Maintain records of the "Nature of Nonconformities" - ISO 9001 Clause 8.3

Douglas E. Purdy

Quite Involved in Discussions
Preface: I searched this forum as well as the forum on Control of Nonconformances and did not find an interpretation on this terminology and I also checked the ISO Interpretations and the ISO 9000 Vocabulary.

Question: When we are to maintain records of the 'nature of nonconformities' and any subsequent actions taken, what does that mean? Is it sufficient to only quantify the number of scrap, rework, repair, use-as-is, on the manufacturing route, or do we need to describe the actual nonconformance?

Your feedback would be greatly appreciated.

Thanks,
Doug
 
Elsmar Forum Sponsor
Douglas E. Purdy said:
Preface: I searched this forum as well as the forum on Control of Nonconformances and did not find an interpretation on this terminology and I also checked the ISO Interpretations and the ISO 9000 Vocabulary.

Question: When we are to maintain records of the 'nature of nonconformities' and any subsequent actions taken, what does that mean? Is it sufficient to only quantify the number of scrap, rework, repair, use-as-is, on the manufacturing route, or do we need to describe the actual nonconformance?

Your feedback would be greatly appreciated.

Thanks,
Doug
I believe it means your records include the description of the nonconformities, the dispositions, the corrections and any corrective actions taken.
 
Douglas E. Purdy said:
Preface: I searched this forum as well as the forum on Control of Nonconformances and did not find an interpretation on this terminology and I also checked the ISO Interpretations and the ISO 9000 Vocabulary.

Question: When we are to maintain records of the 'nature of nonconformities' and any subsequent actions taken, what does that mean? Is it sufficient to only quantify the number of scrap, rework, repair, use-as-is, on the manufacturing route, or do we need to describe the actual nonconformance?

Your feedback would be greatly appreciated.

Thanks,
Doug
I have always been liberal in my interpretation of this clause from ISO 8.3.

I consider the "nature" of the nonconformity in broad terms (documentation, physical characteristics.) I further divide physical characteristics into those created in the manufacturing process and those which may be created after manufacturing, but before final delivery to customer (count, damage from handling or shipping, mixing with other parts, etc.)

The records I keep about nonconformities are comingled with the part or shipment record (I made custom parts - record-keeping may be different for those making off-the-shelf products sold to multiple customers.) For each part, I record the exact nonconformity (sharp burrs) plus the action taken (tumble to remove burrs.)

"Actions" include main and subtopics (the "nature" of actions)
Bookkeeping:
  • authorize return
  • authorize scrap or destruction at customer to save shipping costs
  • credit, repair, or replacement after shipment
  • repair or replace before shipment
  • obtain "concession" AFTER shipment
  • obtain "deviation" BEFORE shipment
Process
  • determine cause of nonconformity
  • correct faulty step (manufacture, finish, documents, handling, etc.)
  • evaluate correction for adequacy
  • consider change or improvement (prevention)
 
Al Rosen said:
I believe it means your records include the description of the nonconformities, the dispositions, the corrections and any corrective actions taken.

Al,

When you have incidental scrap from say, setting-up an operation, do you describe the nonconformity, the actual characteristic(s)?

Thanks,
Doug
 
Wes Bucey said:
I have always been liberal in my interpretation of this clause from ISO 8.3.

I consider the "nature" of the nonconformity in broad terms (documentation, physical characteristics.) I further divide physical characteristics into those created in the manufacturing process and those which may be created after manufacturing, but before final delivery to customer (count, damage from handling or shipping, mixing with other parts, etc.)

The records I keep about nonconformities are comingled with the part or shipment record (I made custom parts - record-keeping may be different for those making off-the-shelf products sold to multiple customers.) For each part, I record the exact nonconformity (sharp burrs) plus the action taken (tumble to remove burrs.)

"Actions" include main and subtopics (the "nature" of actions)
Bookkeeping:
  • authorize return
  • authorize scrap or destruction at customer to save shipping costs
  • credit, repair, or replacement after shipment
  • repair or replace before shipment
  • obtain "concession" AFTER shipment
  • obtain "deviation" BEFORE shipment
Process
  • determine cause of nonconformity
  • correct faulty step (manufacture, finish, documents, handling, etc.)
  • evaluate correction for adequacy
  • consider change or improvement (prevention)

Wes,

So, your meaning is liberal? Apparently not as liberal as just tallying the quantity of tools that are scrapped, reworked, use-as-is, etc.

Thanks,
Doug

P.S. Are your responses off-the-cuff (just sit down and write), or do you cut & paste from writings that you have? Just Wondering!
 
Douglas E. Purdy said:
Al,

When you have incidental scrap from say, setting-up an operation, do you describe the nonconformity, the actual characteristic(s)?

Thanks,
Doug
If the scrap is the result of normal set-up of the process, I would not consider it as a reportable non-conformance. If on the other hand the parts are presented for acceptance and it is determined that the set-up is not correct, then it is reported as a non-conformance with a complete description. Scrap is reported whether it is a result of set-up or a NC. If you are monitoring scrap as part of Cost of Poor Quality you will be able to detect any increase in scrap and determine through root cause analysis whether it is caused by nonconformance or set-up problems.
 
Douglas E. Purdy said:
Wes,

So, your meaning is liberal? Apparently not as liberal as just tallying the quantity of tools that are scrapped, reworked, use-as-is, etc.

Thanks,
Doug

P.S. Are your responses off-the-cuff (just sit down and write), or do you cut & paste from writings that you have? Just Wondering!
I was only talking about dealing with products made for others and nonconformities to them. My accounting for setup is a flat engineering charge to the project, regardless of how much material may be spoiled prior to First Article. Everything after First Article Approval is subject to nonconformance report and (maybe) Corrective Action Report if Material Review Board dictates. Often, the nonconformity reason is obvious (power outage, dropped part, bar short, etc.) which are normal variations to be expected over long production runs and are definitely not "systemic") Production Tooling wear and breakage is tracked and often investigated, but does not open an NCR unless resulting product is nonconforming.

These are all internal activities, before product has opportunity to reach customer. Slightly different protocols, especially handholding of customer, kick in if a nonconformity is discovered at customer or by us after a shipment is en route.

I meant "liberal" as opposed to "literal" in regard to "nature of" by disregarding any metaphysical attribute of "nature" and just dealing with the specifics which can be measured and tallied. Those specifics are what are important to us in being as efficient as possible and, additionally, to our customer so he may be assured we are delivering conforming product and doing everything we can to minimize his grief if some should slip through. I did not bother to go into concepts of segregation and quarantine of suspect product until final determination by MRB whether product was nonconforming and what its final disposition should be. In most cases, MRB also deals direct with customer in getting concessions (post shipment) or deviations (pre-shipment.) MRB consults with accounting and management as well as customer to determine whether product confirmed as nonconforming at customer's location should be returned for credit or replacement or rework or scrapped directly from customer's site to save shipping costs. MRB almost never authorizes ANY movement of the product from segregation in-house or at customer until confirmation or denial of nonconformance is made. The record of the action of the MRB is actually the primary record which applies in my mind to this clause of ISO. Our MRB report is made part of the product history and kept as part of that record. The MRB reports are reviewed during management review to consider whether MRB action was sufficient or if something more should be done, either on the product or on the MRB process itself.

It may be important to consider that all of ISO is written for a "generic" organization, including some where getting pre-approval for shipment or concession from a customer is impossible and hence "relevant authority" (8.3.b) which might be a regulatory body (FAA, FDA, etc.) or just the product manager, who makes a judgment call.

8.3 says:
8.3 Control of nonconforming product
The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for
dealing with nonconforming product shall be defined in a documented procedure.

The organization shall deal with nonconforming product by one or more of the following ways:

a) by taking action to eliminate the detected nonconformity;
b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;
c) by taking action to preclude its original intended use or application.
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained.

When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.

When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.


99% of my posts are "impromptu" or off-the-cuff. Almost always, if I dredge up some document, I make reference to it, regardless if I was the author or someone else, usually also printing it in a different font or color than the rest of the post. If a post seems like a "prewritten document" - that's very flattering.
 
Back
Top Bottom