Question about Job Documentation Requirements

[xTourniquet]

Hello all, I just stumbled across this forum and am hoping you all can help with a debate the production team and I have been having with our registrar concerning production job documentation requirements.

Currently, our process requires the following:

1. All production jobs require at a minimum the following operations: "Issue Job Documentation", "Assembly", "Final Inspection".
2. Each job requires the following documents to be printed by the team leader/shop manager: "Assembly Work Instructions", "Job Traveler", "Inspection Checklist".

Here's where things begin to get interesting.

A typical production job produces anywhere from 1 to 1000 pieces. We have one "Assembly Work Instruction" and "Job Traveler" for each job, but one "Inspection Checklist" for each unit produced on that job.

Because "Issue Job Documentation" is defined as an operation on the job, the person issuing the documentation is required to sign every document certifying that he issued the documentation.

This isn't a huge problem for a production run of 1 unit, but signing 1000 pages is a huge burden on our already overtaxed production team. Often times, the time spent completing all of the documentation actually takes longer than the assembly of the finished item - causing our labor costs to essentially double just to fill out paperwork.

On top of all this, we have a very robust ERP that provides all of the documentation you could ever want related to what operator completed each operation. I went through the process change procedure to digitize everything a few months ago, but when the registrar came back for an audit they issued us a CAR, fined us, and threatened to pull our cert. I was told that digital quality records aren't acceptable because they must be signed in ink and "anyone could just guess your ERP username and password".

Any direction you can provide is GREATLY appreciated.

Thank you!

 

[Jen Kirley]

Welcome to the Cove!

You haven't said what your product is, or who your customers are to demand such record keeping. When your organization set it up, was it about customer requirements? Or keeping things straight in the software? Or regulatory requirements? Or did you write all this into your procedures for some other reason?

I do not know what these units you make are, so I can not understand why each one needs its own sheet. Can you do a sampling plan following a confirmed setup and 1st article inspection with calibrated instruments to approve?

The ERP sounds as though it could accomplish what you need beyond setup, 1st article, sampling and final acceptance inspection. From here I do not understand why an individual document is needed for each part.

Can you tell us exactly what your registrar wrote up when threatening to pull your cert?

 

[xTourniquet]

Thanks for the fast reply!

These production jobs can range from something as simple as a two items placed in a box as a "kit" that takes less than a minute to complete, to assemblies containing hundreds of components that takes weeks to complete.

We implemented the system as it was required on some contracts we wanted to bid on.

The guys on the floor don't complain about the sheets for the larger assemblies as it helps everyone remember what's going on and operators can quickly fill in for each other if one is out of work.

The problem really just comes down to the "Issue Documentation" signature requirement. I've got a guy packing up and completing units just as fast (if not faster) as the team lead can sign that he issued the job to the floor.

Not to mention the team lead and shop manager don't even know there's a job until I (engineering) release it to them. To me, that is the issuance of the documentation - not someone printing it and handing it to someone else.

Edit: Forgot to mention that I build the first article so I can document detailed work instructions with pictures, establish time standards, etc.

 

[somashekar]

I was told that digital quality records aren't acceptable because they must be signed in ink and "anyone could just guess your ERP username and password".

You are with some wrong registrar (auditor) and you have the right to question.
When your ERP is mapped in the QMS and there are effective controls there which is again documented and can be demonstrated, you do not stand to get a CAR .....

 

[Jen Kirley]

ISO 9001 wants an authorized person to release shipment, but nothing in that standard demands a handwritten signature. Your ERP software should include a means to control shipment only upon acceptance. I agree with somashekar: you have the right to dispute a registrar's audit nonconformance.

What matters is customer requirements. If the setup was made based on past requirements from an old customer, they can be rethought. If certain customers want something really special and you believe their fee makes the extra record keeping effort worth while, then do it - but nothing says you must have the same arrangement for everyone.

Issue documentation is another matter. I am wondering if articles are being made before the instructions are available to the production people and inspectors?

 

[xTourniquet]

The customer only requires that we have a QMS in place - they don't go into detail concerning job travelers and inspection sheets. We were told by our registrar that they were required by the ISO standard...

 

[somashekar]

Another "Blame it on ISO"
Seriously are you already certified by them OR in the process of a new certification ~~~

 

[Jen Kirley]

Your registrar isn't here to defend himself, but I can say with confidence ISO 9001:2008 does not require travelers and inspection sheets. That said, 7.5.1 does require production to take place under controlled conditions. And with short runs that usually means travelers - unless there is another way to ensure the items are being produced according to approved designs/plans. Does your QMS/manual/procedures/policy say you will do your production using travelers and inspection sheets?

 

[xTourniquet]

Does your QMS/manual/procedures/policy say you will do your production using travelers and inspection sheets?

Yes it does. We wanted to change it to provide for electronic data collection and recordkeeping, and remove the requirement for signatures. That's all.

 

[xTourniquet]

Another "Blame it on ISO"
Seriously are you already certified by them OR in the process of a new certification ~~~

We are already certified.