Supplier Site Assessment Audit

• Supplier Name

• Conducted on

  Date
• Location
  Address

1. Quality System Documentation

• Is there a formal written Quality Policy approved by the Managing Director or equivalent?

  Yes

  No

  N/A

• Is this policy implemented & understood through all levels of the organization?

  Yes

  No

  N/A

• Does the policy accept & include the principles of continuous improvement, customer satisfaction, prevention of defects rather than detection & 100% conformance to specification?

  Yes

  No

  N/A

• Is the supplier registered with ISO 9000 or TS 16949 if so how long?

  Yes

  No

  N/A

• Is there a business model or process map which defines the interrelationship between the business processes?

  Yes

  No

  N/A

• Comments / Observations / Recommendations

2. Management Responsibility

• Are organisational charts contained within the quality documentation?

  Yes

  No

  N/A

• Are responsibilities for particular activities delegated & defined?

  Yes

  No

  N/A

• Comments / Observations / Recommendations

3. Management Review

• Are reviews conducted regularly (at least annually?)

  Yes

  No

  N/A

• Are customer concerns reviewed?

  Yes

  No

  N/A

• Are reviews minuted with actions & timings for appropriate departments?

  Yes

  No

  N/A

• Are quantitative measures of quality performance reported & reviewed?

  Yes

  No

  N/A

• Are the results of internal audits reviewed?

  Yes

  No

  N/A

• Comments / Observations / Recommendations

4. Resource Management & Infrastructure

• Are training matrices available for all personnel affecting quality?

  Yes

  No

  N/A

• Have necessary competence levels been defined

  Yes

  No

  N/A

• Are training records appropriately maintained?

  Yes

  No

  N/A

• Is there a programme for preventative maintenance of production equipment?

  Yes

  No

  N/A

• Are housekeeping standards defined & responsibilities defined & areas audited?

  Yes

  No

  N/A

• Comments / Observations / Recommendations

• Is there a factory maintenance programme and/or procedure

  Yes

  No

  N/A

5. Product Realisation Planning

• Is there a documented process for this activity & is it being adhered to at the time of the audit

  Yes

  No

  N/A

• Are quality objectives and requirements defined for the product?

  Yes

  No

  N/A

• Are processes established and documented

  Yes

  No

  N/A

• Are necessary verification, validation and test activities defined for the product?

  Yes

  No

  N/A

• Is there evidence that the realisation process and the resulting product meet customer requirements?

  Yes

  No

  N/A

• Comments / Observations / Recommendations

6. Customer Related Processes

• Is there a documented process for this activity & is it being adhered to at the time of the audit?

  Yes

  No

  N/A

• Are customer requirements determined before the contract is progressed?

  Yes

  No

  N/A

• Are customer requirements reviewed and the results minuted?

  Yes

  No

  N/A

• Is manufacturing capacity reviewed prior to taking an order?

  Yes

  No

  N/A

• Is there a process defined for communicating with customers with regard to product information, contract details, customer feedback and customer complaints

  Yes

  No

  N/A

• Comments / Observations / Recommendations

7. Design Control

• Are design and development processes defined and controlled?

  Yes

  No

  N/A

• Are personnel carrying out the activities suitably qualified?

  Yes

  No

  N/A

• Are formal design reviews conducted and are there documented minutes?

  Yes

  No

  N/A

• Are design outputs verified against design inputs and are records retained of verification results?

  Yes

  No

  N/A

• Are design changes notified to the customer?

  Yes

  No

  N/A

• Comments / Observations / Recommendations

8. Purchasing

• Is there a defined process for this activity?

  Yes

  No

  N/A

• Is there a list of preferred suppliers and is it maintained

  Yes

  No

  N/A

• Do all purchase documents state requirements precisely?

  Yes

  No

  N/A

• Are the relevant quality standards referred to on purchase orders?

  Yes

  No

  N/A

• Are records kept of corrective and preventive actions taken by suppliers when requirements are not achieved?

  Yes

  No

  N/A

• Comments / Observations / Recommendations

9. CTL Seal Supplied Product

• Is there a defined process for this activity?

  Yes

  No

  N/A

• Is CTL Seal product verified and stored adequately?

  Yes

  No

  N/A

• Comments / Observations / Recommendations

10. Identification and Traceability

• Are there written procedures for this activity & are they being adhered to at the time of the audit?

  Yes

  No

  N/A

• Is raw material and in process material suitably identified?

  Yes

  No

  N/A

• Is the traceability of specified materials maintained?

  Yes

  No

  N/A

• Are finished goods identified?

  Yes

  No

  N/A

• Comments / Observations / Recommendations

11. Control of Production & Service Provision

• Are production stages controlled by route cards or by similar means of control?

  Yes

  No

  N/A

• Are production stages controlled by route cards or by similar means of control?

  Yes

  No

  N/A

• Where specified are products held until critical dimension and /or characteristics are checked & recorded including the use of SPC

  Yes

  No

  N/A

• Where applicable are the operations which cannot be verified by subsequent inspection & testing continually monitored?

  Yes

  No

  N/A

• Is there an adequate environment for all inspection checks?

  Yes

  No

  N/A

• Where appropriate are visual acceptance standards available at point of use

  Yes

  No

  N/A

• Is product final inspection performed & authorised & recorded

  Yes

  No

  N/A

• Comments / Observations / Recommendations

12. Measurement and Analysis

• Is there a defined process for this activity & is it being adhered to at the time of the audit?

  Yes

  No

  N/A

• Are control plans available as summaries of inspection & tests instructions?

  Yes

  No

  N/A

• Are there controlled inspection stamps and/or authorised signatures?

  Yes

  No

  N/A

• Are inspection & test records available & maintained?

  Yes

  No

  N/A

• Comments / Observations / Recommendations

• Are initial sample inspection reports compiled?

  Yes

  No

  N/A

• Is there a defined process for measuring customer satisfaction?<br><br><br>

  Yes

  No

  N/A

• Is there an action plan for the improvement of customer satisfaction?

  Yes

  No

  N/A

• Are all business processes clearly defined with measures of performance defined?

  Yes

  No

  N/A

• Do process performance measures indicate improving trends of performance?

  Yes

  No

  N/A

13. Control of Monitoring and Measuring devices

• Is there a defined process for this activity & is it being adhered to at the time of the audit

  Yes

  No

  N/A

• Are calibration methods clearly defined & traceable to national standards?

  Yes

  No

  N/A

• Are calibrations conducted against defined limits of error?

  Yes

  No

  N/A

• Do calibration schedules exist & are the calibration frequencies sufficient

  Yes

  No

  N/A

• Are calibration results recorded?

  Yes

  No

  N/A

• Comments / Observations / Recommendations

14. Control of Non Conforming Product

• Are there written procedures for this activity & are they being adhered to at the time of the audit

  Yes

  No

  N/A

• Is non-conforming product segregated & identified

  Yes

  No

  N/A

• Is the procedure for disposition of non-conforming product clearly defined & recorded?

  Yes

  No

  N/A

• Does the supplier monitor internal reject performance?

  Yes

  No

  N/A

• Are repaired or reworked products re-inspected before release?

  Yes

  No

  N/A

• Comments / Observations / Recommendations

15. Corrective & Preventive Action

• Are there written procedures for this activity & are they being adhered to at the time of the audit?

  Yes

  No

  N/A

• Are responsibilities & implementation dates for corrective & preventive actions assigned?

  Yes

  No

  N/A

• Are preventive actions implemented to ensure that concerns are not repeated?

  Yes

  No

  N/A

• Are corrective & preventive actions followed up by audits?

  Yes

  No

  N/A

• Is action taken to eliminate the causes of potential non-conformances i.e. FMEA, risk analysis etc.

  Yes

  No

  N/A

• Comments / Observations / Recommendations

16. Preservation of Product

• Is there adequate environmental protection in storage?

  Yes

  No

  N/A

• Is there adequate contamination protection in process?

  Yes

  No

  N/A

• Do in-house handling methods prevent damage?

  Yes

  No

  N/A

• Are all products in storage stock rotated?

  Yes

  No

  N/A

• Is shelf life known & adequately controlled on relevant products

  Yes

  No

  N/A

• Comments / Observations / Recommendations

• Are all jigs, fixtures & tooling adequately identified & stored

  Yes

  No

  N/A

17. Control of Records

• Is there a written process for this activity & is it being adhered to at the time of audit

  Yes

  No

  N/A

• Are there master lists for procedures, drawings, processes etc?

  Yes

  No

  N/A

• Are records held for a defined period and are there disposition procedures

  Yes

  No

  N/A

• Are records stored in a manner that prevents deterioration and are they easily accessible

  Yes

  No

  N/A

• Are IT records stored safely and supported with duplicates

  Yes

  No

  N/A

• Comments / Observations / Recommendations

18. Internal Quality Audit

• Is there a written process for this activity & is it being adhered to at the time of audit

  Yes

  No

  N/A

• Is there a timing plan for internal audits and is it adhered to

  Yes

  No

  N/A

• Are specific results recorded, corrective actions raised and implementation monitored?

  Yes

  No

  N/A

• Is the importance & status of process taken into account in the audit planning schedule?

  Yes

  No

  N/A

• Comments / Observations / Recommendations

19. Continual Improvement

• Is there a program to implement quality improvement techniques that includes manuals & guidelines

  Yes

  No

  N/A

• Has an action plan been developed for the continual improvement effort with a nominated co-ordinator?

  Yes

  No

  N/A

• Does the continuous improvement program include waste reduction, machine downtime reduction, process capability improvement & reduction in product & process variation?

  Yes

  No

  N/A

• Can the supplier provide documented evidence of recent improvements?

  Yes

  No

  N/A

• Comments / Observations / Recommendations

Audit Declaration

Assessment Completed By

• Name

• Position

• Signature

  Sign

• Date

  Date

Supplier Acknowledgement

• Name

• Position

• Signature

  Sign

• Date

  Date