Internal Nonconformance procedure thoughts (AS9100)

Techster

Starting to get Involved
#1
Our current non-conformity procedure is that any claims raised by a customer is going through 8D process unless the claim is denied.
But our internal procedure is a bit more fluffy.
If non-conformity is found by final inspection -> 8D report
If non-conformity is found when doing in process measurements we evaluate the need for doing more than just registration.

Is there anyway this is conflicting with the requirements in AS9100. I don't believe it is, but a consultant who helped us out in the beginning of the transition from ISO9001 to AS9100 thought it were crucial to have the actual root cause and prevent the the re-occurence. And I believe our auditor agrees it him.

Our primary evaluation criteria is based on cost of the actual failure, the cost of preventing the failure, the risk of not finding the failure and the risk for our customers.
We do the registration because then we can track the costs of certain kind of mistakes like is it always like bad setup up of machine or high pressure pumps failing.

This way we are available to at some point to look at our high pressure pumps and see if doing something with those with minimize the amount and costs of NCs'.

We do a lot of non-aviation parts and we do a lot of mass production, so things like a broken drill or early wear on an insert does happen a lot. There is between 0-5 internal NCs a day, so doing 8D reports on everything is just a waste of resources in my oppinion.

Please share your thoughts.
 
Elsmar Forum Sponsor

Cari Spears

Super Moderator
Staff member
Super Moderator
#2
We do not initiate root cause investigation for every occurrence of nonconforming product. Our process is very much as you've described - we log nonconformances and try to track common causes that we may decide to initiate a CAR for - and sometimes something happens only once, but we initiate a CAR because it cost a lot or impacted our ability to deliver on time. We do initiate a CAR for all customer complaints or quality escapes.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#3
Doing an 8D for every nonconformity is, IMO, like going to the doctor for every injury you ever have, no matter the severity. Sometimes it's just a paper cut or a stubbed toe or slight muscle strain that doesn't need a doctor.

However, if your procedure says you shall go to the doctor for every injury you ever have, no matter the severity, you had better either follow it or revise it. I'd suggest the latter.
 

Kronos147

Trusted Information Resource
#4
...crucial to have the actual root cause and prevent the the re-occurence.
It's all about your system, and what you need to achieve your goals.

The standard says:

react to the nonconformity and, as applicable:
1. take action to control and correct it;
2. deal with the consequences;
evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:
1. reviewing and analyzing the nonconformity;
2. determining the causes...
3. determining if similar nonconformities exist, or could potentially occur;


No where does it say do an 8D.

If you have a process where you already 'know' the production problem causes (pump squeaks louder and makes a high frequency sound = gasket installed backwards), then you know the cause and you don't have to determine it (again).

If there exists the need to take action to correct it, do that, else control it and deal with the consequences (rework, scrap).

I will add, if you don't log these events, you may never know how prevalent it is. Some organizations may institute a three strikes, it's a corrective action type of policy. Do what makes the process effective. You are right to push back if 8D's become the tail that wags the dog. It makes them less effective when you really need them.
 

Big Jim

Super Moderator
#5
As pointed out above, the standard requires that you "evaluate the need". It doesn't require root cause analysis for all cases. You get to determine when you need to go beyond correction and into corrective action.

When you always dig deep you will always be running behind and trying to catch up, and when in catch up mode you are likely to miss the critical things.
 

thumphrey03

Starting to get Involved
#6
If there internal NCRs and not severe, keep them categorized as an NCR and stay away from recording them as a CAR. I'm sure there are several threads on the distinction. This will cause confusion on audits and customer calls reviewing your internal systems.
 
Thread starter Similar threads Forum Replies Date
A API Spec Q1 9th Edition - 12 month Internal Audit Schedule Audit Nonconformance Oil and Gas Industry Standards and Regulations 10
K Internal Auditing a previous Nonconformance? Internal Auditing 19
R Internal Audit Scope Requirements - Audit Nonconformance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Q Raising a Major Nonconformance during an Internal Audit Internal Auditing 23
E "Internal" CAPA (Audit Nonconformance) Issuance to your own Department Nonconformance and Corrective Action 4
J Auditing the Internal Auditing Process - Audit Nonconformance General Auditing Discussions 3
R Internal Audit Report Nonconformance Follow Ups Internal Auditing 5
S Do you tie a Nonconformance (NC) into the last Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
E Internal Audit Nonconformance Classification Internal Auditing 18
M Program of Internal Audits aren?t performed fully - Is it nonconformance? General Auditing Discussions 20
S External Auditor Findings when an Internal Audit found a Nonconformance Yesterday Document Control Systems, Procedures, Forms and Templates 11
T Incorrect Data in Inventory List - Internal Audit Nonconformance Nonconformance and Corrective Action 33
P Lack of 3rd Shift Internal Audit - Major or Minor NC (Nonconformance)? Internal Auditing 17
P Internal Audit NC (Nonconformance) is not closed - Is it a nonconformity? IATF 16949 - Automotive Quality Systems Standard 11
C SA 8000 Internal Audit - Anyone knows what a nonconformance in 9.7/9.7a be like? Other ISO and International Standards and European Regulations 14
C Alternate Terms for NonConformance, Internal Audits, Corrective and Preventative ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
S TS 16949 Clause 8.5.2 Audit Nonconformance for not issuing internal CARs IATF 16949 - Automotive Quality Systems Standard 14
Antonio Vieira The importance of some processes... Internal Audit, Management Review, Nonconformance Management Review Meetings and related Processes 3
C Internal Audit Training Help - Audit Nonconformance Training - Internal, External, Online and Distance Learning 11
J Nonconformance reports written only through internal audit findings? Nonconformance and Corrective Action 8
C Internal Audit - Is This A Nonconformance? Internal Auditing 31
A Definition Major vs. Minor Nonconformance (Finding) - Internal Audit - Definition & Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 38
R Monitor production quality - Internal KPIs Manufacturing and Related Processes 5
R IATF 16949 - Outsourcing of internal audits Internal Auditing 10
M Major vs. Minor for Internal Audits? Internal Auditing 10
M Tips on preparing for IATF 16949 Internal Lead Auditor exam Manufacturing and Related Processes 1
C Internal Audits in a tiny Dx Company Internal Auditing 33
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 4
F Internal Audit before Pre-Assessment ISO 17025 related Discussions 2
Q Internal audit plan template Internal Auditing 6
E PEMS Hazards - IEC 60601 Clause 14.6 - Internal data use - Pressure sensor IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L Internal audit during COVID-19 restrictions ISO 13485:2016 - Medical Device Quality Management Systems 5
A QMS Overhaul - Reorganizing and Renaming Documents - Internal References Document Control Systems, Procedures, Forms and Templates 18
N Sampling Plan for Internal Audits - ISO 2859 or 3951 - Or Neither? Internal Auditing 6
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
M Help me improve the definition for internal PPM Manufacturing and Related Processes 3
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 17
S Risk based internal auditing Internal Auditing 6
O Informational Scaling back internal audits due to corona virus while avoiding a NC Internal Auditing 7
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
G Addressing Non-Conformances from an Internal Audit that are not product related ISO 13485:2016 - Medical Device Quality Management Systems 11
S Software for Supplier Charge back and internal PPM General Information Resources 2
G Internal Audits and Employee engagement Internal Auditing 16
I What direction do you provide your internal auditors on OFIs? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
S Internal calibrations - Part of an ISO 17025 accredited testing laboratory (Automotive) ISO 17025 related Discussions 3
F AS9100D Internal auditing requirements Internal Auditing 3
B Internal and external auditor competency to CSR's IATF 16949 - Automotive Quality Systems Standard 20

Similar threads

Top Bottom