Handwritten Personal Notebook


We are developing our QMS for ISO9001 and I have a question. We are a sewing manufacturer and our sewers, during product training, will make handwritten notes in a personal notebook regarding the product. We have instructions in the form of a Bill of Operations and a drawing, so these notes are used in conjunction with those when needed. My question is do these fall under a controlled document situation? I can't think of how to control them and the result of getting rid of them could be a mess. They are specifically important to our non-English speaking employees. Ideas

Ed Panek

QA RA Small Med Dev Company
Super Moderator
The risk I see is person A works differently than person B based on their notes and interpretations. Thats probably an issue for control.

Can you create the instructions in two languages?


Involved In Discussions
Use their notes to create a good operating standards for the people on the shop floor and re-assess them constantly. Their input could be very valuable. Half of the job seems already done. It's fine to have same standard in 2 or 3 languages (as needed). If you seek controlled documentation to comply with clause 7.5.3 control of documented information, you must aim to achieve standardisation of operating procedures/work standards. Imagine there's a design change and how uncontrolled this could be in their notebook. Or if this notebook suddenly disappears? The risk is big therefore should be addressed.
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Super Moderator
The individual and not the organization and the difference between them is the question. The individual seems to have created help-aids for themselves as refreshers without organizational mandate, so "NOPE" there's no control issue here, I see that all the time........Now, if anything I'd look at that information as possible input into 7.1.6 Organizational Knowledge and managed as such.


Haste Makes Waste
I've translated Operator documents from English to Spanish in Word and Excel using the Translate feature. It translates to basic Spanish.
We had an Auditor who was bilingual who would proof read and edit the translations. Our plant had 3 different Spanish dialects that she would adjust the wording so it could be useable for all three dialects.

We were automotive so translation as is a requirement.

Dan Watson

Involved In Discussions
I guess I have always looked at a differentiation of SOP's vs personal notes. I have always said that SOP's are written to the level an experienced operator, and not a training document. An SOP has the key process steps and measures that (hopefully) keeps the operator's and defined process steps "in-line" (i.e., no major variations between operators). So, any personal notes would not be a controlled document in place of an SOP. I do agree that language differences be addressed. In a different life, I worked at a company that spoke both French and English. The SOP was broken into a French section and English section. It seemed to work.

Also, it depends on your management. Some just want documentation for audits and nothing else. The rest of the time it is usually letting operators go wild. In that case, variation goes wild too, but this kind of management only cares about making and shipping products. If it is wrong, issue an RMA and return the poor product. I hope your company is serious about process control.

I hope this helps.
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