8.2.4 "Evidence of conformity with the acceptance criteria shall be maintained."

[Douglas E. Purdy]

May be - May be not!

That makes sense, thanks.

Maybe I'm making a mountain of paperwork where there only needs to be a molehill. We do have records of the person doing final inspection and product release, but we don't keep records of in-process inspections, and I'd rather not start now.

Tim

Tim,

If your planned arrangements are to only verify that product requirements have been met at Final Inspection, then you do not have to generate in-process inspection records. But if your planned arrangements are to verify product requirements at other appropriate stages, then you would need that 'Evidence of Conformity' and 'Records shall indicate the person(s) authorizing release of product.'

Fuzzy,

Thanks for catching my error - the definitions are in 9000 and not 9001. In your situation, did you plan for In-process Inspection and not have the 'Evidence of Conformity' and 'Records'?

Additional Question

If in the planned arrangements, you are requiring some certification(s) from your supplier (e.g. Material Certification, Certificate of Conformance, etc.), are you required to have those certifications in hand before you release the product or deliver your service per 8.2.4.?

Doug

 

[fuzzy]

Scary Mind-Reading

Fuzzy,

Thanks for catching my error - the definitions are in 9000 and not 9001. In your situation, did you plan for In-process Inspection and not have the 'Evidence of Conformity' and 'Records'?

Additional Question

If in the planned arrangements, you are requiring some certification(s) from your supplier (e.g. Material Certification, Certificate of Conformance, etc.), are you required to have those certifications in hand before you release the product or deliver your service per 8.2.4.?

Doug[/QUOTE]

Doug,

Do you work here with me? How could you be in IL? Your two questions bore to the heart of some issues our QMS has. My 20+ years in automotive supply color my thinking within my current industrial commodity / technical government project enterprise. The documentation of in-process inspections was/ is not a fully established system in my view (I like to call them "practices"). So in the absence of well defined criteria, training, and records, we have adapted more general assessments of conformance. These seem to have served the purpose of compliance, but may not have added value ultimately. Trying to apply a Contol Plan methodology to our product has recently driven this home.
If your additional question was posed to me, I am scared as I know someone :ca: who has recently been assigned to get a system in place for QA control of Receiving Inspection and the very issue you posed. Does the Forum allow a viewport into my PC????:mg:

 

[vanputten]

Inprocess inspections may be a tool to understand the process, or at least the output of a process. There may be no reason to use them to monitor inspectors, technicians, or operators. You could use them to monitor maintenance, engineering, design, etc. It may be a tool to improve a process.

I would say that you are required to have supplier certifications in hand before you release the product. Otherwise, what is the point? To have them after you release product? Closing the barn door after the horse is gone? Why ask for them at all?

Seems like there is some unnecessary risk in releasing product without the defined verification in hand, which in this case is the supplier cert.

Regards, Dirk

 

[Douglas E. Purdy]

Inprocess inspections may be a tool to understand the process, or at least the output of a process. There may be no reason to use them to monitor inspectors, technicians, or operators. You could use them to monitor maintenance, engineering, design, etc. It may be a tool to improve a process.

I would say that you are required to have supplier certifications in hand before you release the product. Otherwise, what is the point? To have them after you release product? Closing the barn door after the horse is gone? Why ask for them at all?

Seems like there is some unnecessary risk in releasing product without the defined verification in hand, which in this case is the supplier cert.

Regards, Dirk

Dirk,

I am in agreement with you, but I am in a QC culture that is fragmented. Why does an inspector who is performing Final Inspection having to go verify that the material certifications from the steel and carbide are retained? If we really did hold up the material until the certs were received, then we must have the certs available for when we release the finished product.

Doug

 

[Douglas E. Purdy]

Re: 8.2.4 & Product Release

Based on the definition of 'release' (3.6.13 - ISO 9001) "permission to proceed to the next stage of a process" - what or who determines the next stage? Case in point, a manufacturing route identifies the sequence of operations and the practice is that as long as the operations are in a given work-center the product can move from one operation to another in that work-center without having the previous operation complete or signed-off on the manufacturing route. Is the 8.2.4 requirement being met if this situation is deemed acceptable during the monitoring and measurement, or could a registration auditor say we are not in compliance with the standard?

Another question on this subject: Is the second paragraph with the requirement "Records shall indicate the person(s) authorizing release of product" relating to the same product release in the third paragraph "Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorilly completed"? Or is the standard informally identifying In-Process Inspection in the second paragraph and Final Inspection in the third paragraph?

I look forward to any feedback on this matter.

Thanks,
Doug

PREFACE
A little over 2 years later and in a QMS registered to ISO / TS-16949 (A Control Plan Environment) and I still do not have a definite answer to my questions above. Currently I have an issue with Management on the subject and they believe that it is only my interpretation - since our registrar has never issued a finding.

The finding was where a partial lot of product waiting Verification of Purchased Product per Control Plan is released to Finished Goods and to Shipping where a Dock Audit is performed. Both the Receiving of Plated Product and the Dock Audit are on the Control Plan. The Dock Audit is basically a visual (similar to the Receiving Inspection which also reviews the Supplier Certification to the PO requirements) along with checking the packaging and labeling requirements, but at a lesser sampling size.

The current employer has a procedure for "Urgent Release" but has only practiced it in reqards to receiving raw material (coils of metal strips). The following requirement comes from a procedure for Inspection & Test Status:

2.5 In all cases, product may not be moved to the next operation without the proper inspection approval unless Urgent Release processes have been properly followed. Employees at each operation are responsible for ensuring that the means of identifying approval is clearly marked on the product before it is used.

This procedural requirement is contradictory. The first statement would be in-line with the control plan, while the second sentence just ensures the status without necessarily having the inspections completed (i.e., Last Piece).

I wrote the finding against 8.2.4 and their Inspection & Test Status procedure. Management does not agree with the finding. What should I do?

Thanks,
Doug

 

[vandenbar]

Doug,

If I interpreted your post correctly it sounds like you have a different understanding of the wording in a procedure then the management group. Why not propose changing the wording in the procedure that would clarify it for you and remove any misinterpretation? Sell it under the premiss that if you find it confusing or open for question then an external auditor might or even worse an operator. You could remove the finding to smooth out the situation or capture it as a PAR. If it gets clarified then either way you've accomplished the final objective and improved the system.

My two cents,

 

[Douglas E. Purdy]

Doug,

If I interpreted your post correctly it sounds like you have a different understanding of the wording in a procedure then the management group. Why not propose changing the wording in the procedure that would clarify it for you and remove any misinterpretation? Sell it under the premiss that if you find it confusing or open for question then an external auditor might or even worse an operator. You could remove the finding to smooth out the situation or capture it as a PAR. If it gets clarified then either way you've accomplished the final objective and improved the system.

My two cents,

Thanks for your feedback, I definitely was heading in that direction - to clarify the Inspection & Test Status requirement. But I have to get management to understand the requirement first - which is centered on the questions posted in 2005:

Another question on this subject: Is the second paragraph with the requirement "Records shall indicate the person(s) authorizing release of product" relating to the same product release in the third paragraph "Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorilly completed"? Or is the standard informally identifying In-Process Inspection in the second paragraph and Final Inspection in the third paragraph?

What is the proper understanding of the second and third paragraph of 8.2.4, and what am I to do with Management who believes that this is just my interpretation, when the registrar has never given them a finding in this matter?

Just to clarify my understanding, I believe that the 8.2.4 requirement is saying what the first sentence in the Inspection & Test Status procedure states:

In all cases, product may not be moved to the next operation without the proper inspection approval unless Urgent Release processes have been properly followed.

I was not here when this procedure was written, so I am not the only one who believes that this is what 8.2.4 is requiring.

Thanks,
Doug

 

[vandenbar]

Doug,

You've got some good questions. IMO or my interpretation of the standard (referring to 8.2.4) I believe that the second paragraph is referring to all points in your process where the acceptance criteria is checked. This could be inprocess inspection, receiving inspection, final inspection, reviewing performance test data or CofA's, etc. Anywhere in your process where someone checks the product/service to see if it is meeting the requirements set out by your company or your customer.

The third paragraph states product release and service delivery - this seems to suggest the end of the process and delivery to the customer but you can release product from receiving to storage or production or from one operation to the next so it is also applicable to your entire process.

You need to ask yourself what the intent of this requirment is. I would say it is to:
1. Check to see if your product meets the requirements where and when you already determined it to be important in your process (appropriate stages).

2. When you check it, document that you did and know who did it. Also make sure that who did is allowed to do it.

3. Don't move it to the next step until it passes all the requirements you've set for it, unless someone with the authority says you can go ahead - typically the cusotmer or someone with the guts to put their name on a waiver. At this point the "Urgent release" process comes into play.

That's what I think anyway.

 

[Douglas E. Purdy]

vandenbar,

Nicely Stated! At least I do not feel like a complete incompetent. Now how do I convince Management that this is the requirement, when they have been operating this way for years?

You previously indicated:

Sell it under the premiss that if you find it confusing or open for question then an external auditor might or even worse an operator. You could remove the finding to smooth out the situation or capture it as a PAR. If it gets clarified then either way you've accomplished the final objective and improved the system.

How can I remove the finding and capture it as a PAR, when it is a known nonconformance?

Thanks,
Doug

 

[CliffK]

Re: 8.2.4 & Product Release

PREFACE

I wrote the finding against 8.2.4 and their Inspection & Test Status procedure. Management does not agree with the finding. What should I do?

Thanks,
Doug

Forget the finding unless you can show a demonstrable impact on quality. From everything that's been said so far, it seems that the management team supports the current document, they are managing successfully according to their interpretation of the document and the product quality is not adversely affected.

What happens if you push your CAR and "win?" Will there be a measurable improvement in product quality or a reduction in cost? If not, all the time spent arguing the point will have been wasted effort. In addition, you will probably succeed in alienating the management team against yourself and creating one of those "auditor made us do it" situations.