Rapporto di Audit Copacker - Fornitori Materiali

• Fornitore/Copacker

• Audit Title

• Client / Site

• Prepared by

• Location
  Address

• Personnel

• Supplier:

• Date:

  Date

• Location:

Attendees

• Name:

• Company & Title:

General Information

• Group (updated data)

• Plant (updated data)

• Started in

• Factory area

• Employees

• Lines

• Products

• Output (b/d)

• Nr. of simultaneous productions (max)

• Warehouses

Warehouse

• TOT

• Covered

• Glass/PET

• Packaging Lines

• B&M dedicated lines

1. Quality Management System

• 1.1 ISO<br>- Has the Supplier a formal QMS?<br>- Is this system externally accredited? <br>- Is ISO 9000 implemented?<br>- Is the supplier externally accredited? If so, can we have a copy of the Certificate also a copy of the findings from the last Audit?

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• 1.2 Continuous improvement<br>- Is it part of the Supplier company culture?

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• 1.3 Document Control<br>Documents: are documented procedures established to define controls needed: <br>- to approve documents for adequacy prior to issue?<br>- to review and update as necessary and re-approve documents?<br>- to ensure that changes and current revision status of documents are identified?<br>- to ensure that relevant versions of applicable documents are available at points of use?<br>- to ensure that documents remain legible and readily identifiable?<br>- to ensure that documents of external origin are identified and their distribution controlled?<br>- to prevent the intended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose?

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• 1.4 Records<br>- Has the Supplier established and maintained records to provide evidence of conformity to Bacardi requirements?<br>- Has the Supplier established and maintained records demonstrating the effectiveness the quality management system operation?<br>- How are records gathered?<br>- Are records legible, readily identifiable and retrievable?<br>- How are records controlled for identification, storage, protection, retrieval, retention time and disposition?

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2. Management Commitment

• 2.1 Quality Management System<br>- How is top management involved in the implementation of the quality system?<br>- How is the integrity of the QMS maintained when changes are implemented? <br>- How are changes to QMS managed?<br>- Is the QMS reviewed? Frequency?<br>- How the effectiveness of the QMS is communicated to the company?<br>- Are QMS improvements identified and reviewed for effectiveness?

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• 2.2 Bacardi Requirements<br>- Have they been determined?<br>- Has the Supplier’s Management communicated the importance of meeting Bacardi’s and statutory and regulatory requirements to staff?<br>- How?<br>- How are customer requirements met?<br>- Is customer satisfaction an aim of the Supplier?

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• 2.3 Quality objectives<br>- Have they been established?<br>- How is management committed to providing resources to achieve objectives?<br>- How do they cascade to all relevant functions and levels within the company?<br>- Are they consistent with the quality policy?

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• 2.4 Quality policy<br>- Has one been established? Provide details (revision date, etc)<br>- Does it include a commitment to comply with governing requirements?<br>- Does it include a commitment to continual improvement of the effectiveness of the quality management system?<br>- Does it provide a framework to establish and review quality objectives?<br>- How has it been communicated throughout the Supplier’s organization?<br>- How often is it reviewed for suitability?

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• 2.5 QMS Management & Review<br>- Have corporate responsibilities and authority been defined? Organizational charts<br>- How management manages the QMS?

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3. Resource Management

• 3.1 General<br>Has the Supplier determined and provided resources to:<br>- implement, maintain and continually improve the effectiveness of the QMS?<br>- to improve customer satisfaction by meeting requirements?

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• 3.2 Human Resource Management<br>- How are personnel affecting product quality proved competent? How is competency demonstrated?<br>- Does training align with satisfying customer requirements? How is the training evaluated for effectiveness?<br>- Are appropriate training and competency records available and maintained?

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• 3.3 Infrastructure<br>- Have buildings, workspace, utilities, process equipment and support services been provided to fulfil Bacardi order requirements?<br>- Does the work environment provide clean and safe areas in which to operate?<br>- Is the infrastructure maintained effectively to achieve product conformity?

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• 3.4 HACCP<br>- Has HACCP program been implemented? <br>- Which Critical Control points have been determined ? <br>- How often are they being monitored?<br>- How often have they been challenged?

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4. Product Realisation

• 4.1 Planning of product realisation<br>Planning process for product realisation: how is it implemented?<br>Does it include: <br>- a project schedule and approval?<br>- quality objectives & requirements for the product linked to customer/market input?<br>- a resource plan specific to product?<br>- records of planned verification, validation, monitoring, inspection & testing, and acceptance criteria?

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• 4.2 - Are Bacardi requirements and references to its technical specification included in the planning of product realisation? <br>- Is there a process to assure the timely review, distribution and implementation of all Bacardi requirements and specifications?

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• 4.3 Customer - related processes<br>What process is used to determine Bacardi requirements:<br>- for delivery and post delivery activities?<br>- that are not stated by the customer but necessary for specified or intent use?<br>- statutory and regulatory requirements related to the product, including, safety and environmental regulations?

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• 4.4 Communication system<br>How is managed the communication with Bacardi of:<br>- product information?<br>- changes in raw materials or manufacturing processes at the Supplier’s that may change the supplied material or affect its utilisation by Bacardi?<br>- changes in the use of the supplied material at Bacardi that may affect the characteristics of the material?<br>- inquiries, contracts and order handling?<br>- Bacardi complaint and feedback?

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• 4.5 Design and development<br>- How is the design and development process implemented?<br>- How does the Supplier review, verify and validate the design and development in each stage?

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• 4.6 Inputs to design requirements<br>How does the Supplier identify, document and review these inputs, which include:<br>- product design output data?<br>- targets for product (quality, productivity, process capability, cost reliability, maintainability, durability)?<br>- Bacardi requirements?<br>- lessons learned?<br>- error proofing methods?<br>- use of special characteristics?<br>- preventive activities in design and process control?<br>- knowledge and application of legislation?<br>- results of internal/external audits including system certification?

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• 4.7 Changes<br>- How does the Supplier control and react to changes that have impact in product realization, including those initiated by supplier?<br>- How does the Supplier verify and identify changes or new product introduction when required by Bacardi? How are changes managed?

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• 4.8 Acceptance criteria<br>- What are the acceptance criteria for the product being developed?<br>- Are the criteria in line with Bacardi Global Quality Standards?

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• 4.9 Design outputs<br>How does the Supplier assure that the design outputs:<br>- meet the input requirements for design and development?<br>- provide appropriate information to purchasing, production & for service provision?<br>- contain or reference product acceptance criteria?<br>- specify the characteristics of the product that are essential for its safe and proper use?

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• 4.10 Manufacturing process design<br>Does it include:<br>- specifications and drawings?<br>- process flow chart?<br>- control plan?<br>- work instruction?<br>- process approval acceptance criteria?<br>- quality, reliability, maintainability and measurability data?<br>- error - proofing results?<br>- methods of rapid detection of non-conformities and feedback?

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• 4.11 Changes<br>- Is there evidence that the changes are reviewed, verified, validated, and approved before implementation?

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• 4.12 Purchasing process (by the Supplier)<br>- How is the purchasing process implemented?<br>- How does the Supplier ensure that its purchased products and materials conform to specified purchased requirements?

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• 4.13 Purchasing process for purchased product<br>- Does it ensure quality?<br>- Does it ensure that it meets requirements and specifications?<br>- Does it include special instructions for use, or equipment requirements?

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• 4.14 Evaluation of the Supplier’s suppliers<br>Which is the process to select, evaluate and re-evaluate the Supplier’s suppliers:<br>- criteria?<br>- records?

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• 4.15 Supplier performance<br>How does the Supplier monitor its own suppliers’ performance:<br>- quality performance of delivered parts?<br>- customer disruption including field returns?<br>- delivery schedule performance?<br>- non-conformance reports?

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• 4.16 Production and Service Provision<br>How does the Supplier plan and carry out production and service?<br>- availability of information that describe the characteristics of the product?<br>- availability of work instruction?<br>- use of suitable equipment?

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• 4.17 Control plans<br>Which control plans are in place for:<br>- controlling manufacturing process?<br>- monitoring and recording the results of control exercised over special characteristics?<br>- providing Bacardi required information?<br>- initiating the specified reaction plan when process becomes unstable or non-capable?

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• 4.18 Work instructions<br>- Are they available and accessible for use at the workstation for all employees having responsibilities for the operation of processes? (examples)

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• 4.19 - Process job set-ups? (Show record of job setups)

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• 4.20 - Key process equipment's: have they been defined?

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• 4.21 Preventive maintenance system<br>Is it in place? Does it include:<br>- planned maintenance activities?<br>- packaging and preservation of equipment, tooling and gauging?<br>- availability of replacement parts for key manufacturing parts?<br>- documenting, evaluating and improving maintenance objectives?<br>- methods to continually improve the effectiveness of its preventive system?

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• 4.22 Tooling and gauge design<br>- Is resource provided for fabrication and verification activities?

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• 4.23 Tooling management<br>Is a system established and maintained, including:<br>- maintenance and repair facilities and personnel?<br>- storage and recovery?<br>- set-ups?<br>- tool change programs for perishable tools?<br>- tool design modification documentation including engineering change level?<br>- tool modification and revision to the documentation, and tooling identification defining the status such as production disposal or repair?

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• 4.24 Scheduling<br>- How does the Supplier assure that production is scheduled to meet Bacardi requirements?

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• 4.25 Approvals<br>Has the Supplier established arrangements for all processes for production and service provision including, as applicable:<br>- defined criteria for review and approval of processes?<br>- approval of equipment and approval qualification of personnel?<br>- use of specific method and procedure?<br>- requirement and records?<br>- re-validation?

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• 4.26 Traceability<br>Describe:<br> - Supplier’s definition of lots;<br> - examples of records and control.<br>- Has the traceability system been tested?<br>- Frequency? (Check test date and results)

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• 4.27 Product preservation<br>How is the product preserved during the manufacturing process:<br>- identification, handling packaging, storage, protection and delivery?<br>- assessment of condition of product in stock at appropriate planned intervals to detect deterioration?<br>- handling of obsolete products?

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• 4.28 Inventory<br>- Is there an inventory management system in place? Describe.<br>- What method is used to optimise inventory turn over (FIFO?) and assure stock rotation?

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• 4.29 Control of monitoring and measuring devices<br>- How does the Supplier determine the monitoring and measurement to be undertaken? (records and examples)

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• 4.30 Measuring devices<br>How does the Supplier assure that measuring devices are:<br>- calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standard?<br>- adjusted or re-adjusted as necessary?<br>- identified to enable the calibration status to be determined?<br>- safeguarded from adjustment that would invalidate the measurement results?<br>- protected from damage and deterioration during handling and storage?

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• 4.31 Measurement validation<br>- How does the Supplier assess and record the validity of previous measuring results when equipment is found not to conform to requirement? <br>- Is corrective action taken each time?

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• 4.32 Analysis of results<br>- When necessary, are statistical studies conducted to analyse the variation present in the result of each type of measuring and test equipment system?

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• 4.33 Calibration records<br>Does the record of the calibration activity for all gauges, measuring and testing equipment include:<br>- equipment identification including the measurement standard against which the equipment is calibrated?<br>- revision following engineering changes?<br>- any out-of-specification reading as received for calibration/verification?<br>- assessment of impact of out of specification condition?<br>- statement of conformance to specification after calibration/verification?<br>- notification to customer if suspect product or material has been shipped?

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• 4.34 Supplier’s laboratories<br>Are the facilities:<br> - adequate?<br> - have qualified laboratory personnel conducting tests?<br> - capable of performing testing, calibration and services correctly?<br>- Is there traceability to relevant standard?<br>- Are records maintained?

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• 4.35 External laboratories<br>- Do the external / independent laboratory facilities used for inspection, test or calibration services have a defined laboratory scope that include accreditation to ISO 17025 or national equivalent?

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5. Measurement

• 5.1 Planning <br>Are measurement and monitoring activities needed to ensure conformity and achieve improvement:<br>- defined and available to Operators?<br>- consistent with customer requirements?<br>- planned with inspection criteria including inspection frequency and sample size?<br>- performed by trained individuals?<br>Provide examples to support that appropriate measurement methods are in use.

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• 5.2 Customer satisfaction<br>- Is customer satisfaction/dissatisfaction recorded and measured? <br>- If so, do the records include a root cause analysis and corrective actions or future improvements? <br>- Is there a trends analysis or any other analysis of complaint data?<br>- Are improvements made to the QMS as result of trends analysis?

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• 5.3 Internal audit <br>- Are internal audits performed by the supplier to validate the effectiveness of the QMS? Frequency?<br>- How are internal audit non-conformances and opportunities for improvement identified and tracked?<br>- Are corrective action plans created for internal audit nonconformance's?<br>- Are training records for internal auditors available?

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• 5.4 Measurement and monitoring of processes and of product <br>- How is determined which measurement and monitoring methods will be employed to ensure process requirements are met, with examples (i.e., KPI’s)?<br>- How is determined which measurement and monitoring methods will be employed to ensure product requirements are met, with examples?<br>- Provide examples of documented evidence to demonstrate that products conform to specifications<br>- Describe the acceptance criteria used

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• 5.5 Control of nonconformity <br>- What system is used to control non-conforming product identified internally?<br>- How is the non-conforming product returned from the customer controlled? <br>- Does the Supplier measure and analyse trends for non-conforming products? If so describe the frequency and types of analysis.<br>- Is there a system used to document nonconformance's reported by the customer?<br>- How are results on root cause and corrective actions reported to the customer in response to nonconformance reports?

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• 5.6 Analysis of data <br>Is there a structured system to collect and analyze data on the following:<br>- Conformance to customer requirements (specification)?<br>- Nonconformance to customer requirements?<br>- Process variability?<br>- Internal Key Performance Indicators ?<br>- Supplier’s Supplier Performance?<br>- Other (Specify)

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• 5.7 Improvement <br>Is there a structured system to identify continuous improvement opportunities?<br>Is there evidence of improvements made to the QMS as a result of analysis of the following data: <br>- Conformance to customer requirements (specification)?<br>- Nonconformance to customer requirements?<br>- Process Variability?<br>- Internal Key Performance Indicators?<br>- Supplier’s Supplier Performance?<br>- Other (Specify)

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• Details of Non-Conformances:

• Suggestions for improvement:

• Other comments:

• Report Issue Date:

  Date

• Report issued by:

  Sign