Help Writing Quality Manual Small Startup

[Magus]

To all:
HELP, I have been reading the Cove forums and came several posts regarding writing a quality manual for a small startup company. I have just started been hired by a startup company in Pennsylvania. We are 1 Quality Engineer, 5 Directors, 4 Managers, 20 Design and Process Engineeers, and 5 employees. The operation is totally entrepreneurial with no documented quality system. My task is to put on several quality hats and quickly put together a quality system that is ISO compliant. We are a fabless wafer manufacturing operation. I will be the "Management Representative", the "Document Control Manager", the "Quality Manager".
Can you share a copy your quality manuals with me. I am looking for examples of the detail written into Level II docs (SOP) and Level II doc (Work Instructions). It seems like SOP and WI can often be rolled into one document. Am I missing a point of differentiation? It also seems a statement in the Quality Manual can suffice for an SOP. I fear that I am over simplifying. I have been reading the AMD quality manual and the example from Clinivation, Inc but still feel overwhelmed by the complexity of these documents as related to a small startup company.
Thanks,

 

[JRKH]

Keep It Simple

Magus,
First of all Welcome to the cove.
You've come to the right place.

A couple of questions.
1) Do you have a copy of the ISO standard including 9004?
2) What is driving the need for this? Are you looking to get registered?

Since you don't have a system in place yet, begin by mapping your processes. Then compare what your already doing to the Standard, looking for gaps (GAP analysis). Then you can start writing your manual while also working on filling in the gaps.

In my experience most QAMs are written in a format similar to the ISO standard, and references other docs as needed (SOP's) (ours is 13 pages).
DO NOT go into much detail. For 2 reasons, First you don't want to have to revise the manual for every change in a process procedure, and second your manual is sometimes sent to customers. The less detail the better.

As far a Level 2 Docs, The amount of detail is entirely dependent on what you need. Personally I feel that less is more. By that I mean that if your group is well trained in their tasks, and cross training has been done, there is less need for work instructions.

Each process will need to have some kind of procedure (SOP) that defines responsibilities, expected output, records, and a general flow. Here again, If you have well educated personnel (as it appears you do) then don't spell everything out. Keep it as general as possible.

Good luck and I'm sure you'll get great advise from others here.

James

 

[Miner]

JRKH raised some good points. A good guideline for the three tiers is:

• Tier 1 Policy should state WHAT the company does in general terms.
• Tier 2 Procedures should state WHO does WHAT (in more specific terms) and WHEN they do it.
• Tier 3 Instructions (SOPs) define HOW to do it.

If your system is very simple, you can combine Tier 2 and 3, but more complex systems need separate documents. A good quality manual should not exceed 30 pages at max. Most requirements only take 1-2 sentences of policy, no more than a short paragraph.

Try to keep procedures to 2-3 pages. If you include too much detail, you cannot locate what you need. That is the problem with including instructional material in procedures. Try to make it obvious which procedure to refer to for any given requirement.

Instructions work better if they include a lot of photos and short, action oriented statements. An 8-page written instruction will not be followed.

See https://www.talsico.com/process_picture_maps.php for an example of a good format.

Good luck.

 

[Howard Atkins]

Welcome to the cove,
There are some very good threads here which have samples of Quality Manuals attached.
Please read the threads to see that there are no correct answers, look at the examples and make up your mind.
Please feel then to ask us what we think.
For your sake do the resarch first and this way you will not only have an answer but understand it.
All the best

 

[Claes Gefvenberg]

The others already provided good advice, so I'll stick to wishing you welcome to the Cove

/Claes