Question on Supplier Quality (SCAR)

duff999

Involved In Discussions
#1
I have a question related to managing the supplier quality (SCAR) process.

In a situation where the supplier implemented a corrective action that was deemed ineffective after verification what would be the next best steps:

1. Update the SCAR with the results and close out the CAPA that was issued to raise the SCAR, and then open a new CAPA and a new SCAR and start the process over?
2. Or is there a better process to document the next steps?

Any advice would be appreciated
 
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William55401

Quite Involved in Discussions
#2
Hello Duff999. This is a style question. You decide. As long as the overall outcome gets you to a verified CA, that is success. With that said, my gut reaction is to declare the EC (effectiveness check) ineffective and return the CAPA for reinvestigation. Go back to go, do not collect $200 (if I have to explain this, it's not funny..does anyone play board games anymore?.).

Your QMS procedures may explicitly state to close it as ineffective and open a new event. In the absence of QMS instruction, I would return the issue to investigation. Next time you update your SOP, add this workflow so you don't have to be creative next time an EC fails.

Have fun. Hope this helps. Enjoy the ride!
 

John C. Abnet

Teacher, sensei, kennari
Staff member
#3
Good day @duff999 ;
In all of the organizations I have worked for we developed a supplier handbook, which , ...
1- first and foremost, provided the information and tools (forms, links, etc... ) that the suppliers needed to interact with our organization and be
successful.
2- Listed all the terms/abbreviations needed to interact with our organization.
3- Laid out the rules of engagement
(I also help my clients construct similar handbooks).

As part f "3" above, we always described the QMR (Quality Management Review) process. Wherein, the conditions that may initiate a QMR are stated, including failure to reply, overdue CM, repeat failures, safety critical failures, line stoppage occurrences, etc..etc... Regardless of what it is called ("QMR< etc...), there needs to be a stipulated recourse. The QMR, as described here, required a member of the supplier management to come to our site and present in regard to how the occurrence was allowed to happen and the corrective action to prevent recurrence.

Keep in mind, however, a QMR should be a last resort for a problematic supplier. Hopefully you are able to mentor them by "red lining' their corrective action and retuning it to them. A strong relationship is the best approach when developing a strong supply chain. Teach them. Mentor them. Go to their site and review their processes and educate them. If all that fails, then having a QMR defined in the supplier handbook (which is /should be part of the "contract" with the supplier), should be initiated.

Hope this helps.

Be well.
 

John C. Abnet

Teacher, sensei, kennari
Staff member
#4
...by the way, It is helpful to have specific rules for what is a "CAR", what allows closure of a "CAR", etc..etc...

I would recommend that the original not be closed until an acceptable countermeasure has been received. IF the original was already closed, then a recurrence would (my recommendation) constitute creating a new event.

Hope this helps.
Be well.
 

Evelyn7E

Starting to get Involved
#5
I have a question related to managing the supplier quality (SCAR) process.

In a situation where the supplier implemented a corrective action that was deemed ineffective after verification what would be the next best steps:

1. Update the SCAR with the results and close out the CAPA that was issued to raise the SCAR, and then open a new CAPA and a new SCAR and start the process over?
2. Or is there a better process to document the next steps?

Any advice would be appreciated
Just curious what is your definition of not effective? Have you categorize the problem as special cause or common cause problem.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#6
Its up to you. I always imagine having to explain to a large customer why we did something and if I feel comfortable with that, its usually ok. Just obey your SOPs if applicable here.
 

Jim Wynne

Staff member
Admin
#7
Just curious what is your definition of not effective? Have you categorize the problem as special cause or common cause problem.
I don't know how many definitions of "not effective" are possible in this context. We should assume, for the purposes of this thread and the OP's question, that a nonconformity occurred, the supplier was asked to remove or neutralize the cause, and the supplier's efforts failed. I think also that application of special/common cause categorization is irrelevant; those terms are generally applied to control chart phenomena, in which case a common-cause issue may or may not result in a nonconformity.
 
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