Manufacturing Process Work Instructions vs. Work Procedures - Differences?

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sas1965

Can you please explain what the difference between Work Instuctions vs Work Procedures? I need to write both for each of our manufacturing processes.

Thanks
sass :o
 
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sas1965 said:
Can you please explain what the difference between Work Instuctions vs Work Procedures? I need to write both for each of our manufacturing processes.

Thanks
sass :o

Generally speaking, procedures are sometimes called Level 2 documents and address things like "who, what, where, and when" and work instructions are sometimes called Level 3 docs that address "how".

Example: Procedure says the QM will control calibration of measuring equipment, it will be done every 6 months, it lists the types of equipment covered, etc. and the WI explains how to actually calibrate a micrometer or o-scope, etc.
 
In keeping with Mike's example - here is our procedure (who, what, where, when) and a couple of our calibration forms - which includes the instruction (how) for the specific type of instrument. I should mention that section 3.7.2 D is making reference to a picture that I manually inserted on our controlled hard copies - it's not there in the electronic document.
 

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sas1965 said:
Any ideas on writing work instructions/procedures on handling & storing PCB's

sass

Start by writing a step by step work instruction.

Or.. Start by writing a 10,000 foot overview procedure..

I will say this though.. in the ISO/TS-16949 world.. we supposedly only need a FEW procedures, and then document the work instructions as needed.

Back to task though. Interview the folks that do this every day. Get their thoughts on how to handle and store PCBs. Check with your environmental guy/girl to see what regulatory information needs to be included as well.

Organize, and make the content read smoothly. Remember, we are writing for the person doing it, but.... we also need to protect for the future by writing it so that the person NOT doing it can understand it just as clearly.
 
I would like to ask if somebody can tell me if there are different kinds of Manufacturing process contract?

What I mean with "Manufacturing process" is : we have our own formula of a medical device, we also have a brand name which is our own and we would like to sign a contract with a manufacturer who will produce the above medical device.

Thank you in advance for your assistance.

Kapitana
 
Thank you Ms. Spears. I'm retired Quality Engineer and way out of date? I've been asked to help put a Quality Manual together for a small company (they aren't interested in ISO approvals) trying to be more competive. I know the hierarchy of the controlled documents, what I'm having forgetfulness or being out of date is do all "I'm working on our document control procedure" does "Work Instruction" have to be signed? In my day, I don't think we had to sign a low level document? Thanks for your help, Tim, Accroman
 
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