Title Page
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Supplier Name
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Supplier Code
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Address
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E-mail
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Telephone
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New Supplier
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Previous Audit Date
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Sanipex Auditor (s)
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Supplier representative
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Conducted on
Audit Summary
Positive points
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Improvement Areas
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Comments
General- Control Systems
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1. Rate the Suppliers internal Audit process? <br>Process should be in place, frequency and scope clearly detailed. <br>Review Supplier Audit Schedule for overdue items.
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2. How comprehensive are the available Quality Standards? <br>Should be comprehensive and available at every inspection point, are operators/inspectors aware of the content?
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3. Rate the training that personnel are given for their assigned function?<br>Is a training matrix available? Are training records kept, up to date and assessed? Is competency Proven before sign off?
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4. Rate the Suppliers Planned Preventive Maintenance Schedule?<br>Does it include all machinery, tools and auxiliary equipment?
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5. How strong are the suppliers change management/change controls?<br>Changes to manufacturing processes, plant relocation, documentation changes and approval, drawing changes and approval process. Do they include Customer notification and approval requirements?
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6. Rate the suppliers ability to demonstrate product performance claims?<br>Are tests carried out in-house or independent labs? <br>Does it meet recognized standards I.E. international Standards BSI etc
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7. If tests are carried out in-house, rate the supplier testing facility<br>Is it used regularly and maintained to test products? Does it have adequate equipment/ testing machines? Are those equipment calibrated? <br>
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8. Rate the suppliers procedure for handling Non-Conformances Report (NCRs)?<br>Is each NCR assigned a unique ref to aid traceability?<br>Is a tracking sheet used to monitor responses?
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9. Rate suppliers general regulation knowledge<br>Does the supplier know the scope of the regulation applicable on the product? Is there a regulatory survey? Are the standards/regulations kept up to date? <br>
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10. Is there a control of technical documentation?<br>Technical documents are available for each product and are up to date according to clients specification and regulatory changes? Record of technical documentation is available and followed up? <br>
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11. Rate the suppliers process of crisis and claim management<br>Is there a procedure for claim management? Are customer claims kept in record? How is the suppliers reactivity and proactivity to claims/cases raised by the client? <br>
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12. Does the supplier use a recognised Problem Solving Method, such as 8D, 5WHY, Ishakawa, Taguchi …?<br>Review a sample of Supplier's corrective actions, Check effectiveness of problem solving with quality monitoring and check control plan has been updated.
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13. Rate the suppliers process of incorporating learning's from field feedback into their CI activity?<br>Improved product design, improved processes
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14. Rate the suppliers capability to trace product end to end?<br>Can the supplier demonstrate effective traceability on an item?
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15. Rate the Process Flow Diagram<br>Does it clearly show how the product is made? Are all inspection points identified?
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16. Does the control plan include all quality assurance elements?<br>Product, process, key characteristics, inspections, parameter checks and set-up checks.<br>Is it Signed off by Key Stakeholders?
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17. Rate the suppliers advanced quality planning process for product development and change.<br> PPAP, AQP, FMEA, Product Approval present and evidence available
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18. Rate the Process Failure Mode Effects Analysis that has been performed? Are the corrective actions documented, implemented and effective?<br>Applicable if Sanipex has requested a Process FMEA. Check that FMEA indices are reviewed and updated on a regular basis
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19. Rate the suppliers capability to monitor process effectiveness and implement changes for improvement?<br>Use of SPC, process capability studies, kaizen events.
Purchasing - Supplier Selection & Ordering
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20. Rate how effective this suppliers process is in selecting, vetting and approving their sub-suppliers?<br>Is there a formal process for selection & approval eg, audit, monitoring process?
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21. Rate the suppliers control of approved sub-suppliers lists for all components, materials and services? <br>Is there an approved supplier list?<br>How is the performance of these Sub Suppliers monitored and evaluated?
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22. Rate the suppliers process for effective correction & Improvement activities within sub-suppliers?<br>Eg, rejection notes, 8D report etc.<br>Also check the criteria and responsiveness of sub-suppliers in case of customer complaints, Sub-supplier corrective action requests.Does this supplier instigate a CI Culture within its own supply chain?
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23. How clearly does the supplier express product requirements in their Purchase Orders?<br>Such as: material specifications, important dimensions and tolerances, restricted substances, Shelf Life Etc.
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24. Have all purchased raw materials been approved by the supplier using a formal process.<br>Check Initial Samples reports for each component and material?
Goods In & Raw Materials
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25. How comprehensive are the available SOPs at GI & Raw Mat. Storage? (Standard Operating procedures) <br>These should detail, who, where & What happens.<br>Reviewing the process does this accurately reflect what really happens?<br>
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26. How comprehensive are the inspection instructions? <br> Are there visual aids or prompts in place to highlight critical features or processes to the operator/inspector? <br>Are these readily available at every inspection point?
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27. Rate the storage, indentification and traceability of raw materials<br>Should be stored in a dry clean area away from risk of damage<br>How well is Shelf Life Controlled & managed?
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28. Rate the controls for identifying & segregating non-conforming product from good product.<br>Are there any defined quarantined areas/?<br>Are there any potentials for mixing up product? <br>In automated processes does reject product pass over good stock?
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29. Rate the completion, storage and retention of key product, process & inspection records.<br>Records should be complete and legible - have any corrections been signed and dated?<br>Are the records stored for an appropriate length of time?
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30. Rate the Inbound inspections performed by the supplier? Are they according to the Control Plan?<br>Have all critical raw materials been identified?
Production- Manufacturing, Inspection & Packaging
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30. Rate the work areas for identification, Cleanliness, Organisation & Lighting.<br>Is the Area well lit and well maintained.
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31. Rate the Key Performance Indicators that are in use?<br>Safety, quality, delivery, cost, people and environment
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32. How comprehensive are the available SOPs in the manufacturing process? (Standard Operating procedures) <br>Should also be available at every inspection point
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33. Rate the suppliers formal start-up/set-up procedure.<br>First part should be approved. In case of a long stoppage in operations, start-up procedure should be applied
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34. Rate the availability of operating and inspection instructions at the point of use, and operators awareness of them.<br>Check that they are in conformance with Product/Process Control Plan. Do they adequately detail how to perform the operations and what to inspect? Are they Comprehensive Enough?
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35. Rate the identification, traceability, control & handling of materials, WIP & Finished Product. <br>Does this align with the process flow diagram?<br>Is there any Potential for Mix-up?
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36. Rate the control of master samples - including usage, availability and correct storage.<br>Applicable if Sanipex has requested it.
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37. Rate the process for root cause analysis and subsequent corrective action of rejects<br>Is there an established 'non conformity' process in use
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38. Rate the process for root cause analysis and subsequent corrective action of rejects<br>Is there an established 'non conformity' process in use
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39 Rate calibration of measuring equipment.<br>Procedure for routine calibration<br>Are there any Out of calibration Items?<br>Are there any instruments Missing?
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40. Rate packaging effectiveness for protecting the product<br>Have Packaging trials been conducted?<br>Is it already in use and proven Historically?<br>Is it suitable for the Sanipex W/H & Distribution systems?<br>Moisture, Dirt, Damage, Heat, racking, lifting weight, stack height
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41. Rate the inspection approach with respect to protecting the customer i.e. Sanipex.<br>Does it appropriately detect all potential Failure Modes?<br>Does it Address Previous/known product issues seen in NCR's or Field Issues?
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42. Is the Frequency/Amount of Inspection Appropriate for the type and level of Product Being Manufactured?<br>Are there any Safety Critical or Hazardous Aspects?<br>Is 100% inspection needed or feasible?
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43. How closely does the Control Plan follow the actual process. <br>Do the operators know what to do in case of O.O.S?<br>who is responsible, When, Where, How, How often?
Warehousing - Storage & Despatch
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44. Rate the process to monitor incoming /WIP /finished goods inventory? <br>How good is the Stock Rotation System? <br>Look for empty shelves or an excess of one particular item & investigate further, does the system figure match?
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45. Rate the storage of finished goods <br>Should be stored in a dry clean area away from any risk of damage & contamination.
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46. Does the supplier respect the validity dates for perishable items?<br>Adhesives, sealants, paints/lacquers, process aids.<br>Could these have a detrimental effect to product performance if out of date?
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47. Rate the identification of finished goods according to Sanipex requirements?<br>Is there any potential for product mix-ups?<br>How robust is the traceability and labelling of items?
