How Can I Respond to this SCAR (Supplier Corrective Action Request)?

Background -

A product was sent out containing an ingredient that was not specified in the specification. The R&D technician did not properly update the file, therefore, leaving the old formulation which was used to make a lot of material.

Sales asked the R&D Tech to make the change to the file orginally, and did not complete a Specification Review Document. This was all done through email instead. If a Spec Rev Doc would have been completed, the R&D Technicians work would have been reviewed and the error would have been noticed.

The Specification for this formulation was also in the file. The QC Technicians and QC Managers are suppose to review this document when the product is running and immediately prior to shipment. It was not reviewed closely enough. If so, they would have seen that the wrong ingredient was used and stopped the shipment.

Now I have a SCAR to complete. I am at a loss of what to document because the customer has listed the following:

Root Causes to be avoided
The following are commonly identified as root causes, but are only symptoms to the true root cause and should be avoided in the SCAR response:
? Human error
? Procedures not followed
? Equipment malfunction
? Improper performance
? Method not validated
? Multiple batches in process at the same time
? Equipment with expired calibration
? Out of trend point



Corrective Actions to be avoided
The following are commonly identified as Corrective Actions to attack the root cause, but are only simple spot fixes and should be avoided in the SCAR response:
? Train a non-trained operator
? Reject and destroy a failing product
? Rework nonconforming material
? Repair broken piece of equipment
? Properly connect alarm to machine
? “Use-as-is” nonconforming product



A lot of bad things happened in this situation - but how am I to respond? I will of course want to retrain everyone.

Thoughts?

Re: How Can I Respond to this SCAR?

Seems to me that a procedure wasn't followed. So while they don't want that listed as the root cause, you need to go further and figure out why it wasn't followed? My guess is either they didn't know or forgot because it isn't an everyday occurrence. Good luck.

Re: How Can I Respond to this SCAR?

Looks like they want you to dig deeper than a procedure not being followed. How can you error proof out that a different procedure won't have the same type of problem at some point in the future. This would be a good 5 why with a team to determine the real root cause and action to solve it.

Re: How Can I Respond to this SCAR?

From your description of the CAR, your system was ineffective in four separate instances.
-Sales did not submit the proper paperwork
-R&D did not insist on properly completed paperwork and did not route for review
-QC did not catch the error when the product was running
-QC did not catch the error prior to shipment.
Another area you didn't mention is operator responsibility.
IMHO, you have a systemic problem. People throughout your organization have become lax in following procedure. Your Corrective Action needs to address this systemic problem and simply retraining may not be the answer. Good Luck!

All good responses.

May I add that your customer's response points out some typical root cause responses are not really root cause, just causes along the way.

It also points out that some common corrective actions are inappropriate since they probably were part of the correction/containment. Most importantly, they don't speak to the cause.

A little explanation may help. ISO 9000 defines correction as the action taken to overcome a nonconformance. It needs to include containment. It is unfortunate that the word action is in the definition, as it tends to muddy things up, but follow along and it should get cleared up.

ISO 9000 defines corrective action as the action taken to overcome the CAUSE of the nonconformance. It should be clear then that the corrective action needs to speak to the root cause. It is NOT a continuation of the correction!

This will also give you a great opportunity to communicate to all employees the effectiveness of your QMS (ISO 9001 clause 5.5.3) and the importance of their activities and contribution to quality objectives (6.2.2d).

Re: How Can I Respond to this SCAR?

qualityfox said:

-R&D did not insist on properly completed paperwork and did not route for review

Click to expand...

Here is why the need for the paperwork was not pushed. The R&D Technician IMHO should not have been doing the update in the first place. She was only with our company with a total of four months, and I don't believe her manager properly trained her.

Secondly, the Spec Rev Doc was implemented only a short time before this, and the process of who reviews it was still being discussed. We were basically working with it and trying to hammer out the bugs that we came across.

I agree this is a systemic problem, and I also agree that the items the customer listed to be avoided are not all appropriate.

I think a HUGE communication break-down started this snow-ball. While top management was aware of the Spec Rev Doc, I dont believe it was properly filtered down to the other employees.

NikkiQSM said:

I will of course want to retrain everyone.

Click to expand...

Yes. But, before you even consider that, you need to address the multiple failures in the system. Otherwise, you'll just end up retraining people on a system that didn't work as intended.

I don't think this will be an easy or short response, as already noted by others. You might consider several teams, one for each area of failure. This may help alleviate some of the burden, and make it feel like less of a daunting task.

What is everyone thoughts on this? :::

Complaint: Product contained an unspecified ingredient.
Investigation Details:
? QMF 10 – Specification Review Document – Began being used April 2014.
? Product’s file indicates that the formula was updated in Nov 2014.
[FONT=&quot]o [/FONT]Formulation was only partially updated, not completely.
[FONT=&quot]o [/FONT]Employee had only been with the company for four months.
? Why was the formula not updated correctly?
? Process was not clearly communicated to all employees / poor training
? Process was not procedularized
? No documentation was provided to R&D for the change, therefore, her work was not reviewed – which could have caught this error.
[FONT=&quot]o [/FONT]Why? – Sales requested this change all through email.
? Customer specification was not thoroughly reviewed by Quality Control
[FONT=&quot]o [/FONT]Why? – Rushing
[FONT=&quot]o [/FONT]Why? – There is nothing in place to force the review of the specification, there is no documentation that a review of the specification was actually done.

Corrective Actions:
? Procedularize the Specification Review Process and retrain all employees in R&D, Quality Control and Sales.
? Process Engineer could review the customer specification during the process / formulation review phase. This is done prior to the job being produced.
[FONT=&quot]o [/FONT]Side Note: This is actually how the issue was discovered before a complaint was given to Sales by the customer.
? Update the QMF 29 – Quality Control Information Document – to include a sign-off section of who reviewed the customer specification. This will remind the Technician and Managers to review the specification.

Re: How Can I Respond to this SCAR?

NikkiQSM said:

I think a HUGE communication break-down started this snow-ball. While top management was aware of the Spec Rev Doc, I dont believe it was properly filtered down to the other employees.

Click to expand...

The communication breakdown may be your root cause. Writing a procedure, retraining on the process and requiring signatures are all fixing the current instance of the root cause, thus I would call all of this part of the correction.

So how are you going to make sure that the next time there is a procedural change it gets communicated to all affected employees? That is your corrective action.