PFMEA - Minor Non-Conformance for field left blank

Ac101118

Starting to get Involved
#1
Hello Cove,

We are currently going through our IATF surveillance audit. The auditor just wrote us a minor non-conformance because he found a PFMEA that did not have "None" written under recommended actions, the box was just blank. Per the auditor this is required per AIAG. The customer in question does not require us to use AIAG nor do their CSRs require the word "None" to be used to show that actions were considered. Is this something I should argue or should I just take it on the chin?
 
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Zero_yield

"You can observe a lot by just watching."
#3
Devil's advocate from a medical device QA person: N/Aing empty boxes is a part of good documentation practices and data integrity principles.

However, the fact that I'm insinuating one side is the devil should give some hint of what I think of that as a nonconformance. Opportunity for improvement? Sure, maybe, I guess.

But my understanding of why you should avoid empty spaces was to avoid someone making unapproved / fraudulent changes to raw data (at least on the med dev side of things). A PFMEA isn't exactly my definition of "raw data". Do you have some kind of final / approved / protected version of the PFMEA (for example, an electronically signed PDF or a version in a document management system)? You might be able to argue that you have electronic controls to prevent unapproved changes to the PFMEA, so the risk of an empty box is mitigated.
 

Bev D

Heretical Statistician
Leader
Super Moderator
#4
Zero Yield has a point - used in many industries especially those that are highly regulated.
Of course it’s silly and of no real protective value but it’s common…
 

Tidge

Trusted Information Resource
#5
If the document was approved with blank cells, and blank cells are not forbidden by practice, then the most serious auditor feedback I would tolerate is an "opportunity for improvement".

The time to care about blanks not labeled as "N/A" is on forms that are required to be filled out.
 
#6
Low hanging fruit! Did they actually check the process compared to the PFMEA? Did they audit the controls? Are you making defects despite the PFMEA? Did they check? How about the correct filling of the first 3 or 4 columns? No? Complain to the CB management for ineffective audits!
 

Sidney Vianna

Post Responsibly
Leader
Admin
#7
Devil's advocate from a medical device QA person: N/Aing empty boxes is a part of good documentation practices and data integrity principles.

However, the fact that I'm insinuating one side is the devil should give some hint of what I think of that as a nonconformance. Opportunity for improvement? Sure, maybe, I guess.
Discipline towards data integrity is definitely a trait of good corporate culture. However, if a CB auditor reports a single, isolated case of a blank form-field as a systemic problem, without providing additional evidence that the organization has a lax-approaching-ineffective towards data recording, s/he (the CB auditor) is being lazy and/or incompetent and/or stupid.

If the registrant wants to get picky and technical against this NC, just pay close attention what requirement this "violation" is going to be reported against. According to the OP
Per the auditor this is required per AIAG
Was the AIAG ever mentioned in the audit plan as part of the audit criteria? What EXACT (granularity is critical) AIAG document? Paragraph? For the 107 millionth time in this Forum: WITHOUT A VALID, RELEVANT REQUIREMENT, THERE SHALL BE NO NONCONFORMITY.
 

jmech

Trusted Information Resource
#8
Was the AIAG ever mentioned in the audit plan as part of the audit criteria? What EXACT (granularity is critical) AIAG document? Paragraph? For the 107 millionth time in this Forum: WITHOUT A VALID, RELEVANT REQUIREMENT, THERE SHALL BE NO NONCONFORMITY.
:applause:
 

Sebastian

Trusted Information Resource
#9
If empty cell was single case and other were "none", it was interesting.
Maybe somebody forget to put there something more valuable than "None".
There is alternative scenario, that all cells were empty and auditor downgraded finding.

IATF 16949 does not require using AIAG FMEA manual.
Customer does not require using AIAG FMEA manual.
Question - What methodology do you use for manufacturing process risk analysis?
Brief answer - AIAG.
So, NC was raised against internal, organizational requirement.

Write own procedure for PFMEA.
Pick from AIAG manual only the items you want.
Write - empty field in "Recommended action" sections are acceptable and that's it.
 

Enghabashy

Quite Involved in Discussions
#10
*There’s no added value ; if RPN or SOD is over criteria of acceptance ; hence there’s issuance of recommendation / recommended actions to reduce –hence the cell will be filled – the issuing recommendations/ recommend actions are not mandatory ; otherwise it could be indicated by choice : yes / no ‘ I see when any audited face this type of NCs; he is lucky ; the auditor may capture serious one if he didn’t face this easy one; therefore I see it's very good minor NC ;

*the IATF auditor has huge tasks & huge documentations which should be submitted & evaluated also ; let this duties are more easy for the both “for you & for your auditor also “ ; hence you have very good chance to find fantastic root causes & effective corrective actions / action plan, --- , nothing serious of this finding ‘ it’s out of customer Req. & products received ;

*you can accept this type of NCs ; you can get profit as gain the satisfaction of your auditor also ; he is one of your interested party ; lets him to be happy.
 
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