Root Cause of 'Supplier Evaluation Not defined'

[MEDQA]

Hello -

I'm probably making this harder than it needs to be, but I need some input on an appropriate root cause.

We have an Internal Audit finding that our supplier evaluation / selection requirements are not defined.

Some background -

1. Quality Manual has the ISO statement "selected based on their ability to supply products or services as per our requ."
2. Re-evaluation is defined.
3. All of our suppliers are either mandated by our customer, the sole supplier of a product, or carried over from a parent or sister company. (I can think of 1, since the audit, that we actually evaluated & selected)
4. Selection / Evaluation records were not available for the audit b/c all suppliers to date were as stated in #3 and were in the picture before we committed to be compliant.
5. This was our 2nd internal audit after releasing our procedures.

RC -

CA - Define / document selection. We will continue to assess our QMS and procedure compliance via audits.

 

[somashekar]

Re: Root Cause Supplier Evaluation Not defined - Help

Criteria for selection, evaluation and re-evaluation shall be established.
Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.
mandated by our customer, A big criteria...
A record of customer stating the same will do + records of continued good supply performance makes for re-evaluation.
the sole supplier of a product Itself is a criteria. I hope you are sure about it and can be justified as sole within your economical operation + records of continued good supply performance makes for re-evaluation.
carried over from a parent or sister company. That they have been making and supplying you parts per your requirements itself from long periods is a criteria + being your parent / sister company adds on to support supplier interaction. As long as they are making and supplying you parts, and you have records of continued good supply performance, it makes for evaluation / re-evaluation.

(I can think of 1, since the audit, that we actually evaluated & selected)

I guess you wanted to say (I can't think of 1, since the audit, that we actually evaluated & selected) but actually you are just fine.
You do not have to do anything differently but just understand your business and the ISO9001 requirements and map them to your business.
Going forward, when you wish to evaluate and select a new supplier, you will know what to do, when you reflect upon what has been working well for you, OR at that point of time a new criteria may perhaps evolve.
Keep going ~~~

 

[MEDQA]

Re: Root Cause Supplier Evaluation Not defined - Help

Good Morning,

Thank you for the confirming we are on the right track.

We did accept 1 new supplier, (they were evaluated because they have a relationship with our sales partners, and we had a need for their services).

We forwarded our expectations (sample pieces and drawings), they provided samples for review until we came to agreement on what was acceptable. Now they are on the Approved Supplier List.

I am still struggling with an appropriate root cause when procedures don't identify what they claim to identify.

I know this isn't new to have a fresh pair of eyes say "ah, you think you have it, but I don't see it". If you truly thought the document had "it", and later find that it didn't... is it human error, a misunderstanding, poorly reviewed??

thanks

 

[John Broomfield]

Re: Root Cause Supplier Evaluation Not defined - Help

MEDQA,

Furthermore, do you update supplier selection criteria when you have evidence of poor performance and when you require improved supplier performance?

John

 

[Bev D]

Re: Root Cause of 'Supplier Evaluation Not defined' - Help

why do you need root cause? sometimes correction is enough. Why not just add the evaluation and selection process for suppliers that you must select.

 

[MEDQA]

Re: Root Cause of 'Supplier Evaluation Not defined' - Help

Yes we do and will.

I really need suggestions on how to phrase the root cause appropriately.

 

[Bev D]

Re: Root Cause of 'Supplier Evaluation Not defined' - Help

how about: "because we hadn't evaluated and selected suppliers on our own prior to developign our supplier documentation it simply didn't occur to us to document a process we'd never used."


Then remember it's an internal audit - move on. No offense, but what value add is there to continuing to expend energy on this issue? The intent of internal audits is to identify gaps that have the potential for creating defects or waste in the process. The audit has done that in this case.

 

[somashekar]

Re: Root Cause of 'Supplier Evaluation Not defined' - Help

Yes we do and will.

I really need suggestions on how to phrase the root cause appropriately.

Your RC.
1. You had some evaluation and selection criteria but you did not know you had them.
2. You had records of evaluation / selection but you did not know you had them.
Now, without a RC you could not have written your CA that addresses your RC

 

[LUV-d-4UM]

Re: Root Cause of 'Supplier Evaluation Not defined' - Help

Evaluation and Selection of Suppliers must be defined by Contract and Procurement. They have to have criteria for selecting the suppliers before awarding them the contract. All you need to do here is to define how the contract is awarded. Usually the criteria is cost -number 1 and quality number 2. Whatever it is, you must define it in the manual and if there is an example of a Contract that has been awarded to a supplier, that is the record.

 

[MEDQA]

Re: Root Cause of 'Supplier Evaluation Not defined' - Help

why do you need root cause? sometimes correction is enough. Why not just add the evaluation and selection process for suppliers that you must select.

If this is an audit finding, I thought it required a root cause.