[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

Related Procedure Name and Number Procedure P-008 Rev. C

Compliance Description

Suggested Audit Interview Question

OQE to Request

Gaps in the Quality Manual

Supplier Information

Continual Improvement

3. Are improvement initiatives tracked and reviewed for effectiveness?

Section 10.3 Continual Improvement

Improvement initiatives are tracked and reviewed for effectiveness.

How are improvement initiatives tracked and reviewed for effectiveness? How are employees encouraged to participate in continual improvement activities? How are the results of continual improvement activities communicated to stakeholders? Can you describe the process for selecting and approving suppliers?

Improvement initiative tracking logs Records of employee participation in improvement activities Communicatio n records of continual improvement results Supplier selection and approval process documentation

No specific mention of tracking and reviewing improvement initiatives. No specific mention of encouraging employee participation in continual improvement activities. No specific mention of communicating continual improvement results to stakeholders. No specific mention of supplier selection and approval process.

Section 10.3, Track and review improvement initiatives.

Continual Improvement

4. Are employees encouraged to participate in continual improvement activities?

Section 10.3 Continual Improvement

Procedure P-008 Rev. C

Employees are encouraged to participate in continual improvement activities.

Section 10.3, Encourage employee participation in continual improvement activities.

Continual Improvement

5. Are the results of continual improvement activities communicated to all relevant stakeholders?

Section 10.3 Continual Improvement

Procedure P-008 Rev. C

The results of continual improvement activities are communicated to all relevant stakeholders.

Section 10.3, Communicate continual improvement results to stakeholders.

Supplier Control

1. Is there a documented process for selecting and approving suppliers?

Section 8.4 Control of Externally Provided Processes, Products, and Services Section 8.4 Control of Externally Provided Processes, Products, and Services

Procedure P-009 Rev. B

There is a documented process for selecting and approving suppliers.

Section 8.4, Define supplier selection and approval process.

Supplier Control

2. Are suppliers evaluated and re-evaluated based on their ability to meet quality and delivery requirements?

Procedure P-009 Rev. B

Suppliers are evaluated and re-evaluated based on their ability to meet quality and delivery requirements.

How are suppliers evaluated and re-evaluated for quality and delivery performance?

Supplier evaluation and re-evaluation records

No specific mention of evaluation and re- evaluation criteria for suppliers.

Section 8.4, Define evaluation and re-evaluation criteria for suppliers.

29

Made with FlippingBook - Share PDF online