Documenting Quality Inspections - Material Released prior to Lot Acceptance

[rgunn1]

Hi all. I've been lurking the forum for a while, and my company has charged me with the task of overseeing the development and implementation of our new QA program. I have developed a form to be used for inspecting incoming material as it is received from our vendors. The form that I have developed can currently account for accepted, rejected, and pending materials. I am having trouble trying to logically and concisely account for accepting material originally classified as pending, when a portion of the order had already been accepted.

I don't know that this situation can occur given the policies we have in place, but I am trying to consider all possible scenarios as we are developing our policies and procedures.

We are currently trying to implement systems in accordance with ASME Boiler & Pressure Vessel Code, Section III, Subsection NCA 3800 as well as MIL-I-45208A (each at different locations).

Any insight or advice is greatly appreciated.

Thanks,
R

 

[Marc]

Re: Documenting Quality Inspections

I'm trying to remember what it's called, but essentially you can release material for production from a lot when lot acceptance isn't complete as long as you have forward traceability for what was released and used in production so that you can effect positive recall should the lot be rejected. Obviously, there is a risk and $ factor involved.

Note: I am not knowledgeable in ASME Boiler & Pressure Vessel Code so I have no idea if there is anything in it to preclude the above.

 

[Stijloor]

Re: Documenting Quality Inspections

I'm trying to remember what it's called, but essentially you can release material for production from a lot when lot acceptance isn't complete as long as you have forward traceability for what was released and used in production so that you can effect positive recall should the lot be rejected. Obviously, there is a risk and $ factor involved.

Note: I am not knowledgeable in ASME Boiler & Pressure Vessel Code so I have no idea if there is anything in it to preclude the above.

Marc,

It was called the "Positive recall procedure."

It was a requirement in a previous ISO 9001 (1994) standard.

4.10.2.3 Where the incoming product is released for urgent production purposes prior to verification, it shall be positively idenified and recorded (see 4.16) in order to permit immediate recall and replacement in he event of nonconformity to specified requirements.

Man, do I miss these days....

Stijloor.

 

[Marc]

Re: Documenting Quality Inspections

You can still do positive recall to the door without a problem. You *can* do it to customers, I suppose, but each occurrance would be so different it would amount to what I used to know years ago as a material review board. That is, there would have to be a judgement made on a case by case basis as to whether to stop at the door or let the product proceed to the customer. Someone would ultimately have to take responsibility for the release of the product at each stage.

That said, I'm sure this would be prohibited in some industries such as pharma. But again, it would depend upon the specific situation. Let's say it's pharma and the material released was simply the bottles the drug goes in as opposed to the drug. It comes back to why the material is on HOLD or has not been processed through receiving and the potential ramifications/risks.

 

[rgunn1]

It seems to me the best way to approach this situation will be to not allow partial lot acceptance in the first place.

 

[hogheavenfarm]

That is the simplest way, but rarely do simple solutions work out well in the real world. There seems to always be an *urgent*, *critical* , ****RUSH*** to get product out the door, (so someones KPI can look good), rather than have the luxury of holding it.

 

[Pogi_]

I think this is what you call a "RISK" release. And it does exist. I can discuss it more but I reserved the right not to...personal and profesional reasons.

"Pending materials" by its term is pending. By QA unwritten rule all pending materials are as good as "HOLD" and may go either accept or reject depending on your material review board disposition process or your dept OCAP or engineering dispo, whichever is appropriate. Bottom line you should NOT be moving any materials in this status unless someone puts his name and credibility on it (like the company owner... ).

Another way to go around this (..looks are product and process engineers...) is by building it through engineering build process. Gives more eyes and papers into it, but you'll be sure that the product that was built using pending materials is handled with TLC....just a thought . QA loves this - but operation / production will hate you for it - it will kill their CT.

 

[Norm Moreau]

The approach I have seen at nuclear power plants where such a product might be used is that the item(s) is considered nonconforming and not allowed to go into production until QC release. Most manufacturers have a QC check prior to release of a product to confirm that all nonconformances against the product have been closed. Obviously such an approach assumes that the NCR process is solid. NCA 3800 doesn't have the details for such a condition, in fact NQA-1 (which is more detailed doesn't specifically address this either).

 

[Rick Hart]

Generally, the best method is a risk release program. The RR form will detail the nature of the RR and a manditory hold point that will prevent the material from shipping until all product acceptance is complete.

 

[rgunn1]

Wow. Back from the dead. Our whole nuclear program pretty much got put on "hold" (ironically), but will be coming back to the forefront of our objectives very soon. Thanks for all of the replies. I appreciate the insight.

R