Hi folks.
I am going into a meeting with the Prez in about an hour. We are in the process of preparing for 17025 accredidation. I have been given to GREAT opportunity of creating a new QA system. My problem is this. The Prez believes that the manual should be written before the procedures.
Your thoughts?

I'm curious, do you not agree with him? The procedures should reflect the requirements set forth in the QMS, as such, I think it would be a nice change of pace to be able to author a QMS and then procedures from the ground up. Sounds like a great opportunity to really make a lasting contribution to your company. :D

If the Prez says so, why not? It might help to focus on some areas which need it! It's not really the order in which documentation is created, rather the way you go about creating it, the content and the value it is to the lab.

Does the Prez have a solid background (education/training) in why you're doing this?

It also depends on the content of the Q manual. If you're going to simply take the 17025 standard and turn it into your manual, as so many have done before, then you might want to rethink the whole thing........

If the Prez says so, why not? It might help to focus on some areas which need it! It's not really the order in which documentation is created, rather the way you go about creating it, the content and the value it is to the lab.

Does the Prez have a solid background (education/training) in why you're doing this?

He is a very intelligent individual with VERY demanding needs!
The reason I asked the question is that it just makes sense to me to know what our procedures are so we can accurately refer to them in the manual.

Quite so Andy....that's why the opportunity seems like such a pleasant change of pace. You can completely avoid those kinds of mistakes, because once an organization adopts bad habits (poor QMS design) you spend twenty times as much effort to make corrections and improvements.

Well, you have given me confidence that the Prez and I can work together without bloodshed!
Thank you all so very much:thanks:

Mo

I'd say start with in general terms and work towards become more specifc. I usually work in the following order: start with a very general overall process map, then quality manual, then procedures, and finally instructions (as necessary).

It will matter if you don't know all the procedures you will have.

My method has been to write the manual as procedures are written. The manuual may be started early, but it cannot be completed (or will under go multiple revisions) until all the little stuff is complete.

I agree with Marc. :agree1: The manual should be a synopsis of controls that are set out in procedures. You can start with the structure, element by element, but by writing the manual to describe what processes do you are avoiding the "Training shall be done" approach to the manual.

Do you already have a quality manual for general systems?

If you do, can the 17025 system elements be added in? After all, many of them are bound to be similar to ISO 900X etc.

I agree with Marc. :agree1: The manual should be a synopsis of controls that are set out in procedures. You can start with the structure, element by element, but by writing the manual to describe what processes do you are avoiding the "Training shall be done" approach to the manual.

Do you already have a quality manual for general systems?

If you do, can the 17025 system elements be added in? After all, many of them are bound to be similar to ISO 900X etc.
That is exactly what I am trying to avoid, Jennifer. I want to ensure that we our processes and procedures are functionable and effective before getting into the "meat" of the manual.
Yes we do have a general QA system but it has been developed and approved for the nueclear industry. We want to keep the two separate

Okay Moira, do you know why your president favors writing the manual first?

I would advocate writing the QM first as it should lay the groundwork for the entire system. Everything should flow downward in increasing detail from there. Think of the QM as your top level document of the entire system. The flow should be as follows: Quality Manual > Top Level SOP's (sometimes called Quality Policies) > Work Instructions > Forms, Logs, Worksheets, etc. The QM should essentially reiterate everything in the applicable standard but be tailored to your specific organization. Ideally you don't want to be so literal as to keep repeating the word "Shall" over and over. It should be written in the PRESENT tense. For example: "XYZ Corporation establishes and maintains procedures for...etc." The top level SOP's then describe WHAT your company does in order to comply with the various points in the applicable standard. The Work Instructions tell HOW various operations are performed. The forms and other lower level documents then capture raw data and when completed become RECORDS that provide OBJECTIVE EVIDENCE of compliance to the standard. Writing the QM in the present tense indicates that you ARE complying rather than you SHALL comply or WILL comply which suggests that it may not be happening until further out in time. Then all you have to do is make everything you say that you're doing in the QM come true. Of course that's much easier said than done but in the end you should be fully compliant and be able to hold up against the most rigorous audit. That's just my two cents worth. Good luck!

Jack

Okay Moira, do you know why your president favors writing the manual first?

Well quite honestly Jennifer, it is beacuse he is a power freak and a Micro Manager. I just got out of my meeting with him and discovered he had all my QA folders open on our server. He was "tidying" things up. At this writing, my palms are sweating thinking about all that he has "un-done"!

Well quite honestly Jennifer, it is beacuse he is a power freak and a Micro Manager. I just got out of my meeting with him and discovered he had all my QA folders open on our server. He was "tidying" things up. At this writing, my palms are sweating thinking about all that he has "un-done"! Ah, no... :mg: What was in those folders? Not audit reports, I hope, or even notes. Those things should be write protected. Do you know how to do that?

Yes I know how to do that, but with only 6 of us in the company, he insisted on having "dual" control over documents and records. Thankfully I am just beginning to amass 17025 documentation so it may not be as big of a problem as could have been. I just came out of his office again and told him how upset I was and to PLEASE leave my files alone. If he has a suggestion, ok, but let me make amendments.
Back to original post. I am of the thought that we need to document what we do in the form of procedures so we can then compare them to the standard. But if you folk don't see a problem with me doing it the way the Prez wants me to, I will give it a whril!

I guess I would argue that it's the chicken or the egg scenario. The advantage of writing the manual first is that it can act as a blue print for the entire sytem. It's also worth noting that these days audits are virtually always conducted from the top down, not the other way around. It shouldn't matter that you don't know what or how many procedures you will have because the QM by its very nature should be broad in scope and shouldn't be getting into the nitty gritty details of how day-to-day tasks are performed. I've been through two full scale ISO audits and have also conducted audits and I can tell you that I've seen ISO certified organizations whose QM's did nothing but reiterate the standard save for a few words. The fact is some people write their QM's for no other reason than to fulfill the requirement. I would make one other suggestion. A QM can be a single document or a series of documents. By using the latter approach you can essentially say that you've revised your quality manual each time you revise one of the top level SOP's that comprise it. The advantage of this is that you end up with a QM that's a living document which is much more in keeping with the spirit of the standards. In my opinion at least that's FAR better than a big honking doument that gets written once only to sit on a shelf and collect dust for three years until your next audit is due.

Jack

Thank you Jack. You make some VERY good points.

That is exactly what I am trying to avoid, Jennifer. I want to ensure that we our processes and procedures are functionable and effective before getting into the "meat" of the manual.
Yes we do have a general QA system but it has been developed and approved for the nueclear industry. We want to keep the two separate

I question the need, or even the advisability of having two separate quality systems in a small company. This can lead to confusion on the floor. Since good quality management is pretty much the same regardless of industry, I would keep the system documents unified and specific differences in lower level procedures.

Geoff Withnell

We are only keeping our existing QA system functionable until after our accredidation and then it will be obsolete. We are not a manufacturing company, so there is no confusing production people.
Our exisiting system complies to CANZ.299. A very old and stringent standard. It will not make me sad to see it go!