API Q1 9th Edition Surveillance Audit - Quality Policy

[Amanda W.]

Hello All,

Last week, we had our 1st Surveillance Audit after recertification. We only had two Minor Findings.

Objective Evidence for AAR 1:
Quality Policy was not updated after the Management Review.

Concern Description:
People that signed the QP was not current and one person on the QP was gone before the Management Review meeting. QP also does not have a date on the policy when posted.

Some background for this finding...our Quality Manager died very suddenly in the middle of 2020. He was my mentor. He taught me everything I know and he was very well respected throughout the company. I explained the circumstances to the auditor but, I do understand that the Quality Policy needs to be signed by the current QA Manager. I have inherited the position and I haven't wanted to replace his name with my own. I have no issues with that part of the finding, I understand that it needs to be changed. I came in the morning of the 2nd day of the audit and changed it, hoping that this would be downgraded to a concern. My question is, does the Quality Policy need a Revision Date and a Form Number? I looked at API Q1 4.1.2 and I cannot find anything stating that.

 

[jmech]

The quality policy is a document required by API Q1, so it is required to be controlled per Q1 4.4.3.

Identification of the "revision status" is required per 4.4.3 b. Revision date might not be strictly required by API Q1, but it can be helpful. For example, having top management sign your quality policy on the date of your management review can be a way to provide evidence that top management has reviewed the quality policy (as required by 6.5.1) and verified its suitability.

There is no requirement in Q1 to assign it a form number. The document needs to be identified, but it can simply be identified by the title "Quality Policy" without any form number.

 

[lanley liao]

Hi, Amanda,
The advice from Jmech was right so much!
The corresponding document related to this person change should be modified in accordance with your Document Control Procedure.
This question was also belongs to bullet c) of 5.11.2(MOC), because the QA manager is important to a job in your company.
This nonconformance exists a certain risk to your company.