Corrective Action for Nonconformity in ISO/TS 16949 Recertification Audit

R

ROOTS

Involved In Discussions
Dear All,

I seek help from anyone to give an idea about the minor Nonconformity observed during ISO/TS 16949 by an external auditor. The NC is as follows,

We are using a potting chemical for our product which requires minimum 24 hours of curing. This has been addressed in our drawing and control plan also. We are producing more than 400 nos. of products per day with potting and during the audit, auditor asked how the time is controlled for curing? We said, this is only a manual control and the products produced today will be dispatched tomorrow after 24 hours. But the Auditor question is "for first manufactured product and last manufacturerd product in a day (400 nos.), there would be a time difference and how this is controlled"? (i.e. if the first product is potted at morning 9.00AM means the last product is potted at evening 5.00PM). And he asked how the minimum duration of 24 hours is ensured? He asked to make some poka yoke. But we feel it is difficult to have a poka yoke there?.

Can anybody give a simple and effective solution to submit Corrective action.

I have also attached the Auditor observation sheet for easy reference.

Please help

Thanks
MP
 

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Raffy

Raffy

Quite Involved in Discussions
Hi Roots, :bigwave:
As a start for Correction of Immediate Action:
1. Document the curing time of 24 hours since it was stated from "Drawing. No. 61923, Part : Back-up alarm assembly ? requires potting to be cured for 24 hours minimum @ room temperature." You need to do what you document.
2. Check also other parts in your inventory which were not documented and cured for 24 hours as required by your procedures.
3. After checking, you need also to document those parts in your inventory the curing time of 24 hours.
Root Cause:
1. Define the root cause through 5Y or Fish Bone Analysis. and try to identify the escape point where and why did it happen.
Corrective Action:
1. Generate your Corrective Action based on the Root Cause you defined.
Hope this helps.
Best regards,
Raffy :cool:
 
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