My Quality Management Systems (QMS) Manual - Please review - Opinions appreciated!

[hokieman]

I have attached a copy of my proposed quality manual for anyone willing to take a look. Obviously I have removed any ref to names(I hope) The consultant my company retained prior to my arrival suggested a two-tier systems whereas the manual also contains the procedures and is accompanied by all relevant appendices, forms, etc...

Am I on the right track? Yes? No? Why or why not? Thanks everyone!

I do not know what the upload will look like but my layout has the coorect page breaks etc...

EDIT: Properties removed by request of author.

Marc

[Carl Keller]

Hokieman,

It looks pretty good.

You may want to regurgitate each section of the standard in each section just before the verbiage you have laid out. This will prevent the auditor from questioning anything that you have not made a statement about.

Otherwise, Just go through each section with the standard and ask yourself if you have covered each point in the manual.

Format and detail look good. You have kept it nice and to the point without a lot of "fluff" getting in the way.

Carl-

[qualitygoddess]

Always fun to read someone else's manual. Got a lot crammed into 11 pages. I only spent about 10 minutes reading it. Initial observations are that it looks pretty good. Again, I didn't check everything against the requirements in the standard, but I do have some feedback:

1. in 1.0, if you are going to have an exclusion, you are supposed to explain it. This is done in 7.3, so just copy and paste.........
2. overall, I'm not sure that the references to procedures is explained really well. Most auditors are looking for a reference to the procedure number while reading the manual. Since the procedures are included with the manual, maybe you could make that more clear in 4.0.
3. page 5, minor typo -- It says CNC and then NC. Think it is supposed to say CNC.
4. 7.2.2: I noted in other sections that the manual says who does the work. In 7.2.2, this is not said. Since the manual and procedures are together, I think you need this kind of detail. There may be other instances of this, and I did not pick up on those.
5. 7.6: says calibration within 3 days of due date. Don't know how many tools and gauges you have to calibrate, but don't miss the date! You may want to consider more time, like a week or calibrate within the month due.
6. There are several references in the document to Appendices A-C. Be sure those are accurate, esp. the one for management review, since the manual does not list the required inputs and outputs. These need to be in that Appendix!

Again, just a quick snapshot. I did not pull the ISO standard out and do comparisons section by section. I would have to charge for that!!

--Jodi

[hokieman]

Thanks for your time Carl! That's encouraging but I am confused over this two-tiered stuff. Every QMS I have seen has the manual, L2(procedures) followed by L3(WI). Our WI's are basically an operation sheet that accompanies the order. Granted our Co only has about 45 employees but am I trying to make more out of this than I should. Could it be this simple?

[hokieman]

Thanks QG! I will gladly pay you tomorrow for a hamburger today! Remember Popeye? I must eat more spinach to do ISO work....

[Carl Keller]

Hokieman,

There is no requirement for the levels of documentation.

as long as you have procedures for the required elements and have evidence to support you are doing what you say, you are golden.

You may want a bit more detail as you go through the other documentation and you ned to keep "polishing" a little, but I see nothing wrong with your current track.

You can show evidence the employees have been trained and document policies and procedures beyond that. Less is more in my book.

Carl-

[Wes Bucey]

Originally Posted by hokieman

Thanks for your time Carl! That's encouraging but I am confused over this two-tiered stuff. Every QMS I have seen has the manual, L2(procedures) followed by L3(WI). Our WI's are basically an operation sheet that accompanies the order. Granted our Co only has about 45 employees but am I trying to make more out of this than I should. Could it be this simple?

Let me reinforce what Carl Keller says by adding:
Every organization is different. Part of the difference is in how complicated or simple the processes which comprise the operation have to be.

Smaller or less complicated organizations can get by with one or two-page flow charts to describe their organization. Other organizations may need a 100 page manual and file cabinets filled with Procedures and work instructions to adequately describe their processes.

The ultimate test is if a comparative stranger can look through your Quality Manual and high level procedures (Level 2 in a three tier system) and understand what the organization does and how it plans to do it efficiently.

[hokieman]

Thanks for the info Wes!