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ISO 13485 Document Control - Document Changes - Needing Suggestions

love02eat

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#1
I am needing some suggestions on how to make changes to a work instruction that will keep the company incompliance with ISO13485. We are a manufacturing company that makes tubing for medical devices we are not a finished product we are not audited by FDA but we keep all rules in accordance. My dilemma is that different operators can finish the same job do to the fact that the product goes to different depts. to get finalized. Also accountability is not a strong point in this work place so someone is quick to say they didn't do that. (1.)There is already limited spacing for the techs to write all there measurements down but there can some times be mistakes and they correct them more then once. Also if the work order says they don't have to measure certain areas those spaces are blank. So the prior employee who created a work instruction just made it worse with using this rule 8.13.1 Use an asterisk ( * ) next to each error per person. The asterisk
will identify each error and who made the correction.
so on some docs you will 3 or 4 **** plus date and signature then she said no blanks all must put a line thru all blank data with N/A and initial and date it in the areas that doesn't get filled out. I need to know a better way for the techs to do there job with out extras and making internal audits task full because if they put the line and N/A but not there signature now its a noncompliance..



 

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yodon

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#2
Without knowing your processes, it's going to be difficult for anyone to give appropriate suggestions. And there are a wide range of options. For example, can you move to an electronic-based system with appropriate checks and balances? Another option may be to have an in-process Quality (peer) check before the operator signs off. Another method may be to just provide more space on the form!

You do point out some pretty serious issues. The biggest of which, in my mind, is the loss of accountability. The documentation should be set up to where it's clear who did what and why (including mark-up corrections).

(Not sure what "rule 8.13.1" is and why recording asterisks is a good idea.)

I don't know how helpful that was. Probably the ideal approach would be to get all the stakeholders together to (re)define an optimized process that captures the required information, has checks along the way to minimize the need to do corrections after the fact, and covers all regulatory and customer requirements.
 
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