Should a supplier self assessment form be a controlled document?

[thekellyg]

Searched and don't find an answer so here is the question:

Should a supplier self assessment form be a controlled document? We have a third party company coming to do a gap analysis next week after which they are producing the manual (and they are going to find more of a gulf than a gap across the board. I feel like the little Dutch boy and need thousands of fingers.) so if the answer is "depends on how you write your Manual", I'll work it out with them. As always, thanks for your guidance!!

 

[Reg Morrison]

Re: Supplier assessment form

We have a third party company coming to do a gap analysis next week after which they are producing the manual

Sorry for not answering your question, but be careful with "third-party" developed manuals. Many times, they will "develop" a manual that is a canned template and your manual ends up being exactly like hundreds of other victims clients.

There are some unaccredited outfits that sell a bundled implementation and certification and, the "implementation" phase is nothing more than a farce in interviewing the staff, disregarding all of the information collected and printing a manual with your company's name in it. Be aware.

 

[PaulJSmith]

Re: Supplier assessment form

Clause 7.4.1 requires that you keep records of the evaluation of your suppliers. What those records are is determined by you. So, unfortunately, the answers is that it indeed is determined by how you write your manual and/or procedure which will govern that process.

 

[kgott]

Searched and don't find an answer so here is the question:

Should a supplier self assessment form be a controlled document? We have a third party company coming to do a gap analysis next week after which they are producing the manual (and they are going to find more of a gulf than a gap across the board. I feel like the little Dutch boy and need thousands of fingers.) so if the answer is "depends on how you write your Manual", I'll work it out with them. As always, thanks for your guidance!!

I worked for a company (shipyard) whose procedures where written by a consultant. Their confined space procedure went to 13 pages. They covered every conceivable base they could think of. (think consultant CYA) The document did not reflect the shipyards own confined space issues.

Who is ever going to read that apart from me the HSEQ person? This is what happens when they bring in consultancy services based on package pricing and not on re-searching how work is done and reflecting that in documentation.

 

[AndyN]

Searched and don't find an answer so here is the question:

Should a supplier self assessment form be a controlled document? We have a third party company coming to do a gap analysis next week after which they are producing the manual (and they are going to find more of a gulf than a gap across the board. I feel like the little Dutch boy and need thousands of fingers.) so if the answer is "depends on how you write your Manual", I'll work it out with them. As always, thanks for your guidance!!

Firstly, don't sweat the gap analysis. It's not the certification audit. Secondly, if you are going to use your supplier assessment form to meet the requirement of ISO 9001 to perform supplier evaluation/re-evaluation, then yes, it has to be controlled, because it's part of the management system.

There's nothing wrong, per se, about having someone draft a quality manual - it's HOW they do it you have to be in control of.

 

[harry]

I think it has to do with the rigid mindset of many people in the quality area. When you talk about control, what level of control do you have in mind?

I practice, the relevant department such as purchasing which is handling the sending and receiving of the forms whether by fax, email or snail mail would have records which is a good enough control for traceability and retrieving purpose.

Do you need to control the format? Many people do it and make it part of the QMS documents but think about it - if the contents in such a form are fixed, would it be useful year after year and in the face of changing market conditions?

 

[MikeLQSR]

There are a few areas that can potentially tie into this answer in regards to ISO 9001 / 13485 as well as 21 CFR 211, 820 (training and supplier qualification specifically). If your company has a Supplier Quality Engineer (or the like) they will be asked (by auditors) about the SQE's training and specifically the qualifications of reviewing the self assessment as well as what actions are taken in regards to poor self assessments - this will then tie into purchasing controls (eg approved supplier list's, disqualification of suppliers, etc).

While this does technically tie into the Quality Manual, it does have a much broader scope which on the surface that usually goes un-noticed - it can be tied into the following clauses is ISO 9001 :

1) 5.6 - management review : Does / How does management review the self assessments? If the supplier is qualified / disqualified is management notified?

2) 6.2.2 - Training (also ties in with ISO 19011 if the SQE is an auditor as well)

3)7.1 Planning of product realization - if the self assessment is used initially to qualify a supplier then it becomes a record and should be retained and controlled

4) 7.4 - Purchasing - fits into many of 7.4's subclauses...

5) 7.5.3 - traceability - along with your self assessment you should strive to obtain full product / material traceability and visibility. Within my organization we have a "cradle to grave" policy. We know where the material starts life all the way to whom the customer is.

These are just some of the major tie in's an auditor can say that a self assessment can potentially fit into. Bottom line - all documents relating to supplier quality should be controlled - period.

Hope this helps!
Mike

 

[John Broomfield]

thekellyg,

Is the supplier at liberty to delete the awkward questions?

Of course not!

Yes, you control the form to prevent unauthorized changes.

You can define the degree of control for each system document according to the risk.

But most of us opt for standardized controls to:

• Indicate the document's status (draft or approved)
• Uniquely identify the document
• Be sure of making available only the correct version

John

 

[PaulJSmith]

One thing not particularly clear here, thekellyg, is what self assessment form are you talking about? Is it the form itself that you send to suppliers? Is it the completed form (now a record) returned from your suppliers? Or is it the forms you complete for your customers?

 

[db]

...Should a supplier self assessment form be a controlled document?

There is no direct requirement to use a form, and no direct requirement that it be controlled, if you do. However, look at 4.2.1d. Part of your required documents include those documents necessary to ensure effective the planning, control or operation of your processes. So, I will bounce the question back to you. Is this form important in your process of supplier management? Only you can answer that, but I would tend to think that this document should be a controlled document.