Steps to Complete Quality Control Plans and Work Instruction

[dbproject]

Hi,

this my first inquiry here in this great an beneficial fourm

1- I need to know the steps to create procedures (or control plans) / work instructions specify requirements for operation, inspection, testing, gauging, production and start-up approval as well as product, process and tooling changes, with recorded results
2- what's the process controls? and what's it for?and what's the difference between control plan & process control?

3- will I make a FEMA for products failure only or for processes, equipment and labor as well?

I really appreciate your help

thank you very much

 

[harry]

.................. 1- I need to know the steps to create procedures (or control plans) / work instructions specify requirements for operation, inspection, testing, gauging, production and start-up approval as well as product, process and tooling changes, with recorded results
2- what's the process controls? and what's it for?and what's the difference between control plan & process control?

3- will I make a FEMA for products failure only or for processes, equipment and labor as well? ................

Welcome to the Cove.

Is there any particular standard (ISO or others) that you need to comply?

................... 3- will I make a FEMA for products failure only or for processes, equipment and labor as well? ..............

I suppose you are referring to FMEA - are you in automotive?

 

[dbproject]

Hi,

Thank you harry for your reply
ISO 9001 is the standard that I need to follow, I need your help with the points in my first post
I am in feeding industries that produce injectors , bolts and many others and yes, I mean FMEA it was a typo

I really appreciate your help

 

[harry]

Refer to ISO 10005: Quality management systems -- Guidelines for quality plans

ISO 10005:2005 provides guidelines for the development, review, acceptance, application and revision of quality plans. It is applicable whether or not the organization has a management system in conformity with ISO 9001.

ISO 10005:2005 is applicable to quality plans for a process, product, project or contract, any product category (hardware, software, processed materials and services) and any industry. It is focused primarily on product realization and is not a guide to organizational quality management system planning.

ISO 10005:2005 is a guidance document and is not intended to be used for certification or registration purposes.

 

[smryan]

dbproject,
ISO9001 gives you certain things that are necessary to have (work instructions etc.) but there is no specific form or format that is required for most of it. 10 different companies can have 10 completely different ways of meeting the ISO requirements. The key is figuring out what style or format will work best for your company. Or what you already have in place that already meets some of the ISO requirements.

If you are talking about FMEA then you are going above and beyond ISO 9001 requirements. Perhaps you have an automotive customer who wants a PPAP submitted? Then there are some specific forms - that customer should let you know specifically which ones they will require.

In general - as we have applied it - FMEA are done on a product. First the Design FMEA - trying to error proof the product itself in its design phase. Then the Production FMEA - error proofing all steps in the production of the product.