformance). The system owners are responsible for maintaining documentation and records and ensuring proper execution of system requirements.

  • 1.2.6.2 Standardized pictures are posted in the defined areas.

  • 1.2.6.3 Every defined area has a designated owner. All parts of the facility (external and internal) are part of a specific defined area.

  • 1.2.6.4 There is an annual plan for OLA (Organize, Cleaning, Conformance) auditing

  • 1.2.6.5 There is a list of qualified auditors. Auditors are calibrated to ensure minimum discrepancy on audit standards;

  • 1.2.6.6 The auditors are independent, and they cannot audit their own defined areas

  • 1.2.6.7 Each of the plant's defined areas receives a rating/score on one of the standard audit forms every month.

  • 1.2.6.8 All wall and floor markings in Fitesa plants use the same color schemes, according to color standards. All piping (fire systems, water, natural gas, and compressed air) are painted a standard color.

1.2.6.9 OLA - Cleaning

  • 1.2.6.10 All areas in the site have written cleaning procedures that are properly executed and documented according to a scheduling routine.

  • 1.2.6.11 All internal areas are clean, organized and have a neat appearance.

  • 1.2.6.12 All External areas have a neat and clean appearance.

  • 1.2.6.13 Materials and equipment stored within the building are inspected and cleaned to reduce the potential of environmental contaminants.

  • 1.2.6.14 Cleaning equipment is readily available and properly stored. Cleaning equipment is inspected and replaced when old and worn.

  • 1.2.6.15 Cleaning and sanitization agents are reviewed and approved as effective for the intended use. Such chemicals are reviewed through a chemical clearance system to ensure they are safe for use at the particular location. Procedures for use, including verification of removal of cleaning and sanitizing agents, are documented in an SOP.

  • 1.2.6.16 OLA auditors are calibrated once a year and the weights of the audits template are revised to prioritize the points the site needs to improve.

1.2.6.17 OLA - Organization

  • 1.2.6.18 All tools and other equipment are properly stored at point of use and labeled if appropriate.

  • 1.2.6.19 Ancillary equipment is properly maintained, cleaned, and stored away from the main production area to prevent contamination.

  • 1.2.6.20 Designated smoking areas should be isolated from production and cleaned regularly. Smoking areas are only allowed outside of the buildings.

  • 1.2.6.21 Spills are quickly and effectively removed to minimize the risk of further contamination of the premises or product and to comply with any regulatory requirements.

  • 1.2.6.22 Needles, razor blades and similar items are to be kept in designated areas and away from production processes. Used blades, etc., are to be collected in designated boxes.

  • 1.2.6.23 There are no strange materials (maintenance left overs, construction material) inside of the manufacturing or warehouse areas.

  • 1.2.6.24 External areas are free of debris such as maintenance or construction left overs. Areas detonated to waste storage are well identified and organized.

1.2.7 Internal Audits

  • 1.2.7.1 The audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. The Master Plan shall be strictly followed.

  • 1.2.7.2 The audits are effectively implemented and maintained. They will be fully documented, be site-wide, and follow an agreed schedule.

  • 1.2.7.3 Audits at sites handling products regulated by GMP regulations will include evaluation of the compliance of the site’s systems, operations and procedures against each requirement of all GMP regulations applicable to the site’s products. Sites must understand all GMP regulations for countries in which the products are manufactured, distributed or sold and comply with them.

1.2.7.4 Audit Principles

  • 1.2.7.5 "Basic elements of an audit program include:

  • - leadership full involvement

  • - a designated system owner

  • - a qualified team of auditors

  • - an annual plan and schedule including all FMR requirements

  • - documented detailed audit reports listing all deficiencies

  • "

  • 1.2.7.6 The audits shall be analyzed so a comparison audit to audit are possible. Measures shall be developed so that results can be compared, making an assessment of progress possible.

  • 1.2.7.7 A report is written upon conclusion of the assessment. The report clearly describes the findings and which standards they are related to. Also, all findings are classified according to severity.

  • 1.2.7.8 The audit team is trained and certified by a credited institution. All auditors are trained in audit techniques, and the standards to which an audit is conducted. Auditors shall not be assigned to independently audit their own work area. The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. The audit team represents a cross-section of the organization. Qualifying a sufficient number of auditors is important to help to minimize bottle-necks due to resource constraints.

1.2.7.9 Corrective Actions

  • 1.2.7.10 Deficiencies identified by internal or external audits are corrected promptly in a systemic fashion to avoid repeated occurrences. Action plans for corrections are supported with measures that track progress (e.g.% compliance with scheduled audits, % actions completed on time, number of repeat observations and individual Key Element ratings). Action plans are reviewed with leadership to ensure on-going improving effectiveness of the FMR requirements. Action plan from the audit is laid down to be concluded in no more than 8 months after report is received

  • 1.2.7.11 Any defect detected should lead to a corrective or preventive action.

  • 1.2.7.12 Major and Critical observations are investigated to determine root causes. Systemic solutions based on the deficiencies are identified and included on the action plans. Temporary corrective actions may be necessary until permanent solutions can be implemented. Corrective actions are verified to be effective. The action plans include designated owners and a completion date.

  • 1.2.7.13 Repeat findings are noted and highlighted in the audit report. It is important to track the number of repeated observations to assess effectiveness of actions from previous observations.

  • 1.2.7.14 There will be evidence of self-initiated, systemic improvements plans coming from internal observations. Emplyees are recognized by their contributions.

  • 1.2.7.15 Sites will track the completion of all identified corrective actions. The expectation is that the sites will have closed the action plan up to 8 moths after receiving the audit report. It is important to establish the best way of verifying the closing of these actions. A frequent review of a comprehensive summary of actions completed is helpful to avoid having items open for a long time.

  • 1.2.7.16 Lasting solutions based on root cause analysis from quality audits, customer quality incidents, customer complaints, etc. are implemented and verified.

1.2.7.17 Audits Reviews

  • 1.2.7.18 There will be regular and effective tracking of progress (e.g. % items completed, over-due items). Follow-up activities shall include the verification of the actions taken and the reporting of verification results.

  • 1.2.7.19 Results, development of solutions and action plans are reviewed with leadership. The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are completed without undue delay to eliminate detected nonconformities and their causes.

  • 1.2.7.20 Periodically, each Fitesa site is cross-audited by another Fitesa site. All of the FMR requirements shall be implemented. The FMR audit shall include all of the basic FMR requirements.

1.2.8 Committees

  • 1.2.8.1 The site actively participates in the current Fitesa Global Committees such as Quality, HS&E, OLA, Maintenance, Energy, Purchasing, Cost Savings, and Process.

  • 1.2.8.2 Best practices presented in the Fitesa Global Committees are implemented in the site.

1.2.9 DTO

  • 1.2.9.1 The SOP for DTO audit is defined by a written procedure, with a formal annual master plan and schedule. A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.  There is a designated system owner.

  • 1.2.9.2 There is a system to continuously check practical application of operating standards.

  • 1.2.9.3 Critical stages of a process are identified and described into SOPs. Collaborators are trained, then audited against these SOPs. When the audit score is not satisfactory the personnel is re-trained and the month following the end of the training the audit is repeated once again.

  • 1.2.9.4 Collaborators are audited on the basis of a master audit schedule using standard audit forms (SOP Checklist).

  • 1.2.9.5 Operational Work Diagnosis (DTO ) ensure knowledge and hability of collaborators and feedback for the continuous improvement of operating standards.

1.3 Efficiency: Shareholder Perspective

  • 1.3.1 There is an Efficiency Policy for the facility which mirrors global policy and is prominently displayed in the site.

  • 1.3.2

1.4 Sustainability: Community and Ecological Perspective

  • 1.4.1 There is an Sustainability Policy for the facility which is prominently displayed in the site.

  • 1.4.2 Site complies with all Environmental legal requirements

  • 1.4.3 There are programs in place to support employee welfare and improve the relationship with the community where the plant is located.

  • 1.4.4 Air, Water, Storm Water, and Waste Emissions Programs - permit, emissions, monitoring, compliance are all in place according to local regulations

  • 1.4.5 Site should evaluate and record significant environmental aspects and impacts from its processes on a regular basis indicating all control measures deployed.

1.5 Leadership

  • 1.5.1 There is a regular review of site`s performance and strategic planning on critical analysis event (at least once a year). This review includes the analysis influence on internal and external factor (ex. SWOT analysis). This analysis includes there review of the list of all interested parts in the company (Customers and suppliers). As an outcome, there are clear directions on how to address the points discussed.

  • 1.5.2 Site`s top leadership is present and has recorded participation on the critical analysis event (not a representative).

  • 1.5.3 There is management system manual written as controlled document that covers the alignment of the site with corporate values and priorities, as well as a updated org chart of the strategic positions of the site and the responsibilities attributed to each department.

  • 1.5.4 The inputs and outputs (deliverables) of each department/process, as well as its structure, are properly mapped and recorded in a controlled document that is periodically revised. The interactions among the departments are also documented.

  • 1.5.5 Energy consumption is tracked and has clear goals for energy efficiency that demonstrate the drive for continuous improvement.

  • 1.5.6 There is evidences that all corporate policies are clearly communicated with all collaborators of the site. All employees understand how their work is part and how it affects the content described in the policies and understand the consequences of deviation on their work to the site`s Quality and Performance.

  • 1.5.7 A Quality Assurance individual is designated and does not have direct responsibility for manufacturing performance. This assures that the QA individual has authority to make independent decisions. The QA individual has ultimate product release authority and approval of Quality Assurance Systems.

  • 1.5.8 A HSE Assurance individual is designated and does not have direct responsibility for manufacturing performance. This assures that the HSE has authority to make independent decisions.

  • 1.5.9 There is no evidence of presence/consumption of alcohol or any illegal substances found on the premises of the site.

  • 1.5.10 The Site has an Ethics, Equal Opportunity and Grievance Policy.

  • 1.5.11 There is a reward system in place to recognize good quality performance and valuable contribution from plant personnel.

1.6 Compliance

  • 1.6.1 There is a predefined list of regulations the site needs to comply with that fulfill requirements of the business supplied by the site. There is evidence that all of the systems required are in place an functional.;

  • 1.6.2 Site is compliant with local regulations applicable to the markets that the product is sold into;

  • 1.6.3

1.7 Document Control

  • 1.7.1 "A system ensures the content of all specifications and standards are accurate, complete and up-to-date prior to production.

  • The specifications and standards include raw material requirements, testing requirements, standard operating conditions including targets and limits, standard operating procedures, packaging, labeling, and shipping conditions.

  • Technical standards follow the environmental and safety aspects.

  • The system includes a regular specification review process."

  • 1.7.2 " Technical standards authorize these operations (rework, reprocess, reclaim, repair, recycle, resale and blend) before they are conducted.

  • Products produced from these operations (rework, reprocess, reclaim, repair, recycle, resale and blend) are only released if they meet all approved technical standards."

1.7.4 Product Specification

  • 1.7.3 " All finished product is manufactured according to approved specifications. Technical standards supplied externally are accurately translated to internal specifications and standards. "

1.7.5 Document Control System

  • 1.7.4 "There is a Master List of all controlled documents. Internal and external documents (including historical) are securely maintained.

  • "

  • 1.7.5 "There is a procedure to manage the procedures in the site. Document availability, document management process, review and approval process, change process, retention and disposal, document training , the distribution and retrieval process should all be included in an electronic system, if possible. Also, the system should ensure:

  • a) the current revision status of documents are identified,

  • b) the relevant versions of applicable documents are available at points of use,

  • c) the prevention of the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

  • Procedures follow a consistent format, and are available in the local language.

  • Document history is maintained and includes what was changed and date of change.

  • Written procedures are reviewed at least every three years. Out-of-date procedures are either updated or declared obsolete and archived."

  • 1.7.6 Written procedures match actual practice. When procedures require records, the records will be attached or referenced to aid in change control.

  • 1.7.7 Written procedures are required for all areas critical to product quality, customer service, product development, HS&E, and production.

  • 1.7.8 Critical SOP's are identified and used as reference for DTO

  • 1.7.9 There is a system for approving temporary changes to procedures, standards and specifications.

  • 1.7.10 When a procedure is changed, there is an analysis made of the possible impacts on Quality

  • 1.7.11 System records approval date and effective of new documents or document revisions. Effective date is the date when all employees affected by the procedure have been trained.

  • 1.7.12 "List of activities to be documented as procedures in the system (minimum):

  • Document Control, Quality Assurance, Receiving of Raw Materials, Start-up and Shut-down Line Checks, Cleaning, Process Control Strategy, Handling of Out-of Specification Test Results, Product Quality Inspections and Measures, Validation, Training, Finished Product Release, Inspection on Trucks, Product Retrieval, Self Improvement Program, Pest Control Program, Maintenance, Storage of Records, Quality Incidents, Customer Complaints.

  • "

1.8 Budget

1.9 Goal Deployment and Follow-Up

2-Order and Planning

2.1 Order handling

  • 2.1.1 "There is a procedure in place describing how to handle the orders coming from the customers. System includes:

  • - Workflow with the steps the order goes through before going to production;

  • -Who has responsibility for each of the steps;

  • -Time expectations from receiving the order and sending back the delivery expectation to the customer."

2.2 Block planning

  • 2.2.1 There is a process in place to schedule the line according to the similarity of products to optimize line efficiency. (ex. Colors, Resins, Product structure, Additives, etc...)

  • 2.2.2 Limits and restrictions are in place to describe minimum lots of production per technology, color, resin, etc... These limits are agreed with operations and deviations are properly authorized before making into the schedule.

2.3 Fine Planning

  • 2.3.1 Final version of the production schedule is available to operations either online through ERP or other computer system or as a controlled copy with a system to ensure that only the most updated version is distributed

  • 2.3.2 Operations adhere to the production schedule. Deviations have a pre stablished approval flow and are documented.

2.4 Raw Material

  • 2.4.1 All raw materials, packaging and auxiliary materials are purchased following a written specification with supplier agreement to comply. Supplier agreements are documented and updated with each change to the specification. There is an internal spec for each raw material.

  • 2.4.2 There are written procedures in place detailing the requirements to receive, release, block and reject raw materials. The quality of the materials is verified before being released for use. Records provide evidence that procedures are being followed. Quality Assurance and/or Health Safety & Environment is responsible for the release of any material, depending on the use of the material .

  • 2.4.3 " Incoming shipments are visually inspected for trailer and material condition. Proof of these inspections is documented. Trailers and containers should be tamper proof or sealed, if possible. Seal integrity is verified as part of acceptance. Delivery vehicles are unloaded at defined locations, designed for the purpose.

  • Trailers, containers, materials, or pallets, which are damaged or do not meet specified requirements are not accepted.

  • Containers may not be re-used unless cleaned prior to re-use.

  • The locations are designed to protect material from environmental damage during unloading and prevent mix-up."

  • 2.4.4 All materials are checked to ensure identity including unique lot number and compliance with documented specifications for material acceptance. Acceptance criteria should be based on historical performance of the supplier and materials. Acceptance criteria may include any or all of the following: label identification, COA acceptance, in-house testing, and independent verification of COA results.

  • 2.4.5 If raw material acceptance testing is conducted, test samples must be representative, contamination free, traceable, labeled, results recorded, and fully compliant with specifications.

  • 2.4.6 Materials received are clean, undamaged and clearly identified with labels (or attached documentation) showing the material reference code.

  • 2.4.7 Procedures used to control the quality of material samples for acceptance testing : Sampling is done in an environment and using tools and procedures to prevent contamination of the samples; samples are traceable back to the individual deliveries or container of samples; sample labels show the material name, lot or control number, sample location, date and name of person collecting the sample; test procedures provide supporting evidence that the samples were properly identified, not contaminated and are fully compliant with specifications.

  • 2.4.8 A positive release system is in place for materials to ensure proper sampling, testing (if applicable) and release before use.

  • 2.4.9 Materials are used on a first in first out (FIFO) basis. Partially used materials are protected from contamination/damage and used first at the next opportunity. Material status is controlled to avoid improper use. Control may be achieved through physical separation, labeling, or use of a validated computer system. Materials with different release statuses are physically separated. Obsolete and expired raw materials and packaging materials are disposed of to minimize the risk of contamination, inadvertent use, and misuse.

  • 2.4.10 All materials are stored in a manner to prevent contamination and degradation. Materials are covered when there is a risk of contamination. If materials become contaminated, they are immediately blocked to avoid inadvertent use.

  • 2.4.11 Different materials are not stored on the same pallet unless physically separated (such as in separate containers, each labeled) and adequate to prevent mix-ups and cross contamination.

  • 2.4.12 There must be a system to track lot numbers for critical materials, including bulk materials. Material lot identity must be maintained throughout the manufacturing process so that finished product can be traced back to the raw material lot consumed.

  • 2.4.13 In-process materials, such as batches of latex or surfactant, recycled polymer, and process aids must have specifications and quality controls. Systems are in place to ensure materials produced or processed internally consistently meet specifications and production standards.

  • 2.4.14 Unloading hoses are stored off of the floor, capped and where required drained and dried. Hoses are of minimum length to prevent material degradation and facilitate cleaning. Unloading systems are properly identified to prevent mix-ups and properly controlled to prevent unauthorized transfer of materials. Where required, hoses should be cleaned after use and sanitized before use.

  • 2.4.15 A system is in place to control the purchase, storage and use of process aids.

2.5 Volume forecasting

  • 2.5.1 There is a process in place to describe how the volume forecast inputs are used to manage the pipeline of raw materials. The process take s in consideration how long the pipe line is and the expiration dates of the raw materials to ensure that materials will not become expired while stored in Fitesa.

2.6 Technical customer service

  • 2.6.1 The site is supported by a technical oriented resource (not necessarily from the site) that is focused in understanding the customer`s processes and the performance of the Fitesa material. Offering new solutions and feeding the process team from the plant with information.

2.7 Operations with Third party converters

  • 2.7.1 All third party converters are audited by Fitesa to ensure they are capable to deliver quality standards aligned with expectations.

  • 2.7.2 Action plans are in place to cover audit findings at converter as well as QA complains.

2.8 Raw Material Demand Planning

  • 2.8.1 There is a established process to plan raw material supply that includes safety inventory levels.

  • 2.8.2 There is contracted volumes with the main suppliers of resin, surfactant, additive and masterbatch to assure there is enough material available to fulfill the site`s operational demands and QA demands.

  • 2.8.3 When possible, there is more than one supplier for critical raw materials.

  • 2.8.4 A back up plan is established in case of rupture of the supply chain from regular suppliers

2.9 Accounts receivable

2.10 Customer relations

2.11 Price List

3-Manufacturing

3.1 Production Line

  • 3.1.1 Technical, Safety and Regulatory standards are approved and in place to define relevant requirements. This covers both written and physical standards.

  • 3.1.2 "While making the finished product:

  • - Materials used in the process are controlled and documented.

  • - Operations comply with the technical standards, regulations, written procedures and validated conditions.

  • - There are procedures in place to handle deviations in the making process.

  • - Actions including deviations are documented and verified.

  • - Centerlines are followed to ensure that the intended finished product design/performance is met.

  • - Analytical, micro and retained samples (where required ) are taken and tested as specified in technical standards.

  • - Process control strategies are being used (e.g. machine controls, procedures, maintenance)."

  • 3.1.3 Where applicable, devices or systems to avoid human error are in place.

  • 3.1.4 "The organization shall plan and carry out production and service provisions under controlled conditions. Controlled conditions shall include, as applicable,

  • a) the availability of information that describes the characteristics of the product,

  • b) the availability of work instructions, as necessary,

  • c) the use of suitable equipment,

  • d) the availability and use of monitoring and measuring equipment,

  • e) the implementation of monitoring and measurement, and

  • f) the implementation of product release, delivery and post-delivery activities.

  • Materials, intermediates and product are not used for purposes other than their approved usage.

  • g) all contractors know and agree to the internal rules."

  • 3.1.5 Manufacture of product must follow approved standards, procedures and specifications. Process and product aims are established and followed to ensure that the intended finished product design/performance is met. A process control strategy is followed. The process control plan specifies the actions to be taken if there are process deviations during processing or if the product fails to meet specifications.

  • 3.1.6 Manufacturing lots are defined to help manage the risk of producing off quality material. A lot is not recommended to be more than 24 hours.

  • 3.1.7 When applicable, proper conditions (e.g. temperature, humidity, microbial, and dust control systems) are defined, maintained, and monitored in the manufacturing environment.

  • 3.1.8 Operator standards (e.g. hygiene, attire, jewelry, pockets, tools, health, etc.) are appropriate for QA/GMP and HSE requirements for the products being produced. Where required by regulation, regular medical examination must be conducted for all production personnel involved with manufacturing processes.

  • 3.1.9 Every produced unit is marked with a unique code. Full traceability is maintained between a unit produced and raw material batch used and vice versa.

  • 3.1.10 Test product should be identified to prevent mix-ups.

  • 3.1.11 Packaging materials and products are not used for purposes other than their approved usage.

  • 3.1.12 There must be a system to ensure that a customer’s packaging and labeling requirements are documented and implemented.

  • 3.1.13 Labeling information must be secure, with change controls in place.

  • 3.1.14 Packaging must be properly sized to fit the product, specifically headers, end caps, cartons, bags, etc.

  • 3.1.15 Packaging must protect the fabric against any contamination. Stretch wrap must not have trailing tails.

  • 3.1.16 Equipment cleaning and required sanitization is performed according to plan to prevent product contamination. There should be records.

  • 3.1.17 Production equipment has written, validated cleaning and sanitization procedures, detailing the concentration of cleaning and sanitization agents, method and duration of application and frequency of application. Equipment must be cleaned before sanitization.

  • 3.1.18 Equipment is clean and no risk of product contamination is found.

  • 3.1.19 Where the product comes in contact with the equipment, equipment is cleaned or sanitized at a required frequency before use.

  • 3.1.20 Cleaning and sanitization agents are reviewed and approved as effective for the intended use and compatible with the equipment, surfaces and product to be cleaned. Such chemicals are reviewed through a chemical clearance system to ensure they are safe for use at the particular location.

  • 3.1.21 Hazard areas have to be marked and signage , safety guards and PPE using is mandatory

  • 3.1.22 " Sanitizers should be rotated as necessary to prevent microbiological adaptation and are used in FIFO order.

  • "

  • 3.1.23 Where water can collect inside of hoses or on cleaning equipment, the equipment must be completely dried before storage.

  • 3.1.24 "Utensils and cleaning implements such as scrapers and brushes are approved for product contact; tissues and cloths used for sanitization are lint-free. Dirty or damaged utensils, tissues or cloths are discarded, cleaned or repaired. There is a system to clearly distinguish them from non-product-contact utensils.

  • "

  • 3.1.25 There are designated system owners for Sanitization. The system owners are responsible for maintaining documentation and records and ensuring proper execution of system requirements.

3.2 Transportation to warehouse

  • 3.2.1 There is an established check list to verify that the fork lifts are properly clean to avoid contamination and in good conditions to transport the rolls without damaging the packaging.

3.3 Product Release

3.3.1 Procedure

  • 3.3.1.1 There is a written procedure for releasing intermediate and finished product for shipment which meets the specifications

3.3.2 Release

  • 3.3.2.1 The positive release system must include a review and disposition of material produced outside normal process conditions.

  • 3.3.2.2 Trial product must have defined release criteria, be carefully controlled, identified, and released appropriately.

  • 3.3.2.3 Inventory control systems (computer based or manual) are capable of preventing the accidental shipment of unreleased or off-standard product and intermediates.

  • 3.3.2.4 There is a written procedure for managing suspect or on hold product. This material should be labeled and segregated. The release authority on the QA department and process shall also be specified.

  • 3.3.2.5 Records indicate the person(s) authorizing release of product for delivery to the customer

  • 3.3.2.6 Visual inspection reports are part of the product release. There are clear rejection criteria established.

  • 3.3.2.7 Product returned as part of a retrieval is clearly identified and physically isolated from normal stock.

3.4 Offline recycling

  • 3.4.1 "Recycled material must be produced with:

  • a) control of input

  • b) process control

  • c) test plan based on historical results

  • d) identification "

  • 3.4.2 "Technical standards authorize these operations (rework, reprocess, reclaim, repair, recycle, resale and blend) before they are conducted

  • Reworked and reclaimed products must meet original standards before material release. "

  • 3.4.3 Customer safety clearance is verified before use of the material to ensure that composition does not contain unreleased materials

  • 3.4.5 Procedure clearly states the blends of reclaims that are produced on the site and in which products each blend can be used in.

3.5 Media/Power/Building

  • 3.5.1 Material flow is designed to prevent material mix-ups and cross contamination.

  • 3.5.2 Traffic patterns for personnel and materials are designed to control entry to production operations, lab testing and other sensitive areas and for safety in areas of high powered industrial truck traffic.

  • 3.5.3 Safety Equipment (i.e. Fires extinguishers, Hydrants, eyewash stations, etc..) are properly located, protected, accessible and are regularly inspected.

  • 3.5.4 Premises provide sufficient space to allow manufacturing and storage areas to be effectively separated from administrative, laboratory, locker rooms and cafeteria.

  • 3.5.5 Buildings are designed and maintained to prevent exterior elements from entering through leaking roofs, holes in walls or poorly fitting doors and windows. Any openings through outside walls, such as pipe entries, cracks, and crevices, are effectively sealed.

  • 3.5.6 Walls, roofs, ceilings, and equipment are kept free from leaks and chipped or peeling paint.

  • 3.5.7 Grounds and roadways are properly maintained to prevent standing water.

  • 3.5.8 All surfaces are easily cleanable; wooden surfaces are avoided unless sealed. Interior walls are non-dusting (surface does not attract or hold dust) and cleanable. Ceilings are free of clutter and debris and consideration is given to cleaning. Space is provided around and beneath equipment to allow efficient operation, maintenance, housekeeping, cleaning and sanitization.

  • 3.5.9 Drains are covered and they include traps and vents.

  • 3.5.10 Floors, walls, and ceilings of production and storage areas are constructed in order to be resistant to cracking and chipping.

  • 3.5.11 Vegetation does not grow next to or over the walls of buildings used for production or storage. A 1 meter (36 inches) border of crushed rock or pavement around the outside of buildings helps control pests, discouraging a pest harborage. Materials are stored at least 0.5 meter (18 inches) from internal and exterior walls.

  • 3.5.12 Insect screens protect windows and doors that are left open. Exterior doors are not left open, unless protected with screens. Mesh must avoid entrance of insects and not allow accumulation of dust on it.

  • 3.5.13 Dock doors are designed to prevent pest entry into the building, such as with dock seals or canopies, specially in entrances that take from opeations directly to the outside.

  • 3.5.14 Eating and break areas, designated and isolated from production, laboratories, and storage. In case these areas are located inside, they must be well located and defined and need to have at least two doors separating from manufacturing and warehouse areas. Garbage containers must be closed and must be emptied on a daily basis.

  • 3.5.15 The facility has adequate washing and toilet facilities that are easily accessible to manufacturing. Toilet facilities are separated from production, lab, and storage areas. These facilities include running water, soap or detergent, single service towels or hot air dryers, and hand wash signs.

  • 3.5.16 Lighting is sufficient for safe operations. Lighting fixtures in production and storage areas are shielded or have shatterproof bulbs. Insect attracting lighting is not closer than 3 meters to the production and storage entrances.

  • 3.5.17 Where required, there are deliberate methods to minimize airborne contamination (dust, dirt, or even insects) from passing into production areas. Examples include: positive air pressure in manufacturing areas, air curtains and double airlock doors separating production from other areas.

  • 3.5.18 Ventilation and portable fans do not blow onto manufacturing equipment or unprotected product.

  • 3.5.19 Buildings are equipped with escape and rescue routes that are clearly labeled and unobstructed .

  • 3.5.20 Where the nature of the work can be impacted by the surroundings, (laboratories, sensory test areas, and data centers), facility and equipment design includes defined segregation/isolation measures, proven to minimize the effect of the surroundings on the work.

  • 3.5.21 Where environmental control is necessary to maintain product quality and test integrity, environmental conditions are monitored and recorded.

  • 3.5.22 There is adequate and segregated storage for raw materials, packaging materials, cleaning equipment, bulk product, finished product, test samples, product returns, and rejected material.

  • 3.5.23 Space and equipment are provided for cleaning, sanitization and storage of auxiliary containers, tools, hoses, and mobile equipment.

  • 3.5.24 Unloading areas for bulk deliveries of raw materials and process tanks are designated and controlled to minimize the possibility of miss-pumping. Transfer lines are stored off the floor, capped, labeled, and preferably of different sizes to minimize mix-ups.

  • 3.5.25 Water, used as an ingredient, must be routinely sampled and tested from all outlet points if there is a microbiological requirement. Water is tested for microbial content and chemical analysis and the results documented.

  • 3.5.26 When being used as an ingredient in the product formulation, water should not be stored for more than 24 hours unless it is continually circulated through microbial treatment systems.

  • 3.5.27 Compressed air, nitrogen or other gases that may be used in the process must be free from contaminants such as water, oil, and unwanted gases and microbes.

3.6 Production followup systems

  • 3.6.1 There is a system in place to acquire accurate operational data (uptime, scrap, reclaim, etc...) and create a database to be sued by the operations team to look for opportunities of improvement and to help investigate possible deviations.

3.7 Process Control

  • 3.7.1 A valid master list is maintained of all specifications that have been issued.

3.7.2 Process Control Strategy and Execution

  • 3.7.3 The process control strategy is defined and is compliant with corporate standard. Included in the strategy is when adjustments should be made, who can make adjustments, and the allowable range of adjustments. The process control strategy is statistically based (e.g. with control charts or CUSUM).

  • 3.7.4 There are statistically based control limits for key properties of products. These are monitored by the lab and there is a system established to warn operations in case product is running out of the control limits.

  • 3.7.5 Control limits are tighter than customer spec,

  • 3.7.6 Changes to the Process Control are managed through the Change Control system.

  • 3.7.7 Operating personnel are trained to understand process control parameters and their relationship to finished product quality, what to monitor, and when and how to investigate abnormal variation.

3.7.9 Process Control Standards

  • 3.7.9 Standards are clear and easy to understand for training and actual use. Standards include packaging, warehousing, storage, handling, loading and shipping requirements.

  • 3.7.10 Instructions include process set-up conditions, process control strategies, targets and limits for process control conditions and quality acceptance criteria.

  • 3.7.11 Critical process standards are defined for parameters to be controlled. These are controlled and have proper release records.

  • 3.7.12 "There is a trial plan process that is used whenever operating outside normal process standards.

  • Plans include the purpose of the trial, safety clearances, experimental plan, material requirements (raw materials, finished product disposition, and labeling), special testing required, approvals and a summary of results."

  • 3.7.13 Process capabilities must meet specification requirements, and they shall be continuously improved.

  • 3.7.14 Production process and quality data are recorded and monitored on a routine basis to identify overall quality levels and trends. Improvement opportunities are identified.

3.8 Internal transportation

  • 3.8.1 Traffic aisles are marked and kept clear.

  • 3.8.2 Exhaust gases such as NOx from internal combustion engines can degrade nonwoven products. Use of electric fork trucks is preferred, however propane trucks protected with three-way catalytic converters with airflow controllers, are acceptable.

  • 3.8.3 Forklifts and clamps are maintained clean to avoid possible contamination. Inspection of these are kept as a record.

  • 3.8.4 Forklift maintenance records are available. Inspections are in place to detect safety issues.

3.9 Testing of material

3.9.1 Sampling Instructions

  • 3.9.1.1 Sampling instructions and plans are documented. Sampling plans are based on valid statistical and scientific rationale to ensure adequacy for intended use and consistent with demonstrated capability of the process acording to corporate strategy.

3.9.2 Methods

  • 3.9.2.1 Industry standard test methods will be used. Documentation must be available confirming the capability to successfully practice this method.

  • 3.9.2.2 All methods are appropriate for the designated use with sufficient accuracy and precision.

  • 3.9.2.3 Quality acceptance criteria for defect classification and physical standards are controlled, clearly defined, approved and available for use. Grading systems are fully described and are compliant to corporate standard.

  • 3.9.2.4 If a customer requests the use of a non-industry method, sufficient training and qualification will be provided by the customer to assure that the method can be performed successfully. A co-op test between the customer’s lab and Fitesa's lab may be needed for this confirmation.

  • 3.9.2.5 Validated procedures should be in place covering all key laboratory operations. Current approved analytical methods and procedures must be readily available and followed prior to manufacture. Superseded test procedures are archived over the life of the product.

  • 3.9.2.6 Test equipment is appropriately used as recommended by the relevant standard test procedure (ASTM, WSP, EDANA,etc.).

  • 3.9.2.7 Prepared solutions are made per procedure. Standard samples and solutions are clearly identified with contents, date of preparation, name of person who prepared the standard, appropriate reference and expiration date.

  • 3.9.2.8 Safety data is included in all chemicals labels.

  • 3.9.2.9 The determination and control of expiration dates is outlined in a written procedure (or follow the manufacturers' recommendations) and regular checks are carried out to ensure that no expired materials are in use.

  • 3.9.2.10 Sensory testing includes softness, smell. All sensory testing must be described in an approved procedure. Sensory standards are stored under conditions that minimize degradation.

  • 3.9.2.11 Reference standards must be available, approved, and protected.

  • 3.9.2.12 The laboratory has a written procedure for handling out-of-specification results including documentation requirements.

  • 3.9.2.13 Retesting is acceptable when the investigation indicates that analyst error caused the out-of-specification result or when the review is inconclusive. Retesting/resampling is only permitted as defined in the approved procedures/standards.

3.9.3 Records

  • 3.9.3.1 " The minimum information recorded as part of lab records includes:

  • - Sample identification number or name.

  • - Batch number and where needed, the manufacturer and/or supplier.

  • - Reference to the relevant specifications and methods.

  • - Test results including observations and calculations and a copy of any relevant certificates of analysis.

  • - Dates of testing and the identity of the analyst and where required, the identity of the person verifying the testing and calculations.

  • - Identification of the specific pieces of equipment used.

  • - Where labs are responsible to determine specification conformance, clarity on whether the material or product met specifications."

  • 3.9.3.2 Laboratory results are recorded as work is conducted and the records retained.

  • 3.9.3.3 Analytical and microbiological test results are documented (in permanent ink when written by hand), together with a reference to the method, relevant calculations and the original data from laboratory equipment, such as printouts.

3.9.4 Calibration and Equipment Maintenance

  • 3.9.4.1 There is a calibration procedure for all key laboratory equipment. The procedure details the calibration frequency, responsibility, specific limits, and standards to be used and requires that equipment outside of acceptable limits be temporarily taken out of operation, serviced, and recalibrated before being used again.

  • 3.9.4.2 Standards used for calibration (e.g. weights, measures, thermometers) are traceable to the recognized reference standard (e.g. national, international).

  • 3.9.4.3 Actual calibration results and actions taken if the calibration fails should be documented in calibration logs.

  • 3.9.4.4 Instruments and equipment are tagged by a visible indication showing when last calibrated, and when next calibration is due. Calibration must be done on the working range of the equipment.

  • 3.9.4.5 The maintenance and cleaning schedule for all key laboratory equipment must be determined. There must be documentation for each piece of equipment showing all maintenance, repairs and replacements.

  • 3.9.4.6 The cleaning and storage of equipment (including glassware) is controlled by written procedures.

3.9.5 Training

  • 3.9.5.1 There is initial training to qualify analysts, refresher training, and statistical verification, such as gage R&R. Evaluation of the suitability of the analyst to perform sensory testing is required. These should be documented.

  • 3.9.5.2 Personnel that perform analytical, microbiological and sensory functions possess the technical mastery (education and/or experience) needed to assure that quality results and capability of the people are maintained.

3.9.6 Accurate and Reliable Results

  • 3.9.6.1 There should be an ongoing program to verify the accuracy (calibrations and lab co-ops) and precision (Gage R&R) of data provided by the laboratory. Gauge R&R has to performed at a maximum of two years period or when new member join the qualified testing team. Plans are developed to address unacceptable study results.

  • 3.9.6.2 Laboratories must meet environmental requirements as defined in tests, usually temperature and humidity. If controls are not available, then at a minimum these parameters should be monitored.

  • 3.9.6.3 All acceptance and release data and documented decisions are managed and controlled.

  • 3.9.6.4 Laboratories must have the most up-to-date versions of customer specifications and product specifications. If specifications are rewritten for internal use, there must be a direct link to the associated customer specification and rigorous control of the distribution of the internal document.

3.10 Handling of non-conformance material

4-Distribution

4.1 Planning of Shipments

  • 4.1.1 There is a system in place to schedule shipments according to customer needs. Systems ensure that any changes on the previous plan is properly communicated to all parties involved in the shipping process (Sales, QA, customer service, etc...)

4.2 COA generation

  • 4.2.1 A log is maintained with the COA`s issued that contains the information of when it was sent to the customer and to which electronic address

  • 4.2.2 There is a system in place to ensure that COA`s come with correct spec limits and units

  • 4.2.3 COA`s contain the test methods used to obtain the results

4.3 Shipping

  • 4.3.1 Shipments must comply with customer requirements, safety permits, and customs regulations. For example: pallets, Organotin, REACH, labeling, etc.

  • 4.3.2 Outgoing vehicles are checked for design, structural integrity, leakage, cleanliness and all potential sources of contamination including pest infestation, dryness and absence of strong odors. These inspections are documented. Vehicles not meeting the acceptance criteria are rejected and the hauler notified. Where required, certificates of cleanliness will be supplied by the hauler. It is recommended to do a leakage inspection with the trailer door closed in order to detect leakage from floor, wall, roof and doors.

  • 4.3.3 Product is loaded into the vehicle in a way that prevents product movement during transport. Dunnage, straps, and temporary bulkheads are used as required to prevent damage; it is the responsibility of the shipping company or the forwarder to provide them. Loose items are not placed on top of palletized loads.

  • 4.3.4 There is a system for inspection of storage areas to identify and replace broken or damaged pallets. If stock is re-palletized in the warehouse, the original pallet pattern is followed. There should be a plan to eliminate all wooden pallets from the facility as they are a source of product contamination.

  • 4.3.5 Incoming and outgoing vehicles are secured/sealed to prevent tampering, adulteration or loss.

  • 4.3.6 Materials are shipped on a first in - first out (FIFO) basis.

  • 4.3.7 The status control system prevents the shipment of product not yet released, e.g. quarantined quality inspection, blocked and rejected stock. Control may depend on physical segregation, labeling or status control by a validated computer system.

4.4 Delivery

4.5 Reconciliation of shipped/invoiced

4.6 Product Handling and Storage

  • 4.6.1 Proper conditions (e.g. temperature, humidity, microbial, and dust control systems) are defined and maintained. Where required, the warehouse environment is monitored. There is a documented strategy for the actions to be taken if conditions in the warehouse go outside these limits.

  • 4.6.2 Warehouse equipment, including fork trucks and stretch wrappers must be clean, properly operated and maintained with documentation.

  • 4.6.3 Load Limits are clearly displayed on all shelves

  • 4.6.4 There is no evidence of structural damages to the shelves.

  • 4.6.5 Bundle stored in the warehouse are stacked in a safe manner with no risk of falling down (leaning, misaligned, etc..)

  • 4.6.6 Finished product is wrapped and protected from contamination and moisture prior to storage. There is an inspection of materials stored in the warehouse to ensure product protection. Damaged materials found in storage must be repaired prior to shipment or rejected.

  • 4.6.7 Product stored in trailers must be able to handle the environmental extremes without degradation. There should be a periodic inspection of material in trailers to ensure it remains suitable for use or shipment.

  • 4.6.8 "There is a defined location control strategy that includes separation of incompatible goods and allows easy and rapid retrieval of stock for shipment. Physical location matches the system records.

  • Where multiple items are stored in the same location/shelf/row, such as small quantities, residuals or slow movers, the inventory control system is capable of distinguishing between the different items and pallets. "

  • 4.6.9 Rigorous controls must be implemented any time there is off quality product that has been rejected. Rejected products should be physically separated from good product.

  • 4.6.10 For markets with extremes of temperature or humidity, insulated or temperature controlled delivery vehicles are used as necessary and as defined within approved Technical Standards.

4.7 Inventory Management

  • 4.7.1 "An inventory control strategy is used to define the order of shipment of product and the systems required to prevent shipment of over-aged or not yet released stock.

  • There is a quarantine system in place for suspect material. "

  • 4.7.2 Obsolete finished products are disposed of in a controlled manner .

  • 4.7.3 Cycle counts are performed on a regular base to ensure inventory accuracy

  • 4.7.4 In case discrepancies are found, there is a stablished process to approve the correction that include, at least, the controller and the plant manager.

  • 4.7.5 Safety stock levels are maintained according to customer regular needs and contract agreements.

  • 4.7.6 Inventory levels are tracked and have clear targets stablished.

  • 4.7.7 Aged inventory is controlled and there is a system to avoid void product to become obsolete;

5-HR

5.1 Staffing

  • 5.1.1 Manufacturing, distribution Quality, HSE and supporting operations are adequately resourced to ensure management system requirements are satisfied.

  • 5.1.2 Roles, responsibilities, and required skills are defined. Role descriptions are reviewed and updated at least every 3 years.

  • 5.1.3 There is a system for development of knowledge and competencies that will enable our employees to adapt to rapidly changing labor markets. Some developmental trainings are: Training Plans, internal training, vocational training, specialty training, cross shift training, situational leadership classes.

5.2 People Develpment

5.2.1 Qualification of personnel

  • 5.2.1.1 There is a training procedure and matrix plan (all trainings in the site vs. personnel on the site). There is a tracking system to assure individuals are qualified to perform tasks and to identify training gaps for resolution, whether individual, organizational or instructional in nature. Training records include training activity descriptions, trainer names, trainee names, dates, proficiency tests, results of qualifications, and training materials.

  • 5.2.1.2 "Personnel, including new employees, transferees, managers, temporaries and on-site contractor personnel, have a training plan that ensures individuals gain the required skills and knowledge of tasks including Fitesa’s Management Requirements (FMR) requirements and required safety trainings, associated with their role (e.g. policies, SOPs, regulations), responsibilities and expectations.

  • There must be appropriate training of temporary and contracted employees for those tasks that directly or indirectly impact the quality of the product. Initial training is required for the following:"

  • 5.2.1.3 "HSE training is key to achieving a safety culture, with that all employees shall be trained upon employment and regularly there after, if applicable to their job.

  • HSE events prevention and communication.

  • Hazard Communication.

  • Confined Space.

  • Electrical Safe Work Practices.

  • Ladder Safety.

  • Local Regulations.

  • Personal Protective Equipment.

  • Line Breaking, Hot Work, Welding.

  • Blood Borne Pathogens.

  • Emergency Action Plans, Fire Response, First Aid, CPR.

  • Lock Out Tag Out.

  • Fall Protection.

  • Hearing Conservation.

  • Mechanical Presses.

  • Respiratory Protection.

  • Lifting Equipment.

  • Powered Industrial Trucks.

  • Critical to Quality Tasks.

  • Manufacturing and Laboratory employee requalification. Managing Hazard Chemicals. Safety risk analysis/assessment. Truck (un)loading."

  • 5.2.1.4 There is a system ensuring that all employees have sufficient training and experience to perform their assigned functions. The system has effective and relevant training courses with course owners designated based on expertise. There is a list of tasks, work instructions, and SOPs for each role. Training is based upon the work instructions and SOPs. Employees are made aware of defects, failures, losses and risks which may occur from improper performance of job duties.

  • 5.2.1.5 The effectiveness of training is verified by a documented on-the-job assessment and/or a written test. Training ensures performance. If training is hands-on given by a designated expert trainer, it is still necessary to document the content of the training and the process for qualifying a person. It is not satisfactory to say that a person is qualified when the expert trainer says they are qualified. Consistency and standardization of training are the goals. Until qualification is complete, the employee cannot perform the task without qualified supervision.

  • 5.2.1.6 There is a system for training when changes occur to tasks and procedures.

5.2.3 Training

  • 5.2.3.1 Training courses have designated owners and defined qualification processes.

  • 5.2.3.2 Owners are responsible to ensure that course content is documented, relevant, sufficient and effective. (minimum documentation: # of participants, training hours, cost, evidence of training completion).

  • 5.2.3.3 Trainers have been qualified to provide training. Courses have individuals authorized to perform qualifications. These individuals are experienced and designated. Only qualified trainers are use by position and documented on a Master List.

  • 5.2.3.4 Appropriate statistical training exists for development, quality and process personnel. Statistical training focuses on applications necessary to complete assignments, such as targets, specification limits, standard deviation, random sampling, normal distributions, tests of significance, process capability, gage R&R, DOE, and tools such as Minitab.

  • 5.2.3.5 Refresher training occurs for tasks that directly affect Safety, quality and efficiency or the measure of any of these drives (such as test methods). Refresher training happens according to a pre established matrix that includes the responsibilities of the employee and the required knowledge it needs to perform the routine tasks.

  • 5.2.3.6 Performance reviews occur regularly and are documented.

5.3 Pay Roll Benefits

5.4 Union / Labor Law

6-Procurement/Supply Chain

6.1 Development of Suplier/Contractors

  • 6.1.1 There is a documented process for qualifying suppliers and contractors. There is a standard and formal process for assessing supplier quality performance including evaluation of material non-conformances. The acceptance criteria for products and services are established. There is a requirement to have corrective/preventive action procedures with the supplier.

  • 6.1.2 Supplier capability of maintaining supply and quality standards to Fitesa`s expectation is analyzed before supplier is approved.

  • 6.1.3 "Material Suppliers must be selected, qualified and approved for each supplier producing location. This includes defining materials needing qualification or those that can be excluded. Materials for on-going production are purchased only from approved suppliers/supplier locations

  • Once qualified, significant changes to these materials, their supply chain or their application are evaluated and re-qualified prior to on-going use under normal controls. "

6.2 On going Supply

  • 6.2.1 Suppliers must be evaluated based on their ability to supply product in accordance with requirements. Approval criteria is documented and reviewed. Criteria for selection, evaluation and re-evaluation must be established. Supplier evaluations are assessed via self-surveys or other quality certifications. Records of the results of evaluations and any necessary actions arising from the evaluations shall be maintained. Non conformances are reviewed as well as on time shipments.

  • 6.2.2 There is a list of qualified suppliers of service and materials. This lit includes the materials and services that each supplier is qualified in and what site of the supplier is allowed to ship materials to the site.

  • 6.2.3 Purchasing information will describe the product to be purchased, including, where appropriate, requirements for approval of product, procedures, processes and equipment, requirements for qualification of personnel, and quality management system requirements.

6.3 Inventory Management

  • 6.2.4 "This information must be available:

  • Minimal requirements

  • • Approved Technical product specification for each product and location. It includes: material identification, a list of key physical and chemical properties with test targets, limits, sample size, and test methods. It also includes unique material storage requirements, COA reporting requirements, date of specification and approvals.

  • • Safety Data Sheet (SDS) according to relevant legislation (e.g. REACH Regulation EC 1907/2006) or other relevant safety information when SDS is not applicable

  • Requirements to be reviewed with customer:

  • • Complete composition list, including Chemical Abstracts Service (CAS) numbers for all raw materials, additives and impurities, e.g. residual monomers

  • • Information on toxicological tests already performed (e.g. cell toxicity, skin irritation or sensitization tests) if it is required by customer

  • • Information on safety performance (including fire rating/compliance tests) performed if it is required by customer."

7-Maintenance

7.1 Maintenance System

  • 7.1.1 Work equipment and spare parts must comply with the machinery directive and the provisions of occupational health, safety and environmental requirements.

  • 7.1.2 There is a written procedures describing maintenance process and activities.

  • 7.1.3 Systems are in place for both planned and non-planned maintenance of facilities and equipment.  These systems ensure necessary conditions are meet to achieve product quality requirements and validations are maintained.

  • 7.1.4 Before starting any maintenance activities, all potential safety hazard are evaluated, identified and mitigated.

  • 7.1.5 During maintenance activities product contamination is prevented .

  • 7.1.6 Key equipment must be identified for maintenance

  • 7.1.7 "All maintenance work is documented. Data includes:

  • - Equipment identification;

  • - Reason for the work and what was done;

  • - Who and when job was performed;

  • - Components that are replaced and/or any service cost/expenses."

  • 7.1.8 Executed maintenance work are reviewed for further improvement opportunities, trends analysis or prioritization (pareto).

  • 7.1.9 Maintenance service is checked before equipment return to operations and whenever applicable Change Control procedure is followed

  • 7.1.10 The use of temporary repair materials (i.e. tape, silicone sealant, wood) on equipment is not allowed.  Repair materials used are compatible with products manufactured or stored at the facility.  There are change control processes for approval of product-contact items such as adhesives, gaskets and hoses.  Product contact materials cannot be substituted during maintenance without change control.

  • 7.1.11 Spare parts inventory accuracy are maintained and there is a replenishment strategy defined for these items.

  • 7.1.12 Scrap and obsolete materials are disposed of to minimize the risk of contamination and their inadvertent use and misuse.

  • 7.1.13 KPIs and Data are applied to measure maintenance performance and drive improvement efforts.

7.2 Preventive Maintenance

  • 7.2.1 Preventive Maintenance master plan exist and it is shared with customer service and operations teams. Frequency and expected downtime are established by type of service for key equipment;

  • 7.2.2 "Preventive maintenance is structured on a database and includes:

  • • Calibration Plans

  • • Lubrication Plans

  • • Replacement of parts for lifetime

  • • Exchanges of pieces per manufacturer specifications

  • • Problems encountered from Predictive Maintenance

  • • Chronic or recurrent problems

  • • Safety problems

  • • Quality problems

  • • Process problems

  • • Machine design problems

  • • Problems generated by emergency corrective maintenance

  • • Problems created due to poor OLA."

  • 7.2.3 There is a lubrification and calibration master plan for key equipment and systems with potential product impact

  • 7.2.4 Lubrification: There is a system in place for approval and management of lubricants.  The system defines where each can be used, which lubricants must be food grade, and how lubricants are to be labeled and stored.  Food grade lubricants are used in equipment where the lubricant could possibly come in contact with the product through leaks or spills.  If non-food grade lubricants are also used, the two grades must be clearly distinguishable to prevent mix ups.

  • 7.2.5 "Calibration: Labs and Equipment instruments and measurements devices critical for safety, quality or efficiency are calibrated against a standard at a frequency specified in a written calibration procedure. The procedure includes tolerances/accuracy, operating range of equipment and external reference used. The external reference used must be traceable to official government standards (whenever needed).

  • Where necessary to ensure valid results, measuring equipment shall:

  • a) be adjusted or re-adjusted as necessary;

  • b) have identification in order to determine its calibration status;

  • c) be safeguarded from adjustments that would invalidate the measurement result;

  • d) be protected from damage and deterioration during handling, maintenance and storage."

  • 7.2.6 Scheduled maintenance down day: There is a process to determine when maintenance down days will happen. This process is documented in a procedure and the maintenance down days happen frequently.

  • 7.2.7 Preliminary meeting with staff and / or suppliers:  This meeting is performed when the expert considers it necessary for the alignment of information during the discussion of needs for a down day. It is important to clarify responsibilities of each person in the meetings and the deadlines to be met.

  • 7.2.8 Analysis of results: The preventive maintenance specialist or maintenance manager should make an analysis of the results of his down day.  This analysis verifies the work execution (time and activities) and lessons learned. In case of activities not executed, these must be re-planned accordantly.

  • 7.2.9 Maintenance Routes are performed as part of the Daily Work Routine Management by the Maintenance or Operations personal. When deviations are found during the route a corrective or preventive work order is created.

  • 7.2.10 Buildings (Offices, shop floor, warehouses and external areas) must have a cleaning plan. It is suggested to include overhead cleaning for productive areas.

  • 7.2.11 Utilities are included in the Preventive master plan: Building, piping, and energy management.

7.3 Predictive Maintenance

  • 7.3.1 PREDICTIVE  MAINTENANCE – Systems are in place and documented for facilities and equipment.  These systems ensure facilities and equipment conditions necessary to achieve product quality requirements are in place.

  • 7.3.2 The predictive maintenance techniques that are already in use will be monitored through graphs.  These graphs will measure the efficiency of the applied techniques and the evolution of anomalies. The graphics are divided into two for each technique. There is a graphic to control the monitored points and a graphic to control the anomalies.

  • 7.3.3 Measurements that will be made by maintenance technicians must follow the Work Instructions corresponding to the type of analysis used in order to ensure uniformity of services.  After checking the types of analysis that will be used, the criteria for evaluation should be defined (MOC)

  • 7.3.4 "Examples of Predictive Maintenance Techniques suggested are:

  • Thermographic Analysis on Electrical Panels;

  • Vibration (Online or Offline) Analysis for bearings and rotation parts;

  • Laser alignment for motors, shafts and gearboxes;

  • Ultrasonic sensors for compressed air leakages;

  • Amperage Measurements Devices for Energy Management;"

8-Financial Management

8.1 Closing

8.2 tax return

8.3 cash management

8.4 insurance

8.5 EMM

8.6 Miscellaneous

9-Waste Management

9.1 Waste Management System

  • 9.1.1 Waste is sent for licensed environmental partners which are in compliance with local regulation.

  • 9.1.2 All areas have designated waste containers that are regularly emptied, and properly covered. Refuse containers are located away from sensitive operations.

  • 9.1.3 Raw and packing material shipping containers can be used for waste disposal only if limited to single-use, all original labels are completely removed or obliterated, and the container is cleaned and is clearly labeled as waste.

  • 9.1.4 A written procedure for Waste Management is established and describes the kinds of waste, and the handling, storage (including labeling and compatibility), monitoring and documentation.

  • 9.1.5 There is a strategy in place to control general recyclable waste.

  • 9.1.6 Volume of waste generated on the site is monitored by type of waste. There is a goal established to not increase the amount of waste generated or reduce the amount of waste generated and sent off site. There are documented manifests tracking waste disposal.

10-Information Management

10.1 Archiving

  • 10.1.1 Computer systems are designed with adequate capacity, password protection, redundancy and backups.

10.2 Other Communication

  • 10.2.1 There is a system to control and store SDS of all raw materials and chemicals used at the plant. This system ensures that information is easily accessible to all employees

  • 10.2.2 Employees know SDS system and how to access the information

  • 10.2.3 Site is compliant to GHS and all containers are labelling according to the standard.

  • 10.2.4 There is a master list of all chemicals used/stored at the site;

  • 10.2.5 Evidence of sustainability tracking and annual reporting

  • 10.2.6 The facility front view displays the current logo.

  • 10.2.7 The unit’s official pages on social media displays the current logo.

  • 10.2.8 The following materials show the company’s logo: business cards, letterheads, powerpoint presentations, hand samples (packaging and/or labels).

  • 10.2.9 When used, the following materials will also show the company’s logo: employee badges and uniforms.

  • 10.2.10 "All branded materials display the current logo. Branded materials no longer in use, such as previous version of documents, do not need update and may have the visual identity present at the time of its validity.

  • *In the case of a change in visual identity, facilities will be considered compliant according to the action plan deadlines set at the time of the rollout.

  • "

10.3 Records

  • 10.3.1 The organization has established a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.

  • 10.3.2 There is a written procedure for backing up and restoring computer or other electronic records.

10.3.3 Handling of records

  • 10.3.3.1 Electronic regulatory records (e.g. SDSs, permits, product safety) must meet all applicable regulations and company policies.

  • 10.3.3.2 Computer and paper records are complete, accurate, secure, and retrievable. Records are retained per a defined policy. Paper records are completed in ink.

  • 10.3.3.3 Records include the name/signature of the person completing a record.

  • 10.3.3.4 Proper error correction is utilized: single cross out of error, entering the correct data, reason for the change (required for GMP products only), date and initials of the person making the change. Records kept on a computer system must maintain an audit trail of changes.

10.3.4 Retention and Storage of Records

  • 10.3.4.1 Storage areas for records are clean and have appropriate environmental controls.

  • 10.3.4.2 Records will be maintained for a minimum of 3 years or for the period requested by customer.

  • 10.3.4.3 Safety and Sustainability related records are stored for 3 years or the minimum legal retention requirement.

  • 10.3.4.4 Records should be maintained for systems in the plant to document and prove effectiveness

10.4 Process and Organization Meetings

  • 10.4.1 Monthly Reviews: Metrics are reviewed periodically. The behavior and performance of site leadership shall provide evidence of its commitment to the development and implementation of the FMR requirements and continually improving their effectiveness.

  • 10.4.2 "General Business Review Meetings: All the teams shall assess and review the previous month results. This shall include: ▪ Safety: RIR; number of near misses; closure rate; number of incidents (environmental, safety, equipment damage)

  • ▪ Customer feedback and other quality measurement trends

  • ▪ Status of Quality Objectives

  • ▪ Quality systems audit results

  • ▪ Status of Corrective and Preventive actions

  • ▪ Training status and future requirements

  • ▪ Status of procedure development and reviews and DTO results

  • ▪ Process Control Plan and product conformity

  • ▪ Recommendations for improvement

  • ▪ Process performance and product conformance

  • ▪ The FMR requirements and actions to become more effective

  • ▪ Ensured resources are available for corrective/preventive actions and for improving the effectiveness of the FMR requirements. "

  • 10.4.3 During the monthly KPI review meeting (Plant Business Review Meeting), the KPI’s (Key Performance Indicators) for each area are reviewed, posted in work area and, if a YTD or monthly goal is not being achieved an Countermeasures Action Plan report has to be presented. Tools like Pareto Charts and Ishikawa Diagrams are used to find the root causes. Action plans are followed up on a monthly basis.

  • 10.4.4 General Business Review and Plant Business Review Meetings are scheduled for every month on an annual calendar.

10.5 Traceability

  • 10.5.1 "A Traceability Exercise must be performed at least on a yearly basis for one lot material for every line, it contains: (format C.RE-4.2-03)

  • Material Description, Specification Number, Production Date(s) and Time(s), Raw Material Receipt Documentation, Raw Material Compliance with Specification, Raw Material QA Release, Lot Size and Procedures Determining Lot Size and Numbering, Process Audits, Unplanned Downtime,

  • Process Standards, Finished Product Compliance with Specification, Laboratory Test Methods, Finished Product QA Release, Quantity Delivered to each Customer Site, Truck Inspection Records, Finished Product FIFO, Customer Complaints, comparison of total amount produced with raw materials used and yield. Do amounts agree within reason?

  • Main raw materials used (e.g. resin and pigments).

  • Which Finished Product lots contain raw material lot ?, Which Customer(s) received these lots?, What are the ship dates?, Is any material remaining in Inventory?"

11-Improvement and Change

11.1 Case Management

11.1.1 Customer Claims

  • 11.1.1.1 Upon arrival/receipt, untouched loads refused by a customer and returned to our warehouse unopened are inspected for transport damage. If the delivery vehicle has been unloaded en-route or at the customer, or the return has been delayed, or if there is any question as to its storage history meeting standards, then the load is treated as a trade return except where prohibited by local regulations. Returned materials are treated as inventory and are subject to the inventory management system requirements. They are inspected upon receipt and dispositioned as appropriate. If the condition of the product casts doubt on the quality, the product is destroyed unless there is a documented examination or other testing to show the product complies with standards.

  • 11.1.1.2 There is a system in place to receive, investigate, document and follow-up on all verbal and written consumer and customer comments (e.g. inquiries, complaints or testimonials). Consumers and customers who contact us are handled promptly and in a professional manner.

  • 11.1.1.3 "The system includes:

  • - Defined initial points of contact.

  • - Training and qualification of the persons responsible for conducting incident investigation, recording customer complaints and consumer comments, receiving, recording, responding to routine inquiries and classifying the nature and severity of the incident and complaint.

  • "

  • 11.1.1.4 Communication with employees and customers is a critical step in incident and complaint resolution. Communications should be timely and documented. Verbal communications are documented in a log.

  • 11.1.1.5 There is a system in place to evaluate the nature and severity of safety incidents, consumer comments, customer complaints which determine the extent of investigation and follow-up actions to be taken.

  • 11.1.1.6 "Severe and Quality System Failure complaints are tracked and managed with urgent attention. First response to sent customer within 2 days. it must contain:

  • -Acknowledgement of the receipt;

  • -Initial investigation and possible causes;

  • -Orientation to the customer to hold more material until final investigation is concluded (if applicable);

  • -Next steps;"

  • 11.1.1.7 "Complaints must be closed within 30 days. This includes:

  • -Investigation with root cause concluded;

  • -Action plan stablished;

  • -Credit to customer authorized;

  • -Customer communicated of results of the investigation;

  • "

  • 11.1.1.8 "Quality complaints and their severity are tracked, identified, corrective actions plans initiated and reported. The site will establish procedures and records that include:

  • 1. The use of criteria and/or appropriate statistical methodology to analyze available data (such as audit reports, defects, service records, complaints, returns, operational data, etc.) to identify non-conformities (e.g. system failures).

  • 2. The investigation of root causes and the planning of corrective and preventative actions by cross-functional team participants. Temporary corrective actions may be necessary until permanent solutions can be implemented.

  • 3. The verification of the effectiveness of corrective and preventative actions taken.

  • 4. The site has a clear monitoring that show the most frequent cause of complaints or negative customer feedback. The top items are being diligently addressed.

  • "

  • 11.1.1.9 "All claims are documented as follows:

  • a) quality incident :a quality system failure or the full or partial absence of a needed quality system that risks compromising the quality and integrity for example material contamination

  • b) significant quality incident: A quality incident that has costs greater than $100,000 USD or actual/potential consumer risk

  • c) material is involved in the claim

  • d) finished product of the customer is involved.

  • e) comments from customer but no material is involved

  • f) repeat Quality Incident – A Quality Incident is considered a Repeat Quality Incident when it is from the same Fitesa site, the same quality system failed, has the same Root Cause, and occurred in the previous 2 years.

  • g) quality alert – A quality system failure that was caught early at Fitesa site without impact.

  • "

  • 11.1.1.10 An action plan is developed based on the outcomes of investigations. Where required by regulation or certification, the action plan conforms to CAPA (Corrective and Preventative Actions), such as to include documented evidence that the actions taken were systemic and verified to be effective. Root cause analysis is developed with cross-functional participation.

  • 11.1.1.11 Repeated quality system failures are tracked and managed with more attention than stand alone customer complaints; they require to be solved starting from root cause elimination.

  • 11.1.1.12 The customers' order review process is documented, communicated, maintained, and responsive (reacts in a timely manner).

11.1.2 Product Development

  • 11.1.2.1 All trial materials must be validated and compliant with regulatory standards.

  • 11.1.2.2 "Inputs relating to product requirements shall be determined and records maintained. These inputs shall include:

  • a) functional and performance requirements,

  • b) applicable statutory and regulatory requirements,

  • c) where applicable, information derived from previous similar designs, and

  • d) other requirements essential for design and development.

  • e) trial material must be checked for safety and environmental hazards before using."

  • 11.1.2.3 "The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer and shall ensure that:

  • a) product requirements are defined,

  • b) contract or order requirements differing from those previously expressed are resolved, and

  • c) the organization has the ability to meet the defined requirements.

  • Records of the results of the review and actions arising from the review shall be maintained."

  • 11.1.2.4 In case of a global developments (same material being produced in other locations) it is mandatory that one of the steps of qualification is to prepare a statistical study to ensure materials are equivalent.

  • 11.1.2.5 Product Design & Development follows an established work process with reviews planned at established intervals (e.g. phases, gates, etc.) that include QA, HS&E, and other qualified resources.

  • 11.1.2.6 Test product should be identified to prevent mix-up.

  • 11.1.2.7 Product Specifications include: name, effective date, issue or revision number, required approvals, intended market, complete listing of raw materials, % or weight of raw materials with tolerances, final product weight, length or size, manufacturing instructions where appropriate, finished product and in-process variables and attributes – including reference test methods.

11.1.3 Deviation from budgeted plan

  • 11.1.3.1 There is a process established to analyze out of target KPI`s. This includes root cause analysis.

  • 11.1.3.2 Out of target KPI`s have an associated action plan addressing root causes identified, The action plan is updated and easily accessed.

  • 11.1.3.3 Information from the case is delivered to MBR to be properly communicated with the site and the rest of the organization.

11.1.4 Safety & Injuries

  • 11.1.4.1 HS&E incidents are categorized as indicated in Global Procedures.

  • 11.1.4.2 There is documented evidence that proper actions was taken based on the safety alerts shared by the other Fitesa sites.

11.1.5 Capital Investments

  • 11.1.5.1 All new buildings, equipment, and computer systems are designed with product quality considerations and with the approval of the site QA responsible.

  • 11.1.5.2 All changes that will affect sites structure (increased capacity, new buildings, etc..) are analyzed by leadership and technical teams to ensure that enough resources are available to maintain all implemented process fully operational and with no disturbance to the site performance (QA and operational)

  • 11.1.5.3 A validation process should be established to assure that a Health, Safety and Environmental (HSE) and Quality review and release is conducted prior to the approval of scope of new equipments acquisitions and modifications or renovations to buildings and equipments.

  • 11.1.5.4 Normal operating standards are maintained during construction and modification to facilities, equipment and utilities. Contamination abatement plans are approved by Quality Assurance.

  • 11.1.5.5 A Project must have amount and scope of project needs, financial and viability checks, opening of a CI form to start the project, performance of regular periodic physical and financial monitoring, and final delivery of the finished project. Validation procedures must be followed.

  • 11.1.5.6 Monitoring of the project is accomplished through some tools such as validation checklists, meeting minutes, physical and financial schedules, and indicators such as safety, costs, and lead time are exposed to management personnel.

  • 11.1.5.7 "The project designs are defined in meetings. In these meetings, the projects are prioritized in order to determine which are strategically more important and relevant to discuss.

  • In case of changes on the planned CAPEX to relocate funds to a different project, the decision and approval process is documented with all interested areas."

  • 11.1.5.8 The project leader is also responsible for recording milestones, critical analyses and outputs of the project.

  • 11.1.5.9 Project spending and activities are scheduled using Gantt charts or similar tools.

  • 11.1.5.10 The Project's progress is tracked using standard S curves for Cost Control and Time Schedules.

  • 11.1.5.11 In the case of investments, the aspects of labor, health and environmental protection are considered from the outset and have influence on the selection.

  • 11.1.5.12 "Each Fitesa facility should maintain a updated and prioritized Chronic Problems List or Project Hopper.

  • ▪ All employee input is considered to build this list.

  • ▪ Annually, the list should be reviewed, prioritized and updated by senior management of each site prior to annual budget development activities.

  • ▪ The prioritization is based on a number of weighted factors such as safety, yield improvements, cost improvements, etc.

  • ▪ The chronic issues affecting a plant's annual goals are resolved in a focused and orderly manner."

11.2 Action Plan Management

  • 11.2.1 Action plan management is in place. A system is stablished were actions can be easily managed and late action can be identified. System has updates complete information.

11.3 .Risk Analisys Tools

  • 11.3.1 There is a systematic FMEA process on site according to global procedure;

  • 11.3.2 Customer Feedback is periodically reviewed on FMEA to ensure the risk assigned to the failure modes are meaningful and if new failure modes have to be added after root cause analysis

  • 11.3.3 Employee feedback is analyzed and, when appropriate, included as a failure mode on FMEA

  • 11.3.4 FMEA is reviewed at least every quarter;

  • 11.3.5 There are actions for the highest RPN failure modes in order to reduce/eliminate the risks. The updated RPN after plan is concluded is recorded to demonstrate effectiveness.

  • 11.3.6 There is a systematic Risk Assessment process on site according to global procedure;

  • 11.3.8 Employee feedback is analyzed and, when appropriate, included in the risk Assessment

  • 11.3.9 Risk Assessments structure are reviewed at least every 5 years;

  • 11.3.10 There are actions for the highest RPN in order to reduce/eliminate the risks. The updated RPN after plan is concluded is recorded to demonstrate effectiveness.

11.4 Validation and change control

  • 11.4.1 "There is a documented validation written procedure that that is based on the corporate standard and includes:

  • - Established and documented goals for validation.

  • - Established and documented protocol including sampling requirements and a range of normal operating conditions.

  • - Qualification of measurement equipment.

  • - Qualification of equipment or process.

  • - Determination of release criteria for material made during the validation activity as part of the validation protocol.

  • - Evaluation of validation data versus acceptance criteria with statistical significance.

  • - Documented reports and their archiving

  • - Establish change control specifying what changes must be submitted for approval. Changes must be identified that require revalidation. New validation protocols are developed and approved based on the changes identified.

  • The Fitesa Corporate procedure is used as a guide"

  • 11.4.2 "A written validation Master Plan will be established for equipment, processes, systems, and methods. The Master Plan will list all systems to be validated, type of validation when revalidation is due, who is accountable for the revalidation, a reference to the validation protocol, and tracking of completion of items versus plan. The Validation Master Plan is approved and regularly reviewed for completeness.

  • This list will establish if validation is required or not; if validation is not required an explanation is needed.

  • The Fitesa Corporate template shall be used for the Master Plan."

  • 11.4.3 QA approves all master plans and individual protocols and reports.

  • 11.4.4 "Process validation for new or modified processes includes (IQ, OQ, PQ, V)

  • Installation Qualification (IQ) is a static check that equipment meets the design intent and is properly installed and utilities are properly connected.

  • Operational Qualification (OQ) is a dynamic check testing the full operating range.

  • Performance Qualification (PQ) is a process validation covering short-term (1 run) and long-term (3 runs) capability within the normal operating range.

  • Verification (V) is long-term process verification. The long-term variability includes multi-users, multiple lots of materials, multiple set-ups, etc."

  • 11.4.5 Critical parameters, sampling plan requirements and success criteria are established and documented in the validation protocol.

  • 11.4.6 "Test methods are validated before use against specific success criteria that are related to the intended use and requirements of the method.

  • Test method validation is completed before use and includes variation (Gage R&R) studies and accuracy (laboratory co-ops) studies. Test method validation is documented and added to the validation master plan."

  • 11.4.7 New or significantly changed processes, equipment, test methods and systems require validation.

  • 11.4.8 Computer validation or verification is required for any system that deals directly with or supports Quality Assurance, including process control. IQ, OQ, PQ, V should be followed as appropriate based upon the maturity and risk involved in a new or modified computer system. For extensive modifications the full validation process should be followed, for minor changes PQ and V should be utilized. Items to be included in validation: data integrity, security, error detection, information transfer, data analysis, data storage capacity, data buffer volume, and data backup systems.

  • 11.4.9 Production systems and procedures that affect quality assurance should be validated.

  • 11.4.10 "There is a defined process for establishing new product design or improved products. The process and documents include:

  • ▪ Customer, functional and performance requirements

  • ▪ Product Safety, Statutory and regulatory requirements

  • ▪ Design and Development Planning

  • ▪ Design verification / validation

  • ▪ Product protection (packaging needs)

  • ▪ Design Transfer requirements and Prototype planning

  • Product validation ensures that products meet safety and efficacy requirements, are suitable for manufacturing on commercial equipment, and ensures product integrity, durability, compatibility, sufficiency, performance, accuracy of design and addresses regulatory concerns. Product design reviews and conclusions are documented."

  • 11.4.11 There is an internal validation committee stablished involving the leaders of the key operational areas (QA, Maintenance, operations and logistics) that meets regularly to review change control protocols and determine the validation procedures and actions that must be performed.

  • 11.4.12 "Approved validation plans, procedures, protocols and reports are consistent with the nature and scope of the project, detailing the specific success criteria supported by statistical analysis of the data and summarizing data that support the conclusions.

  • Protocols are written and approved prior to the validation.

  • Validations are conducted in either a concurrent or prospective manner. Retrospective validations are not acceptable. Older validations must be reviewed to ensure they are current and compliant to applicable regulations, Company policies and SOPs.

  • "

  • 11.4.13 Where required, label validation is completed with change control in place.

  • 11.4.14 "Every validation is summarized into a report that includes project leader name, team participants, date, acceptance criteria, results, and conclusions.

  • Revalidation follows the same principles."

  • 11.4.15 Validation documents are kept as long as the process, analytical method, product, production system and/or procedure exists.

  • 11.4.16 There is a documented change control procedure that is based on the corporate standard and specifies the processes used and approvals required (including QA) when changes to current products, systems, processes and procedures are required.

  • 11.4.17 Change control systems exist to ensure that existing processes remain validated and changes are fully deployed through affected systems.

  • 11.4.18 The impact of changes to materials, product, processes and personnel is evaluated by competent individuals prior to the implementation of the change.

  • 11.4.19 If a change is not consistent with an existing validation, a documented revalidation is conducted prior to implementation of the change. The extent of the revalidation is to be determined as part of the change control process.

  • 11.4.20 Changes are deployed through all affected systems through the use of training, procedures, records, technical standards, process control strategies, etc.)

  • 11.4.21 Deviations from qualified standards and specifications require documented review and approval in compliance with customer requirements.

Audit Completion

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