NC on API Q2

ng yen ling

Currently i having some NC raise for the API Q2 and need help to reply to the NC as describe below. We have reply as follow by the auditor come back with the following question
Requirement - MS Standard API Spec Q2 1st Ed


Description The organization shall determine legal and other applicable requirements.
Product Specification


Objective Evidence Quality Procedure SP 5.1 Revision 002 Contract Review Checklist QPF 5.1-F 003A Job Nob: S 8571
Nonconformance/Concern Description Legal and Other applicable Requirements are not being documented as being reviewed as part of the Contract review Checklist. In each of the Checklist as presented the Item No 6 Legal and Other applicable items is marked as NO.

Root Cause Analysis

Personnel was under the impression that Contract Review Checklist items are to be checked only upon customer's request for Job No: S8571.

Contract Review Checklist for Job No: S8571 was updated accordingly.

Corrective Action(s)
Some jobs were sampled to check if contract review checklists were correctly completed and it was found to be done correctly.

API response

Please explain the control you have in place and/or how you have improved the related process to eliminate the cause and to prevent recurrence of the issue.

Anyone can please assist how to reply to the API? Thanks!


Trusted Information Resource
If they accept your root cause "Personnel was under the impression that...", then they are asking for some change(s) that will eliminate that root cause, and/or that will add a control to prevent that root cause from resulting in a recurrence.

So, possible change examples might include:
  • (root cause) Adding a requirement to the process for mandatory training on the checklist for relevant personnel, with specific emphasis on completing "Legal and Other applicable Requirements"
  • (root cause) Adding explanatory language to the checklist form stating how it is required to fill out that checklist section
  • (control) Adding a process step for someone to review & approve the completed checklist with a signature, where the review includes making sure that that "Legal and Other applicable Requirements" is filled out properly.

Ajit Basrur

Currently i having some NC raise for the API Q2 and need help to reply to the NC as describe below. We have reply as follow by the auditor come back with the following question

I have deleted your duplicate post. Please do not post in multiple forums

lanley liao

Lingli Liao
Hi, In fact. The API hopes that you can find out the gap in your management system. the key point for solving this problem is to modify your documented procedures related to contract review. you shall take into consideration three aspects: planning——implement——check.
In planning, you know whether have corresponding rules for this contract control. if yes, then these rules whether with operability; if no, then modified these rules and organized training. In an implementation, some rules we have prepared and employees are not aware of these rules or not understand, then you can organize training for these employees. if they know these rules, not abide by one to do some work. then you need to analyze this reason from four aspects: accountability whether it is clear? capability whether it is enough? sources whether it is sufficient? the extent of implement whether it is enough? In the end, you can know the reason from checking control requirements. The supervise of work is not done well. and i hope it can help you.
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