Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20
Category
Checklist Questions
Quality Manual Section Name and Number
Related Procedure Name and Number
Compliance Description
Suggested Audit Interview Question
OQE to Request
Gaps in the Quality Manual
Supplier Information
Records 1. Is it stated in the supplier’s procedures that all OQE pertaining to supplied material must be retained for a period of 7 years after the completion of the last item of the
Section 7.5.3 Control of Documented Information
Procedure P- 022 Rev. E
Mandates the retention of all quality and compliance records for a minimum of 7 years to ensure traceability and accountability.
What are your procedures for retaining OQE for the required period?
Retention policies, sample retained documents
Lack of comprehensive retention procedures for OQE.
Refer to Section 7.5.3 of the Quality Manual. Implement and document procedures to ensure retention of OQE for the specified periods.
contract (purchase order) and shall be made available to the Purchaser within 36 hours upon request? For electronic parts and assemblies, this time of retention is extended to ten years. that test reports and/or other verification of conformance documents need to be signed and dated by the seller’s authorized representative? erasures or obliterations of information on Quality records are prohibited and that corrections must be made in ink by drawing a single line through the incorrect entry and be dated and initialed by authorized personnel? records made by the person who made the original entry, a supervisor, or person assigned by the supervisor? Is the original entry legible?
Records 2. Does the supplier understand
Section 7.5.3 Control of Documented Information
Procedure P- 022 Rev. E
Requires all critical documents, such as test reports and verification records, to be officially signed and dated by authorized personnel. Details the proper method for making corrections in quality records to maintain their integrity and traceability. Specifies that corrections to records must be made by authorized individuals and must maintain legibility to ensure traceability and integrity of records. Ensures all records are documented and annotated clearly and comprehensively to meet quality and regulatory requirements.
How do you manage and verify the signing and dating of test reports and
Signed test reports, verification documents
Inconsistent signing and dating of documents.
Refer to Section 7.5.3 of the Quality Manual. Ensure proper management and verification of document signing and dating. Refer to Section 7.5.3 of the Quality Manual. Implement and document procedures to ensure retention of OQE for the specified periods. Refer to Section 7.5.3 of the Quality Manual. Designate authorized personnel for record corrections and ensure the legibility of original entries. Refer to Section 7.5 of the Quality Manual. Establish
verification documents?
Records 3. Is the supplier aware that
Section 7.5.3 Control of Documented Information
Procedure P- 022 Rev. E
What procedures are in place to handle corrections in quality records?
Corrected records samples, correction policy
Lack of clear procedures for correcting quality records.
Records 4. Are corrections to official
Section 7.5.3 Control of Documented Information
Procedure P- 022 Rev. E
Who is authorized to make corrections to official records, and how do you ensure the original entries remain legible?
Corrected records, policy on record amendments
Inconsistent authorization for making corrections. Inadequate documentation and annotation of official records.
Records 5. Are official records
Section 7.5 Documented Information
Procedure P- 022 Rev. E
How are official records documented and
Sample of annotated records, documentation guidelines
documented or annotated satisfactorily?
clear guidelines for documenting and annotating records satisfactorily.
reviewed for satisfactory annotation?
8
Made with FlippingBook - Share PDF online