EML(05-20-2016) BRC Monthly Internal Audit issue 5

• Document No. Release date 12-12-2014

• This audit document is to be used to determine the adequacy of the plants quality, product safety, HACCP, and related programs to a BRC Basic Hygiene Global Standard for Packaging and Packaging Materials (issue 5). Please include conformance and non conformance documentation during the audit. When completed review with the manager(s) of the department reviewed or the Quality Manager or General Manager if for a larger area.

• Audit Title.

• Client / Site

• Conducted on

  Date

• Prepared by:

• Location
  Address

• Personnel

SECTION 1 SENIOR MANAGEMENT COMMITMENT

• Does this unit cover Section 1

  Yes

  No

  N/A

• 1.1 SENIOR MANAGEMENT COMMITMENT AND CONTINUAL IMPROVEMENT- FUNDAMENTAL The company's Senior Mgmt shall demonstrate that they are fully committed to the implementation of requirements of the Global Standard for the Packaging and Packaging Materials. This shall include provision of adequate resources, effective communication and systems of review to ensure Continual Improvement. Opportunities for improvement shall be identified, implemented and fully documented.

• 1.1.1 Does site have documented policy? is it signed off by GM? How is it communicated? Does it express responsibility to its customers and to produce quality, safe and legally compliant products?

  compliant

  nc minor

  nc major

  N/A

• 1.1.2 Employees demonstrate understanding of product safety and quality policy? Have objectives been established? Targets established and monitored, results reviewed annually and communicated to senior management? Confirm records of review meetings at least annually?

  compliant

  nc minor

  nc major

  N/A

• 1.1.3 Is there full support from senior management to the QMS and Product Safety program to maintain compliance with standard?

  compliant

  nc minor

  nc major

  N/A

• 1.1.4 Is there a documented procedure to ensure the company is informed of scientific and technical developments? Industry codes, relevant legislation in countries of manufacturing and usage? Changes to the BRC standard or protocol? who is responsible?

  compliant

  nc minor

  nc major

  N/A

• 1.1.5 Is an electronic or hard copy of the BRC standard available?

  compliant

  nc minor

  nc major

  N/A

• 1.1.6 Are recertification audits scheduled and confirmed within prescribed deadline?

  compliant

  nc minor

  nc major

  N/A

• 1.1.7 Did most senior production/operations manager participate in opening and closing meeting of the Global Standard audit? Relevant department managers or their deputies available during the audit?

  compliant

  nc minor

  nc major

  N/A

• 1.1.8 Are all corrective actions from previous BRC audit addressed? is there a system to close out nonconformities from internal, second or third party audits based on root cause?

  compliant

  nc minor

  nc major

  N/A

• 1.2 MANAGEMENT REVIEW- The site's senior management shall ensure that a management review is undertaken to ensure that the product safety and quality system is both fully implemented and effective, and that opportunities for improvement are identified.

• 1.2.1 Are management review meetings attended by the senior management team? are they undertaken at planned intervals, at least annually?

  compliant

  nc minor

  nc major

  N/A

• 1.2.2. Has this review included previous review documents? action plans and timeframes? Results of all audits? performance indicators, complaints and feedbacks? Review of HACCP? Incidents, corrective actions and nonconforming materials? resource requirements? performance against standard and objectives? and effectiveness of root cause analysis and corrective actions?

  compliant

  nc minor

  nc major

  N/A

• 1.2.3. Are there documented minutes of the management review and any action plans?

  compliant

  nc minor

  nc major

  N/A

• 1.2.4. Have any product safety, legality and quality issues been brought to the attention of senior management for immediate action? have the minutes been shared with corresponding corporate officer?

  compliant

  nc minor

  nc major

  N/A

• 1.3 ORGANIZATIONAL STRUCTURE, RESPONSIBILITIES AND MANAGEMENT AUTHORITY- The organizational structure shall be clear, with defined responsibilities, and key staff shall be aware of their responsibilities with regard to packaging safety and quality.

• 1.3.1 Is the organization chart current? Is there a designated representative and back up for overseeing compliance to the standard? Does it show HACCP and BRC primary and deputy responsibilities?

  compliant

  nc minor

  nc major

  N/A

• 1.3.2 Do all employees have access to work instructions

  compliant

  nc minor

  nc major

  N/A

SECTION 2 HAZARD AND RISK MANAGEMENT SYSTEM

• Does this audit cover Section 2

  Yes

  No

  N/A

• 2.1 HAZARD AND RISK MANAGEMENT TEAM- The hazard and risk management system shall be managed by a multidisciplinary team competent in hazard and risk analysis.

• 2.1.1 Is there a multidisciplinary team in place? Is the team leader trained on HACCP principles? Outside expertise sought / required?

  compliant

  nc minor

  nc major

  N/A

• 2.2 HAZARD AND RISK ANALYSIS- FUNDAMENTAL. A documented hazard and risk management system shall establish the effectiveness of the site's prerequisite programs and identify any further risks to the safety, quality and legality of products.

• 2.2.1 Does the HACCP program scope covers all products and processes?

  compliant

  nc minor

  nc major

  N/A

• 2.2.2 Do risk assessments take into account historic data, known hazards, relevant codes and guidelines, legislative requirements?<br>

  compliant

  nc minor

  nc major

  N/A

• 2.2.3 Is there a full description of product including composition, raw materials and intended use?

  compliant

  nc minor

  nc major

  N/A

• 2.2.4 Is process flow diagram current? Includes all steps from receipt of raw materials through production and returns from customer? Is flow verified by HACCP Team?<br>

  compliant

  nc minor

  nc major

  N/A

• 2.2.5 Has the product safety team identified any new or changed hazards and analyzed for risk since last audit? Have the following items been considered, foreign objects, legality, chemical contamination, hazards impacting functionality and potential for unintended migration into food?<br><br>

  compliant

  nc minor

  nc major

  N/A

• 2.2.6 Have control measures been identified to reduce hazards to acceptable levels? are prerequisites programs in place?

  compliant

  nc minor

  nc major

  N/A

• 2.2.7 Control points have been reviewed to evaluate if prerequisites are effective in providing control? Are improvements to the programs considered if necessary?

  compliant

  nc minor

  nc major

  N/A

• 2.2.8 Are critical limits defined? are they measurable and documented? Are legislation and codes of practice condidered?

  compliant

  nc minor

  nc major

  N/A

• 2.2.9 Is a monitoring system defined to ensure compliance to critical limits? Are records and documented procedures maintained and included in internal audits when required?

  compliant

  nc minor

  nc major

  N/A

• 2.2.10 Are corrective actions established and monitored when out of limit and applicable?

  compliant

  nc minor

  nc major

  N/A

• 2.2.11 Has the HACCP program and related prerequisite programs been reviewed annually by team members including process changes, product composition, complaints, product failures, recalls and withdrawals, internal audits of PRPs, result of external audits and new developments in the market affecting materials, process or product?

  compliant

  nc minor

  nc major

  N/A

• 2.3 EXEMPTION OF REQUIREMENTS BASED ON RISK ANALYSIS- The hazard and risk analysis study shall be fully supported by the implementation of the prerequisites set out in requirements clauses 4 to 6. However, the hazard and risk analysis may indicate that some of the requirements may be exempted.

• 2.3.1 Are any BRC Elements Not Applicable to FDC? Is a Risk Analysis on file documenting N/A status?

  compliant

  nc minor

  nc major

  N/A

• 2.3.2 Are records of exemptions documented and maintained for review?

  compliant

  nc minor

  nc major

  N/A

SECTION 3 PRODUCT SAFETY AND QUALITY MANAGEMENT

• Does this audit over Section 3

  Yes

  No

  N/A

• 3.1 PRODUCT SAFETY AND QUALITY MANAGEMENT SYSTEM- The site's processes and procedures to meet the requirements of this standard shall be documented to allow consistent application, facilitate training, and support due diligence in the production a safe and legal product.

• 3.1.1 Quality Manual is available for review & Work instructions are current and properly documented in a readily accessible system? <br>

  compliant

  nc minor

  nc major

  N/A

• 3.1.2 Are QM & documented procedures fully implemented, reviewed at appropriate planned intervals and improved if necessary?

  compliant

  nc minor

  nc major

  N/A

• 3.2 DOCUMENTATION CONTROL- An effective document control system shall ensure that only the correct versions of documents, including recording forms are available and in use.

• 3.2.1 Is there a documented procedure to manage documents? is there a list of controlled documents? authorization evidence? a record of reason for changes? replacement system when updating documents?

  compliant

  nc minor

  nc major

  N/A

• 3.2.2 Are all documents and records maintained electronically password protected or on a protected drive?

  compliant

  nc minor

  nc major

  N/A

• 3.3 RECORD KEEPING- The site shall maintain genuine records to demonstrate the effective control of product safety, legality and quality

• 3.3.1 Are records legible, maintained in good condition and retrievable? Are all electronic records backed up?

  compliant

  nc minor

  nc major

  N/A

• 3.3.2 How are changes to records documented? are alterations authorized and justification recorded?

  compliant

  nc minor

  nc major

  N/A

• 3.3.3 Is there a procedure for the control of records relating to product safety, legality, regulatory compliance and quality?

  compliant

  nc minor

  nc major

  N/A

• 3.3.4 Is there documentation and a list of how records are maintained? are retention times equivalent to usable life of the product?

  compliant

  nc minor

  nc major

  N/A

• 3.4 SPECIFICATIONS- FUNDAMENTAL. Appropriate specifications shall exist for raw materials, intermediate and finished products, and any product or service that could affect the quality of the finished product and customer requirements.

• 3.4.1 Are there detailed and accurate specifications ensuring compliance with product safety and legislative requirements?

  compliant

  nc minor

  nc major

  N/A

• 3.4.2 Is there a formal agreement with the customer regarding specifications?

  compliant

  nc minor

  nc major

  N/A

• 3.4.3 Are there compliance letters on file to ensure nature of materials, legal requirements in country of manufacture and use, post consumer recycled materials content?

  compliant

  nc minor

  nc major

  N/A

• 3.4.4 Is there a formal trademark agreement between FDC and the customer? Is there documentation confirming proper destruction of trademarks when applicable?

  compliant

  nc minor

  nc major

  N/A

• 3.4.5 Is there a specification review process in place? How often?

  compliant

  nc minor

  nc major

  N/A

• 3.5 INTERNAL AUDITS- FUNDAMENTAL The company shall be able to demonstrate it verifies the effective application of the requirements of the Global Standard for Packaging and Packaging Materials through internal audits

• 3.5.1 Are Internal audits planned, current and covering all aspects of the hazard and risk management system, prerequisites and procedures? Schedule documented? All elements covered each year?

  compliant

  nc minor

  nc major

  N/A

• 3.5.2 Is the scope and frequency of the audit adequate based on risk and previous performance?

  compliant

  nc minor

  nc major

  N/A

• 3.5.3 Are auditors trained, competent and independent of process being audited? <br>

  compliant

  nc minor

  nc major

  N/A

• 3.5.4 Are conformity and non-conformity documented? Results notified to personnel responsible for the process? CPARs completed for any findings? Actions verified?

  compliant

  nc minor

  nc major

  N/A

• 3.6 SUPPLIER APPROVAL AND PERFORMANCE MONITORING- The company shall operate effective, documented procedures for approval and monitoring of its suppliers.

• 3.6.1. Is there a documented process in place for new supplier approval & ongoing supplier evaluations with records on file? Are these procedures based on risk to product safety, quality and legality? Are materials and subcontracted processes covered?

  compliant

  nc minor

  nc major

  N/A

• 3.6.2 Does the supplier approval program has clear criteria for assessment? does the assessment include either supplier audits, supplier certification to known standard or GFSI scheme, or supplier questionnaires? Is there an updated list of approved suppliers?

  compliant

  nc minor

  nc major

  N/A

• 3.6.3 Are records of supplier assessments maintained, reviewed and available?

  compliant

  nc minor

  nc major

  N/A

• 3.6.4 Are exceptions addressed in the supplier evaluation procedure?

  compliant

  nc minor

  nc major

  N/A

• 3.7 MANAGEMENT OF SUBCONTRACTED PROCESSES- Subcontractors shall be managed effectively to prevent any risk of contamination or damage and ensure that product is produced to specification.

• 3.7.1 Has the use of subcontractors been shared with brand owner and/or customer along with the subcontractors status in relation to the BRC Standard?

  compliant

  nc minor

  nc major

  N/A

• 3.7.2 Is the use of subcontractors assessed in the risk analysis on the quality and safety of the product? if any risks detected, are they communicated to relevant personnel and effectively managed?

  compliant

  nc minor

  nc major

  N/A

• 3.7.3 Are clear specifications agreed with subcontractor on any outsourced work?

  compliant

  nc minor

  nc major

  N/A

• 3.7.4 Is compliance to specifications clearly documented with process of verification of finished work to ensure safety and quality meet specifications?

  compliant

  nc minor

  nc major

  N/A

• 3.8 MANAGEMENT OF SUPPLIERS OF SERVICES- The company shall be able to demonstrate that where services are outsourced, the service is appropriate and risks present to product safety, quality or legality have been evaluated to ensure effective controls are in place.

• 3.8.1 Is there a documented procedure for the approval and monitoring of suppliers of services?

  compliant

  nc minor

  nc major

  N/A

• 3.8.2 Is there a documented agreement with all suppliers of services defining expectations associated with risk associated with the services?

  compliant

  nc minor

  nc major

  N/A

• 3.9 TRACEABILITY- FUNDAMENTAL The site shall be able to trace and follow all raw materials through processing to the distribution of the finished product (packaging material) to the customer and vice versa.

• 3.9.1 Is there a traceability procedure established? Does the procedure cover tracing from raw materials to finish goods and vice versa?

  compliant

  nc minor

  nc major

  N/A

• 3.9.2 Is identification of product at all stages adequate to ensure traceability?

  compliant

  nc minor

  nc major

  N/A

• 3.9.3 Is there a system in place to ensure customer can identify product lot number for traceability?

  compliant

  nc minor

  nc major

  N/A

• 3.9.4 Has the system been tested and verified for traceability of all raw materials? Has traceability from raw material to finished product and vice versa been conducted? Is the test conducted at least annually?

  compliant

  nc minor

  nc major

  N/A

• 3.9.5 Does any reworked material maintain traceability?

  compliant

  nc minor

  nc major

  N/A

• 3.10 CUSTOMER FOCUS AND CONTRACT REVIEW- The company's senior management shall ensure that processes are in place to determine customer needs and expectations with regard to quality, safety and legality, and ensure these are fulfilled.

• 3.10.1 Are associates designated to communicate with customers to ensure needs and expectations are met? is the system effectiveness probed?

  compliant

  nc minor

  nc major

  N/A

• 3.10.2 Are customer needs documented and reviewed on a suitable frequency? Are changes to existing agreements or contracts agreed, documented and communicated to appropriate departments?

  compliant

  nc minor

  nc major

  N/A

• 3.10.3 Are customers performance criteria communicated to relevant staff? adhered and reviewed at appropriate intervals?

  compliant

  nc minor

  nc major

  N/A

• 3.11 COMPLAINT HANDLING- Customer complaints relating to product safety shall be effectively handled and information used to reduce complaint levels.

• 3.11.1 Are actions taken in a timely manner to effectively handle complaints and provide feedback? Trained staff? Records of corrective actions?

  compliant

  nc minor

  nc major

  N/A

• 3.11.2 Is customer complaint data analyzed? Is root cause analysis practiced where there has been a significant increase or repetition of a complaint type? Is this analysis available to relevant staff to prevent recurrence?

  compliant

  nc minor

  nc major

  N/A

• 3.12 MANAGEMENT OF PRODUCT WITHDRAWALS, AND INCIDENTS AND PRODUCT RECALLS- The site shall have systems in place to effectively manage any product withdrawals or returns from customers, incidents and product recalls in order to ensure that all potential risks to the quality and legality of products are controlled.

• 3.12.1 Are recalls or withdrawals carried out to a documented process with relevant key personnel identified, plan for customer notification if necessary, root cause and corrective actions to review for improvements?

  compliant

  nc minor

  nc major

  N/A

• 3.12.2 Can the recall/withdrawal procedure be conducted at any time? executing all steps in the process?

  compliant

  nc minor

  nc major

  N/A

• 3.12.3 Is there a designated manager responsible for ensuring root cause analysis is used to determine and implement preventive action and improvements?

  compliant

  nc minor

  nc major

  N/A

• 3.12.4 Have relevant staff been trained on the recall/withdrawal procedure? training records up-to-date? Reporting procedure in place?

  compliant

  nc minor

  nc major

  N/A

• 3.12.5 Are measures in place to prevent the release of product that may risk product safety and quality in the event of an incident?

  compliant

  nc minor

  nc major

  N/A

• 3.12.6 Is there a procedure in place to manage product recalls initiated by the brand owner or customer? Is key personnel identified? Communication plan in place to notify customers and when necessary regulatory bodies? Does the procedure include corrective actions and business recovery? review of recalls to conduct root cause analysis and implement appropriate improvements?

  compliant

  nc minor

  nc major

  N/A

• 3.12.7 Can recalled product be traced?

  compliant

  nc minor

  nc major

  N/A

• 3.12.8 Procedure is tested at a minimum once per year with results documented. Last test date? Percent of recovery? Time to complete? Evaluation for changes needed?

  compliant

  nc minor

  nc major

  N/A

SECTION 4 SITE STANDARDS

• Does this audit cover Section 4

  Yes

  No

  N/A

• 4.1 EXTERNAL STANDARDS- The site shall be of suitable size and construction, in a suitable location, and maintained to an appropriate standard to reduce the risk of contamination and facilitate the production of safe and legal products.

• 4.1.1 Is consideration given to activities and environment around plant that could have a negative impact on the quality of finished product? Are measures taken to prevent contamination of product?

  compliant

  nc minor

  nc major

  N/A

• 4.1.2 Are external areas maintained in good order? Grass mowed, no excessive vegetation? traffic routes suitably surfaced to prevent contamination?

  compliant

  nc minor

  nc major

  N/A

• 4.1.3 Is the building fabric maintained to prevent pest, water, contaminant entry? Potential entry points of same are appropriately sealed & secured?

  compliant

  nc minor

  nc major

  N/A

• 4.1.4 Is natural external drainage adequate? external drainage added if necessary? Are drains protected to avoid entry of pests?

  compliant

  nc minor

  nc major

  N/A

• 4.1.5 In the event of external storage of raw materials, are these protected to minimize risk of contamination?

  compliant

  nc minor

  nc major

  N/A

• 4.2 BUILDING FABRIC AND INTERIORS: RAW MATERIALS HANDLING, PREPARATION, PROCESSING, PACKING AND STORAGE AREAS- The internal site, buildings and facilities shall be suitable for the intended purpose. All utilities to and within the production and storage areas shall be designed, constructed, maintained and monitored to effectively control the risk of product contamination.

• 4.2.1 Are walls, floor, ceilings and pipe work cleaned and maintained in good order? (This includes suspended ceilings). Do they facilitate cleaning? Any dust on walls, pipes? Spiderwebs? Peeling paint, stained duct work?

  compliant

  nc minor

  nc major

  N/A

• 4.2.2 Are windows that constitute a risk of contamination to product protected against breakage?

  compliant

  nc minor

  nc major

  N/A

• 4.2.3 Are light bulbs, including insect trap lights, shatterproof or protected against breakage to prevent product contamination?

  compliant

  nc minor

  nc major

  N/A

• 4.2.4 Is adequate lighting provided to ensure a safe working environment? correct operation of processes? effective inspection of product? appropriate cleaning?

  compliant

  nc minor

  nc major

  N/A

• 4.2.5 Is ventilation adequate? Are ventilation filters on a cleaning schedule?Are records of service activity kept on file?

  compliant

  nc minor

  nc major

  N/A

• 4.3 UTILITIES- Product quality shall not be compromised by the location, construction and delivery of the utilities to and within the production and storage areas.

• 4.3.1. Does the site have a copy of the most current local water report ensuring water used in processing is potable or suitably treated to prevent contamination?

  compliant

  nc minor

  nc major

  N/A

• 4.3.2. Does the site have preventative measures to ensure air, compressed air and other gases that come into direct contact with product do not present risk to safety or quality? Do these measures comply with relevant legal regulations? Are filters specifications on file? Is there a PM program for filters? records of servicing?

  compliant

  nc minor

  nc major

  N/A

• 4.4 SECURITY- Product and process integrity shall be assured through appropriate site security provision.

• 4.4.1 Based on risk assessment, is the site adequately controlled for access and security to prevent deliberate attempt to inflict product contamination? Is there a documented procedure to assess and ensure product defense? Are assessments conducted at least annually?

  compliant

  nc minor

  nc major

  N/A

• 4.4.2 Is access to production and storage areas restricted to only authorized personnel? Is access to the site by employees, contractors and visitors controlled? Is there a visitor reporting system in place? Is personnel trained in site security procedures and encouraged to report or challenge unidentified or unknown visitors? Are training documents on file?

  compliant

  nc minor

  nc major

  N/A

• 4.4.3 Are external openings to storage tanks, silos and intake pipes secured to prevent unauthorized access?

  compliant

  nc minor

  nc major

  N/A

• 4.5 LAYOUT AND PRODUCT FLOW- Premises and plant shall be logically designed, constructed and maintained.

• 4.5.1 Is there a documented site plan for access points, travel routes, staff facilities, process flow and storage areas?

  compliant

  nc minor

  nc major

  N/A

• 4.5.2 Does the process flow provide elements to minimize the risk of contamination or damage to product?

  compliant

  nc minor

  nc major

  N/A

• 4.5.3 Is there sufficient working space and storage capacity for appropriate operation?

  compliant

  nc minor

  nc major

  N/A

• 4.5.4 Is there a designated walkway to allow access through production areas ensuring adequate segregation from materials?

  compliant

  nc minor

  nc major

  N/A

• 4.6 EQUIPMENT- Equipment shall be suitably designed for the intended purpose and shall be maintained and used so as to minimize the risk to product safety, legality and quality.

• 4.6.1 Is all equipment constructed from suitable materials allowing for cleaning and proper maintenance?

  compliant

  nc minor

  nc major

  N/A

• 4.6.2 Is new equipment properly specified before purchase?Tested and commissioned prior to use? Maintenance program established?

  compliant

  nc minor

  nc major

  N/A

• 4.7 MAINTENANCE- An effective maintenance program shall be in operation for plant and equipment to prevent contamination and reduce the potential for breakdowns.

• 4.7.1 Is there a documented maintenance program covering all production and plant equipment? Are records available?<br>

  compliant

  nc minor

  nc major

  N/A

• 4.7.2 Is there a documented procedure detailing the release of equipment to production after maintenance is performed? Are records of clearance on file?

  compliant

  nc minor

  nc major

  N/A

• 4.7.3 Are tools and other maintenance equipment cleared away after use and appropriately stored?

  compliant

  nc minor

  nc major

  N/A

• 4.7.4 Are temporary repairs used only in emergencies and when product is not at risk? Is there a specified timeframe for use? Is the process documented?

  compliant

  nc minor

  nc major

  N/A

• 4.7.5 Are Maintenance (Engineering) shops controlled to prevent contamination of products? If dept opens directly into production, are mat or tack pads in place and clean?

  compliant

  nc minor

  nc major

  N/A

• 4.7.6 Are contractors involved in maintenances or repair monitored by a staff member? Is this staff member responsible for their activities?

  compliant

  nc minor

  nc major

  N/A

• 4.8 HOUSEKEEPING AND CLEANING- FUNDAMENTAL Housekeeping and cleaning systems shall be in place which ensure that appropriate standards of hygiene are maintained and that risk of contamination to the product is minimized.

• 4.8.1 Are good standards of housekeeping maintained? Is a "clean as you go" policy practiced?

  compliant

  nc minor

  nc major

  N/A

• 4.8.2 Is there a documented cleaning procedure for buildings, equipment and vehicles? Do the the cleaning schedules and procedures include item/area to be cleaned? frequency? method? cleaning materials used?<br>

  compliant

  nc minor

  nc major

  N/A

• 4.8.3 Are cleaning chemicals adequate for purpose, clearly labeled and secured in close containers? Are janitor supplies kept segregated?

  compliant

  nc minor

  nc major

  N/A

• 4.9 PRODUCT CONTAMINATION CONTROL- All practicable steps shall be taken to identify, eliminate, avoid or minimize the risk of foreign body or chemical contamination.

• 4.9.1 GLASS, BRITTLE PLASTICS, CERAMICS AND SIMILAR MATERIALS CONTROL

• 4.9.1.1 Are glass and brittle plastics included in a risk assessment such as HACCP? Is there an inventory list of potential areas of risk? Is there a record of checks of condition of items? frequency? details of cleaning or replacing of items to minimize product contamination?

  compliant

  nc minor

  nc major

  N/A

• 4.9.1.2 Is there a documented breakage incident procedure? Is there a person in charge of the clean up and preventing further contamination? Is contaminated product inspected, segregated or disposed of? Are incidents recorded?

  compliant

  nc minor

  nc major

  N/A

• 4.9.2 SHARPS CONTROL

• 4.9.2.1 Is there a documented policy for the control of sharps?

  compliant

  nc minor

  nc major

  N/A

• 4.9.2.2 Are sharp blades, equipment and tools controlled to prevent product contamination?

  compliant

  nc minor

  nc major

  N/A

• 4.9.2.3 Are snap off blade knives forbidden on the production floor?

  compliant

  nc minor

  nc major

  N/A

• 4.9.3 CHEMICAL AND BIOLOGICAL CONTROL

• 4.9.3.1 Is there a documented chemical control program? Is there a chemical approval process in place? Are all chemical containers approprietly labeled?

  compliant

  nc minor

  nc major

  N/A

• 4.10 WASTE AND WASTE DISPOSAL- Suitable facilities shall be provided for the storage and disposal of process and other waste.

• 4.10.1 Is there a procedure for the removal of trademarked material by licensed contractors? Are destruction letters on file?

  compliant

  nc minor

  nc major

  N/A

• 4.10.2 Is waste properly sorted and segregated in designated containers?

  compliant

  nc minor

  nc major

  N/A

• 4.10.3 Are substandard trademarked materials rendered unusable through destructive process? Is there a record of disposed of materials?

  compliant

  nc minor

  nc major

  N/A

• 4.11 PEST CONTROL- The company shall be responsible for minimizing the risk of pest infestation on the site.

• 4.11.1 Is there a documented pest control program in place, covering all areas of the site?

  compliant

  nc minor

  nc major

  N/A

• 4.11.2. Is there a competent contractor under contract to perform pest control activities? Are records of pest control licenses on file?

  compliant

  nc minor

  nc major

  N/A

• 4.11.3 Does the site manage its own pest control program? If so, are controls in place to ensure trained and competent staff in charge, resources available to deal with infestation issues, access to specialist technical knowledge, legislation understanding and control of storage of pesticides?

  compliant

  nc minor

  nc major

  N/A

• 4.11.4 Is pest control equipment appropriately located and operational?

  compliant

  nc minor

  nc major

  N/A

• 4.11.5 Are immediate actions taken to eliminate hazard when infestation events occur? is product protected, inspected and released?

  compliant

  nc minor

  nc major

  N/A

• 4.11.6 Is there a pest control manual available? updated map outlining numbered pest control devices on location? Pest control products in use? Records of inspections and infestations?

  compliant

  nc minor

  nc major

  N/A

• 4.11.7 Are associates aware of reporting procedures in the event of pest activity?

  compliant

  nc minor

  nc major

  N/A

SECTION 5 PRODUCT AND PROCESS CONTROL

• Does this audit cover Section 5

  Yes

  No

  N/A

• 5.1 PRODUCT DEVELOPMENT- Documented product development or modification procedures shall be in place to ensure the production of safe and legal products to defined quality parameters.

• 5.1.1 Are customer requirements relating to design, development, specification, manufacture and distribution documented and agreed to? Are critical-use parameters such as barrier and testing parameters defined?

  compliant

  nc minor

  nc major

  N/A

• 5.1.2 Is there a documented procedure that defines when a production trial is required? Are trials and testing carried out validating that manufacturing processes are capable of producing a safe and legal product to the required quality?

  compliant

  nc minor

  nc major

  N/A

• 5.1.3 Is production carried out using defined operating conditions to ensure safe, legal products of the prescribed quality?

  compliant

  nc minor

  nc major

  N/A

• 5.1.4 Are technical product specifications prepared and agreed to, with customer or brand owner before the production process begins?

  compliant

  nc minor

  nc major

  N/A

• 5.1.5. Are samples indicating conformance retained for future reference?

  compliant

  nc minor

  nc major

  N/A

• 5.2 GRAPHIC DESIGN AND ARTWORK CONTROL- Artwork and all pre-press processes conducted by the site shall be managed to ensure loss of information and variation from customer specification is eliminated.

• 5.2.1 Is there a documented artwork management procedure covering information to be included in artwork, receipt of art files from the customer and verification of art and approval by the customer?

  compliant

  nc minor

  nc major

  N/A

• 5.2.2 Is there a formal acceptance and approval of final product concept and artwork by the customer? Is this procedure documented?

  compliant

  nc minor

  nc major

  N/A

• 5.2.3 Printing plates are properly stored?Are print trials carried out to ensure quality and print standards are consistent? Is there a procedure in place?

  compliant

  nc minor

  nc major

  N/A

• 5.2.4 Is printing equipment such as plates verified as correct to specification and artwork version? Fully traceable to customer's approved origination material?

  compliant

  nc minor

  nc major

  N/A

• 5.2.5 Are customer approved reference materials, artwork (proofs) and color standards used during print runs controlled to ensure preservation and return to appropriate storage after use? Is there a process to renew approved masters as necessary?

  compliant

  nc minor

  nc major

  N/A

• 5.2.6 Is there a documented procedure to manage artwork and specification changes? How are obsolete files managed?

  compliant

  nc minor

  nc major

  N/A

• 5.2.7 Are artwork files and approved masters in electronic form protected to prevent loss or tampering?

  compliant

  nc minor

  nc major

  N/A

• 5.3 PACKAGING PRINT CONTROL- Where packaging materials are printed or decorated, procedures shall be in place to ensure that the information is fully legible and correctly reproduced to the customer's specification and legal requirements.

• 5.3.1 Is there a risk assessment conducted to identify risk of loss of essential information and mixing of printed product? Are controls established?

  compliant

  nc minor

  nc major

  N/A

• 5.3.2 Are plates, cylinders, dies and print blankets appropriately stored?

  compliant

  nc minor

  nc major

  N/A

• 5.3.3 Is each print run approved against an agreed standard? Is this approval recorded?

  compliant

  nc minor

  nc major

  N/A

• 5.3.4 Is there a system in place to detect errors during a run? Can this errors be sorted from acceptable printed materials?

  compliant

  nc minor

  nc major

  N/A

• 5.3.5 Is there a procedure in place for mix prevention when running a combo job?

  compliant

  nc minor

  nc major

  N/A

• 5.3.6 Are samples of print runs retained with production records for an agreed period of time?

  compliant

  nc minor

  nc major

  N/A

• 5.3.7 Is there a procedure to account for any unused printed product and its disposition?

  compliant

  nc minor

  nc major

  N/A

• 5.3.8 Does lighting in inspection stations conform to accepted industry standards? How is this validated?

  compliant

  nc minor

  nc major

  N/A

• 5.4 PROCESS CONTROL- FUNDAMENTAL Documented procedures shall be in place to ensure effective quality assurance of operations throughout the process.

• 5.4.1. Are processes reviewed to identify manufacturing process control points that could affect product quality?

  compliant

  nc minor

  nc major

  N/A

• 5.4.2 Are process limits established for each manufacturing process control point? Are they documented and records kept?

  compliant

  nc minor

  nc major

  N/A

• 5.4.3 Can all materials used within a job be accounted for? Is there a ticket containing materials and specs on every job?

  compliant

  nc minor

  nc major

  N/A

• 5.4.4 Are documented process checks undertaken throughout the production run to ensure products conform to agreed quality specification?

  compliant

  nc minor

  nc major

  N/A

• 5.4.5 Is there a documented line clearance procedure to ensure that the line is clear of previous work and documents?

  compliant

  nc minor

  nc major

  N/A

• 5.4.6 Are changes to product, processing methods or equipment reviewed to re-establish process characteristics and validate product data? Is this review conducted to ensure product safety, legality and quality are maintained?

  compliant

  nc minor

  nc major

  N/A

• 5.5 CALIBRATION AND CONTROL OF MEASURING AND MONITORING DEVICES- Measuring equipment used to monitor manufacturing process control points, product quality and legality shall be calibrated.

• 5.5.1 Is there a calibration program in place covering all measuring equipment used to monitor product safety and quality?

  compliant

  nc minor

  nc major

  N/A

• 5.5.2 Is the calibration of items on the program traceable to a recognized national or international standard?

  compliant

  nc minor

  nc major

  N/A

• 5.5.3 Are corrective actions implemented and documented when measuring equipment is found to be out of calibration?

  compliant

  nc minor

  nc major

  N/A

• 5.6 PRODUCT INSPECTION, TESTING AND MEASURING- The company shall use appropriate documented procedures and facilities when undertaking or subcontracting inspection and analysis critical to product safety, legality and quality.

• 5.6.1 Are quality checks performed to demonstrate that finished product is within established tolerances and conforms to legal requirements? Is the frequency of checks in accordance with industry-accepted practice and based on risk analysis?

  compliant

  nc minor

  nc major

  N/A

• 5.6.2. Has a hazard risk analysis been conducted to determine the need for in line testing equipment?

  compliant

  nc minor

  nc major

  N/A

• 5.6.3 Is there a process in place to verify in line testing equipment? Is accuracy specified?

  compliant

  nc minor

  nc major

  N/A

• 5.6.4. Are there procedures established for the operation, routine monitoring and testing of equipment used for inspection, testing and measurement?

  compliant

  nc minor

  nc major

  N/A

• 5.6.5 Are routine off line quality checks conducted at appropriate stages of production to ensure product is within agreed tolerances?

  compliant

  nc minor

  nc major

  N/A

• 5.6.6 Is there a procedure to ensure reliability of test results?

  compliant

  nc minor

  nc major

  N/A

• 5.6.7 When subcontracting analysis performed on product, has the subcontracted laboratory gained recognized accreditation?

  compliant

  nc minor

  nc major

  N/A

• 5.7 CONTROL OF NON-CONFORMING PRODUCT- The site shall ensure that out-of-specification product is clearly identified and quarantined.

• 5.7.1 Is there a documented procedure in place for the handling of non conforming product? Is the procedure understood by all personnel? Effective identification and designated area?

  compliant

  nc minor

  nc major

  N/A

• 5.7.2 Is non-conforming material assessed and decision taken to reject, accept by concession or authorize to be reworked or put to alternative use? Is the decision and reason documented?

  compliant

  nc minor

  nc major

  N/A

• 5.7.3 Are corrective actions, root cause analysis and preventive actions implemented to avoid recurrence? Are actions taken documented?

  compliant

  nc minor

  nc major

  N/A

• 5.8 INCOMING GOODS- Incoming goods shall be appropriately checked for contents, packaging integrity and potential contamination.

• 5.8.1 Is there a procedure in place for the inspection of incoming raw materials and intermediate products? Are products verified against purchase order, delivery note and/or product specifications?

  compliant

  nc minor

  nc major

  N/A

• 5.8.2 Is FIFO system in place to ensure stock rotation of goods in storage?

  compliant

  nc minor

  nc major

  N/A

• 5.9 STORAGE OF ALL MATERIALS AND INTERMEDIATE AND FINISHED PRODUCTS- The risk of contamination of raw materials and finished products shall be minimized while in storage.

• 5.9.1 Are all materials, work in process and product, protected from contamination during storage?

  compliant

  nc minor

  nc major

  N/A

• 5.9.2 Is all storage, including off-site, controlled to protect product from contamination?

  compliant

  nc minor

  nc major

  N/A

• 5.9.3 Is there a chemical control program in place to minimize the risk of hazardous chemicals to product quality and legality?

  compliant

  nc minor

  nc major

  N/A

• 5.9.4 Is material intended for recycling appropriately protected against contamination hazards?

  compliant

  nc minor

  nc major

  N/A

• 5.10 DISPATCH AND TRANSPORT- The dispatch and transport of finished products shall be undertaken in a manner that minimizes the risk of contamination or malicious intervention and maintains product quality and legality.

• 5.10.1 Are all products and materials protected during transit and distribution by external packaging or transported under conditions to protect them from contamination?

  compliant

  nc minor

  nc major

  N/A

• 5.10.2 Are pallets checked? Is there a process to discard damaged, contaminated or unacceptable pallets? Are wooden pallets dry, clean and free from damage and contamination?

  compliant

  nc minor

  nc major

  N/A

• 5.10.3 Is there an inspection process for company owned vehicles?

  compliant

  nc minor

  nc major

  N/A

• 5.10.4 Is there documentation of third-party carriers agreed terms and conditions protecting product from contamination? When not possible, is the packaging adequate to protect the product against damage, contamination hazards, taint and odor during transit?

  compliant

  nc minor

  nc major

  N/A

• 5.10.5 Is access to the site for carrier drivers controlled? Are facilities provided to negate the need to enter storage or production areas?

  compliant

  nc minor

  nc major

  N/A

SECTION 6 PERSONNEL

• Does this audit cover Section 6

  Yes

  No

  N/A

• 6.1 TRAINING AND COMPETENCE: RAW MATERIALS HANDLING, PREPARATION, PROCESSING, PACKING AND STORAGE AREAS- FUNDAMENTAL The company shall ensure that all employees are adequately trained, instructed and supervised commensurate with their activity and are competent to undertake their job role.

• 6.1.1 Are all personnel appropriately trained prior to commencing work and adequately supervised? This includes temporary associates.

  compliant

  nc minor

  nc major

  N/A

• 6.1.2 Are personnel performing activities related to product safety, quality and legality suitably trained and competent to carry out the work? this includes personnel performing activities such as product inspection, testing and measuring, calibration, printed packaging controls and other operatives at manufacturing process control points.

  compliant

  nc minor

  nc major

  N/A

• 6.1.3 Is there a review of competency of staff and relevant training updates? are training records maintained?

  compliant

  nc minor

  nc major

  N/A

• 6.1.4 Are training records containing name of trainee, date and duration of training, title or course contents and training provider available?

  compliant

  nc minor

  nc major

  N/A

• 6.1.5 Is there a documented training program covering the training needs of personnel?

  compliant

  nc minor

  nc major

  N/A

• 6.2 PERSONAL HYGIENE: RAW MATERIALS HANDLING, PREPARATION, PROCESSING, PACKING AND STORAGE AREAS- The company's personal hygiene standards shall be developed to minimize the risk of product contamination from personnel. These standards shall be appropriate to the products produced and be adopted by all personnel, including agency-supplied staff, contractors and visitors to the production facility.

• 6.2.1 Are the requirements for personal hygiene determined based on risk, documented and communicated to all personnel? Do this requirements include hand washing and the wearing of jewelry, including wristwatches?

  compliant

  nc minor

  nc major

  N/A

• 6.2.2 Are personal items and belongings not taken into production areas unless permitted by management? Does this include mobile phones?

  compliant

  nc minor

  nc major

  N/A

• 6.3 STAFF FACILITIES- Staff facilities shall be sufficient to accommodate the required number of personnel and shall be designed and operated to minimize the risk of product contamination. Such facilities shall be kept in a good and clean condition.

• 6.3.1 Eating of any type of food including confectionary items, chewing gum or tobacco, drinking and smoking is not allowed in lockers, changing rooms or any non-designated areas?

  compliant

  nc minor

  nc major

  N/A

• 6.3.2 Are suitable and sufficient hand washing facilities available to enable cleaning of hands before and during work as required? Sufficient quantity of water at suitable temperature? Unscented liquid soap? Adequate hand drying? Signs to prompt use?

  compliant

  nc minor

  nc major

  N/A

• 6.3.3 Are toilets precluded from opening directly into storage, processing or production areas to prevent contamination of product? Sufficient and suitable hand washing facilities available?

  compliant

  nc minor

  nc major

  N/A

• 6.3.4 Are visitors and contractors made aware of facility hygiene policy?

  compliant

  nc minor

  nc major

  N/A

• 6.3.5 Eating of any type of food including confectionary items, chewing gum or tobacco, drinking and smoking is not allowed in production and storage or any non-designated areas?

  compliant

  nc minor

  nc major

  N/A

• 6.3.6 Is drinking of unflavored water only allowed in unbreakable, spill proof lidded containers or disposable conical cups in designated production areas, away from equipment?

  compliant

  nc minor

  nc major

  N/A

• 6.4 PROTECTIVE CLOTHING- Appropriate protective clothing shall be worn in production and storage areas to minimize the risk of production contamination. The risk of product contamination from clothing, hair or personal items shall be minimized.

• 6.4.1 Based on risk assessment, does personal clothing worn adhere to provided guideline to prevent contamination risk of product? (If risk assessment is used to claim exemption on this clause, a documented FMEA must be available for review.)

  compliant

  nc minor

  nc major

  N/A

• 6.4.2 Has communication been conducted regarding risk assessment on protective clothing to employees when relevant?

  compliant

  nc minor

  nc major

  N/A

• 6.4.3 Is clothing worn adequately clean? Is change of clothing available when required?

  compliant

  nc minor

  nc major

  N/A

• 6.4.4 Where protective clothing or uniforms are provided, are clean and dirty clothing segregated to prevent cross contamination?

  compliant

  nc minor

  nc major

  N/A

• 6.4.5 Is disposable clothing controlled to avoid product contamination?

  compliant

  nc minor

  nc major

  N/A

FINDINGS & SCORING

• Number of Minor findings

• Number of major findings

• Number of Critical Findings

Critical Findings

• Clause #

• Critical finding description with pictures of non conformance

• Add media

  Media

REVIEW & SIGN-OFF

• Auditor Name

  Sign

• Auditor Name

  Sign

• Manager Name

  Sign

• Manager Name

  Sign

• Manager Name

  Sign

• Quality Manager (if needed)

  Sign

• General Manager (if needed)

  Sign