[RFE COPY] EB2678 ISA Audit Preparation Gap Analysis_Globe

Detailed Compliance Gap Analysis to EB Spec. 2678P NAV15, NAV16, NAV17, NAV20

Category

Checklist Questions

Quality Manual Section Name and Number Section 8.2.1 Customer Communication

Related Procedure Name and Number Procedure P-010 Rev. A

Compliance Description

Suggested Audit Interview Question

OQE to Request

Gaps in the Quality Manual

Supplier Information

Customer

1. Does the supplier have a process for handling customer feedback, including complaints?

The supplier has a process in place for handling customer feedback and complaints.

What is your process for handling customer feedback and complaints?

Customer feedback process

No specific mention of handling process for customer feedback.

Section 8.2.1, Define feedback handling process.

Feedback

documentatio n

Customer

2. Are customer feedback records maintained and reviewed periodically?

Section 8.2.1 Customer Communication

Procedure P-010 Rev. A

Customer feedback records are maintained and periodically reviewed to ensure quality.

How often are customer feedback records reviewed?

Customer feedback records

No specific mention of periodic review of feedback records. No specific mention of documented process for resolving complaints. No specific mention of continual improvement process documentation. No specific mention of using performance metrics to identify areas for improvement.

Section 8.2.1, Define periodic review process for feedback records.

Feedback

Customer

3. Is there a documented process for resolving customer complaints and ensuring corrective actions are taken?

Section 8.2.1 Customer Communication

Procedure P-010 Rev. A

There is a documented process for resolving complaints and implementing corrective actions.

Can you explain the process for resolving customer complaints and ensuring corrective actions are taken? Can you describe the process for continual improvement of the quality management system? How are performance metrics used to identify areas for improvement?

Complaint resolution and corrective action logs

Section 8.2.1, Define complaint resolution process.

Feedback

Continual Improvement

1. Is there a documented process for continual improvement of the quality management system?

Section 10.3 Continual Improvement

Procedure P-008 Rev. C

There is a documented process for continual improvement of the quality management system.

Continual improvement process documentatio n Performance metrics and analysis reports

Section 10.3, Define continual improvement process documentation.

Continual Improvement

2. Are performance metrics used to identify areas for improvement?

Section 10.3 Continual Improvement

Procedure P-008 Rev. C

Performance metrics are used to identify areas for improvement.

Section 10.3, Use performance metrics to identify areas for improvement.

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