Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number Section 8.5 Production and Service Provision
Related Procedure Name and Number Procedure P-022 Rev. E
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
General Workmanship/ Quality Practices
1. Does the supplier practice good workmanship habits with respect to product cleanliness? (i.e.: free from foreign objects, chips, burrs, construction debris, etc.)
Outlines the standards for workmanship, particularly the cleanliness of products during manufacturing.
How do you maintain and monitor cleanliness during production processes?
Cleanliness guidelines, inspection records
Inconsistent cleanliness practices during manufacturing.
Refer to Section 8.5 of the Quality Manual. Implement and document clear cleanliness guidelines for all stages of production.
General Workmanship/ Quality Practices
2. Does the supplier have a documented system for maintaining system/component cleanliness integrity?
Section 8.5.4 Preservation
Procedure P-022 Rev. E
Stresses the importance of maintaining the integrity of systems/components through adequate preservation measures.
What systems do you have in place to ensure the cleanliness and integrity of components throughout production? What is the procedure number for your cleanliness/flushing process, and how was it approved by the purchaser? How do you ensure compliance with the sample testing requirements? Who conducts the sampling and how?
Preservation and maintenance records
Lack of documented system for maintaining cleanliness and integrity of components.
Refer to Section 8.5.4 of the Quality Manual. Implement a documented system to ensure the cleanliness and integrity of components.
General Workmanship/ Quality Practices
3. Does the supplier have a Purchaser approved cleanliness/flushing procedure? If Yes, Procedure #:
Section 8.5 Production and Service Provision
Procedure P-022 Rev. E
Stipulates the requirement for specific cleanliness procedures to be approved by the purchaser, ensuring that all processes meet cleanliness standards. Ensures that sample testing is conducted in accordance with the approved procedures, whether in-house or by an external agency.
Approved procedure
Lack of approved
Refer to Section 8.5 of the Quality Manual. Ensure all cleanliness procedures are approved by the purchaser and documented.
cleanliness/flushing procedures.
documentatio n, approval records
General Workmanship/ Quality Practices
4. Does the supplier comply with sample testing requirements of the approved procedure? Is sampling done in-house or performed by an outside agency?
Section 8.6 Release of Products and Services
Procedure P-022 Rev. E
Sampling procedure
Inconsistent sample testing procedures.
Refer to Section 8.6 of the Quality Manual. Implement and document consistent sample testing procedures, whether done in-house or by an external agency.
documentatio n, contracts with external agencies
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