Document Evidence for One Piece Flow Processes

We have a process in which our routing is assemble item complete. The process/safety instruction is broken down into different steps by operator. We currently use six operators to complete this process. We use a work traveler to sign off by the last operator to show that steps have been completed. We received an Action Request from UL during our continuous assessment that there is no objective evidence that the first team member performed a go/no go check. We need ideas on how others are documenting one piece flow processes and showing objective evidence that inspection/test requirements are being performed.

[Marc]

You say you have a traveler which follows the part. Why not have the check listed on the traveler to be initialed by the employee performing the check? This is typically what I see.

Another possibility is a sheet at the station where the check is made on which the check is recorded with assembly ID.

I'm sure some others here will give their experience on this as well.

----- Some Marc Smith Thoughts -----

You might also want to take a good look at the check being made. Is there a reason why it must be confirmed as having been done? That is to say, is there a step down stream in the process where, if someone 'forgot', that a problem would be found/identified?

I am asking the second part as apparently you are doing the process OK and have seen no reason to record the results. From this,I assume the inspection/test is not on the (a)control (or other quality) plan. I have found in the past that UL can be so strict as to be brain-dead - so I always am wary of them. This is not to say UL is bad - just very, very strict and often their auditors have a very narrow paradigm. On the other hand often I go into companies where it is evident they are doing something correctly but they can't explain why they are doing what they do - so it's not always a registrar 'thing'.

My personal paradigm is that if you're inspecting or testing something (even a go/no-go) you might as well record it. But when I'm auditing I often find inspections/tests that are neither recorded nor is there evidence that it has been done. I start asking questions why.

You can have an inspection/test which isn't on a 'quality (or control or other) plan.

Example:

Switch for electronic assembly. At point of introduction to the assembly the switch goes through a go/no-go which is not recorded nor is there any evidence it is done at all. This test is described as a screen by the product engineer. The product engineer explained that the switch is again checked down stream during an assembly functional test. He could show me test results from down stream which showed no evidence of a bad switch getting through to the functional test in over a year. He also explained that the screen was simply not part of their product plan nor did they see a reason to include it.

As an auditor, I cannot tell them what has to be in their quality plan. If they want to do 100 inspections and tests which are not 'part of the plan', that's their business - not mine. Nor is it my business to tell them what should go in their quality plan. I have been in companies which make complex assemblies where the only checks in their 'plan' were receiving (a count and check of the PO against the packing slip was all) and the final functional. Yes - they had a number of in-process checks/inspections - some recorded and some not.

My point in this is to stress: DO NOT jump up and do something an auditor says because s/he is an auditor. It is your business. Can you explain what you are doing and why? That is the biggest factor.

The spec (ISO) says:

4.10.3 a "Inspect and test the product as required by the quality plan and/or documented procedures."

You can have lots of extra tests and inspections in addition to 'formal' tests.

Think first!

[This message has been edited by Marc Smith.]

We have a similar one piece flow. Our operators sign the traveler at the end of the stated process and inspections. The last operator signs for all suboperations that comprises the one major....ie "Step 3 Assemble solenoid and all documented inspection/tests" is signed by last operator at a final test stand operation. A total of 4 operators "assemble solenoids" This is just fine with our Registar.....BVQI.

DHillsburg,
How do you have this documented in your procedures?

[This message has been edited by Mitchell Medford (edited 08-24-98).]

I think we're missing a small point here, If the check isn't documented, then the operators are not doing what is said and thus what is said is not what is done, hence, non conformance. If the check is necessary, it should be documented at least in the work instruction.

Recording of in-process checks is not a requirement. It is a means to prove you say what you do and do what you say. but, there are other ways of doing this also.

My recomendations usually follow this line: If you need to make sure the step is completed, record it; If it is done as part of the routine and documented as part of the routine, then proof is in the observation and repitition; If it is critical or a object for traceability, record it otherwise use recording as a means for discipline <sp>.

I know it sounds costly but if a go/no go fixture can b built into an automatic calcaution device the quantity of conforming and non-conforming checks can be tabulated electronically at any given point in your value stream. I know that precison machining process require this check to be in place before the product can continue through the process.

[Sam]

I would evaluate the process; Do you really need the checkpoint,Can this step be elimated or made a part of the process.
It has been my experience that documented inspection results within a "one piece" flow is not practical. Handling paper with the process defeats the purpose.

[David Mullins]

Dear MM,

Yesterday I resisted, today I cannot.

Don't just create work for the sake of compliance with some requirement - that is what gives quality a bad name.

Poka-yoke the process to avoid additional work for the operators.

Get imaginative.




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