Dock audits on Process FMEA, Control Plan and Process Flow Diagram

[Ragnar]

Hello! Looking for some help. During a recent audit the question came up with regards to the dock audit process appearing in the process flow dia. & control plan but not on the FMEA. Are there potential failures associated with dock audits and should these be captured in the FMEA and assigned RPN's? Any infor would be greatly appreciated.
Thanks:
Respectfully:
Ragnar.

 

[Jim Wynne]

There are potential failures in every operation or process. The expectation for our suppliers is that if it appears as a discrete operation on the flow diagram, it should be addressed in the PFMEA. In general, the potential failure modes for verification processes relate to acceptance of nonconforming material and rejection of "good" material. There might be others, depending on the circumstances. The standard Severity, Occurrence and Detection factors apply. You don't mention whether the audit in question was internal, by a customer, or by a registrar. If it was internal and your customers are happy with your PFMEAs, and you don't feel there will be anything gained by changing it, leave it alone. On the other hand, if it's a customer concern, you need to listen.

 

[karin]

FMEA and dock audits

Are there potential failures associated with dock audits and should these be captured in the FMEA and assigned RPN's? Any infor would be greatly appreciated.
Thanks:
Respectfully:
Ragnar.

Good afternoon, Ragnar.

In our case I put dock audits in the "actions taken" area as a reponse to issues we had with warehouse employees mislabeling product. We were doing dock audits on product but added labeling to the dock audit scope.

I'm attaching a copy of our FMEA. Hope it helps you out!!

Karin

 

[gaboring]

My 2 cents

We had the same problem in our audits, so we took out the dock audits in our control plans, process maps and routings. We changed our procedure and improved it when we began using dock audits as "Surprise" process audits. We found that dock audits were more effective if they were not part of the process flow. This way you can key on specifics for particular parts and processes and interchange the requirements for the dock audit. The only ones that were aware of a dock audit schedule were the GM and warehouse and quality mgrs. Give it a shot. You may find it to be less burdensome and more effective. It works for us and the auditor liked the idea of the surprise.

The only exception were products where the customer required dock audits for every job run and shipment.......these were obviously "problem" parts.
Just my 2 cents.

 

[Bill Ryan - 2007]

Hello! Looking for some help. During a recent audit the question came up with regards to the dock audit process appearing in the process flow dia. & control plan but not on the FMEA. Are there potential failures associated with dock audits and should these be captured in the FMEA and assigned RPN's? Any infor would be greatly appreciated.
Thanks:
Respectfully:
Ragnar.

Basically, if you have a process operation step called out in your Process Flow Diagram, it needs to be listed as an operation/step in the PFMEA and, consequently, the Control Plan. Whether you address Failure Modes at a particular step is another matter.

I agree with JSW05 that there are Potential Failure Modes at any process step but I may not, necessarily, address one at a "transfer" operation (for example).

Regarding Dock audits - we don't address them as a process step except in a "Pre-Launch" mode where we audit each skid of product. Once in a "production" mode, the step is removed from the PFD, PFMEA and CP. If you think about it, one of the "Golden Rules" of the PFMEA is that you need to assume product entering your processing step is "correct" with the intention being you "prevent or catch/correct" nonconformities at the operation they are produced. In that vein of thought, the only "Failure Mode" for a Dock Audit would be something to the effect of "Inspector rejects acceptable product".

 

[Jim Wynne]

If you think about it, one of the "Golden Rules" of the PFMEA is that you need to assume product entering your processing step is "correct" with the intention being you "prevent or catch/correct" nonconformities at the operation they are produced. In that vein of thought, the only "Failure Mode" for a Dock Audit would be something to the effect of "Inspector rejects acceptable product".

The "golden rule" you refer to doesn't logically apply to inspection activities, where it must be assumed that the condition of the product is unknown. Otherwise, there would be no point in doing the inspection This differs from manufacturing operations, where it is important to assume material introduced to the process is good, for the reason you cite.