Question about Job Documentation Requirements

[Jen Kirley]

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.

If the same data can be kept electronically and your customer approves it and no regulation or body like Underwriters Laboratory forbids it, I see no reason why you cannot change your manual and procedures to call out this new means of keeping records. There are a limited few industries and types of products that still want handwritten evidence; unless I know what you are producing it is difficult to be more specific than this.

 

[somashekar]

If you have a NC written up by your auditor on this, take it up with your CB. If you do not find your CB responding in your favor, it is time you take a look at some better CB as a part of your continual improvement ~~~

 

[Jen Kirley]

I have seen people record approvals by using Outlook 2010 email with its voting button option. If people who approve these jobs use computers they must sign in on to do their work, the approvals can work in e-format because the email keeps a record of who approved and when. The voting button option can keep a log of all the approvers too, including remarks - it can also keep a copy of what was being approved at the time. The email can then be saved in a file and kept safe with backups. Many industries permit this kind of approval method - maybe, if you are permitted to use such a method, it would be faster than what you have now.

 

[xTourniquet]

If the same data can be kept electronically and your customer approves it and no regulation or body like Underwriters Laboratory forbids it, I see no reason why you cannot change your manual and procedures to call out this new means of keeping records. There are a limited few industries and types of products that still want handwritten evidence; unless I know what you are producing it is difficult to be more specific than this.

Thank you, you've been a huge help. I have a meeting with our quality manager on Monday to review this.

 

[xTourniquet]

If you have a NC written up by your auditor on this, take it up with your CB. If you do not find your CB responding in your favor, it is time you take a look at some better CB as a part of your continual improvement ~~~

Our auditor and CB are the same organization. Somehow, that doesn't seem right to me either.

 

[Jen Kirley]

Our auditor and CB are the same organization. Somehow, that doesn't seem right to me either.

This is a registration auditor? If so, he would be an employee or contractor of a Certifying Body - a CB. His business card might show their name.

To summarize:

As registration auditors, per the rules we don't get to say "You must use travelers/you must have handwritten signatures" unless it is because your manual/policies/procedures say you do, and/or unless it's required by a customer, a body such FDA or as Underwriters Laboratories (test data documentation expectations can get specific). That said, 7.5.1 does require controlled conditions so I would ask some tough questions if no instructions were available to production personnel because they were still going through approval.

You have the right to dispute a CB auditor's nonconformance but it must be done very soon after the audit ends and you need to be ready to present your logical, standard-based and data-supported case.

It would be nice to learn what you end up with. Please come back and tell us, okay?

 

[Kronos147]

We were told by our registrar that they were required by the ISO standard...

...ISO 9001:2008 does not require... inspection sheets.

Always ask the auditor to show you the requirement so you can implement corrective action and audit for effectiveness.

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

Ok, then THAT is the requirment.

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.

Change it! Justify the change in the change log (inspection checklists will be reviewed for correctness, completion, and then signed by the inspector... ).

If you have a NC written up by your auditor on this, take it up with your CB. If you do not find your CB responding in your favor, it is time you take a look at some better CB as a part of your continual improvement ~~~

Not if the auditor wrote it against an internal requirement.

Our auditor and CB are the same organization. Somehow, that doesn't seem right to me either.

Sometimes a registrar will use the certifying body's logo as part of their documentation to prove they are accredited, much like an organization will use the registrar's logo (under specific conditions) on their documentation. Perhaps this is what you are seeing?