Quality Management System (Core) Processes and Administration / Support Processes

[Michael Christie]

System Processes

This is the first time I have posted to this group, so be easy on me, please...I have been reading this and related strands for some time, and I feel the insane urge to jump in.

The main process you have to look out for is that one that starts with receiving a customer order and ends with final fulfillment, be it rendering a service or dropping some goods on their receiving dock. It's all one process.

The second process is the one you use to mop up the messes that are created along the way, and to prevent them from happening again. This is your continuous improvement cycle. I consider management review to be part and central to this process.

Everything else is a subset of these two processes.

Write procedures/flow charts to define these processes. Write work instructions where people need detailed instruction. Don't rely on "training" as a substitute. An important reason for documentation is to keep a level playing field. Everyone needs to be on the same page. Another important reason is that people tend to forget over time, and start to vary the process. This causes instability in the process, with unanticipated results. Your auditors need to be able to detect this.

If your registrar keeps sending over nit-picking jerks, have a serious talk with their management. You are the management representative. Take control of these people.

But most of all, keep a sharp eye on who your customer is. Internal as well as external.

 

[SteelMaiden]

Re: Agreed - except ....

Originally posted by Jim Wade
FWIW, Michael, I agree almost entirely with everything you wrote.

But I'd query just one thing.

You say "don't rely on "training" as a substitute [for procedures and work instructions]"

Exactly. Michael, you seem to have a pretty good grasp on the concepts. But I think that you can gain a lot by the training to eliminate some of the day to day repetitious stuff. If you develop a good training skills set and make sure that it is used and learned (competence), your people will all be doing the same thing and the auditors will not have a problem with it. Of course, there are some caveats to this method. It wouldn't work well in an industry with a large turn-over (IMHO) nor would it work well if the company has not developed a culture that supports the QMS. Of course, I am not talking about anyone heres company!

 

[Mike S.]

I think most seem to agree that training (by itself) and training supported with written work instructions/procedures are both acceptable depending on the circumstances (complexity of the task, ability of the people doing the work, industry sector, customer requirements, etc.). But I just began to wonder, as someone who has not yet faced any registrar autitors (only customer auditors), how stringently would a "reasonable auditor" (i.e. not a jerk who delights in finding NC's and nitpicking things to death) hold you to your written WI's/procedures in the following example where strict adherance to the order of operations would not adversely affect the result: Let's say you had a written procedure for measuring the density of a small piece of metal. The written work instruction says #1. Clean the sample by wiping with a clean cloth. #2. Measure the length to the nearest .0001" using calibrated micrometers. #3. Measure the width to the nearest .0001" using calibrated micrometers. #4. Measure the thickness to the nearest .0001" using calibrated micrometers. #5. Weigh the sample on a calibrated balance to the nearest .01 gram. #6. Calculate density using the formula blah blah blah.

Now, let's say the operator first cleans the sample (step 1) then weighs the sample (step 5) then measures width (step 3), then measures length (step 2) then measures thickness (step 4), then calculates the density (step 6).

In reality, changing the order of these steps would not change the end result, but would you expect an auditor to have a cow about this? I realize there are processes where strict adherance to the order of operations is critically important, but in an example like the one above any reasonable person doing the job would know the order of operations as I've noted it would not cause any problem, and IMHO it would not go over well if people on the work floor saw that the QMS that was advertised as "suited to our business" and "helpful to our business" etc. really did not seem to have any "applied common sense" associated with it.

Any thoughts?

Mike

 

[Michael Christie]

Right On!

When I say "don't rely on "training" as a substitute [for procedures and work instructions, I have in mind those companies that eschew procedures and work instructions and use "training" as an excuse for not having them. Keep this one case in mind:

Your valuable employee who has been doing that one critical job for years and no one else has a clue to what he/she does suddenly quits on Thursday, and that "BIG JOB" is due to ship on Friday, and widgits are piling up at that one station. The design engineer and process engineer quit years ago and the current ones haven't paid any attention to that task because they are busy somewheres else. What is the price of no work instruction at that point?

A properly established training program will have a written instruction. Right?

As to the question of details in a work instruction tripping an audit finding, list the tasks that need to be performed, and sequence them only when sequencing is a criteria. Make sure you state if the steps are sequenced or not. Also, involve the person performing the task when you are writing work instructions. Less chance of them varying the process if they are involved, especially if you give them the credit for creating the instruction.

 

[SteelMaiden]

Originally posted by Michael Christie
Right On!

A properly established training program will have a written instruction. Right?

Quite possibly, but there are just some jobs that are hard to write work instructions for, some tasks are easy enough to perform the steps, but they take a lot of practice to perform well. In an extreme example, I would never think to take up the high trapeze act at the circus after reading a work instruction. 1. grab bar with both hands 2. kick off from platform 3. acheive proper velocity in 3 swings. 4. release bar and rotate body three revolutions.........
I think not! Some jobs can only be learned through training and repetition. Define it in your procedures/process definitions and then document that the guy is competent. If you have a good training plan, you will make sure that you have someone available to fill in if something happens. I am absolutely fanatical when it comes to cross training people. Learn your job first, then learn someone elses so you can pitch in if the need arises. Once again, I think that it is all dependent upon the culture of your workplace.

As to the question of details in a work instruction tripping an audit finding, list the tasks that need to be performed, and sequence them only when sequencing is a criteria. Make sure you state if the steps are sequenced or not. Also, involve the person performing the task when you are writing work instructions. Less chance of them varying the process if they are involved, especially if you give them the credit for creating the instruction.

You are IMHO correct. I don't use step numbers except where it is absolutely imperative that things be done in a given order. I do use numbers for tasks, then bullet the steps to follow. If Joe decides to clean the micrometer first and then the standard and Jill cleans the standard first who cares. I am still going to have a calibrated or verified micrometer when either of them are done.

 

[Mike S.]

Originally posted by Michael Christie

Also, involve the person performing the task when you are writing work instructions. Less chance of them varying the process if they are involved, especially if you give them the credit for creating the instruction.

Michael makes an excellent point here. Wish I'd said it! It's always been my policy to have at least one (when practical several or all) of the users either write, co-write, or review and comment on any procedure/WI that I write. The benefits are many.

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As to the question of details in a work instruction tripping an audit finding, list the tasks that need to be performed, and sequence them only when sequencing is a criteria. Make sure you state if the steps are sequenced or not.

This makes alot of sense. I just happened to think of this being a potential problem and wondered how an auditor might react to that type of situation. In reviewing some of the procedures/WI's we have, there are some where the steps are numbered but performing them out of sequence would make no difference in the end result (as in SteelMaiden's micrometer calibration scenerio). I will try to remember to avoid unnecessary sequencing in the future, but I wonder how often I might accidentally let it slip unnoticed into our documentation. I hate to go back and change all doc's that are like that because I know it is providing no value to my company for me to do that, and so would those who saw me doing it. I don't need bad press (so to speak) internally about the goofy Quality guy wasting time on such "no value" stuff when there are real issues that need to be addressed. I guess I'll worry about it for awhile (another hour or so!) then decide I'll have to cross that bridge if and when I come to it unless someone convinces me it will be a big problem.

Mike

 

[SteelMaiden]

Mike,

You will be given plenty of opportunities to review and revise work instructions. If you know you would like to revise them, put them on a list - your own objectives, so to speak. As the work instructions need revising, go ahead and make your sequencing changes - audits, continuous improvements, upgrades etc. In my experience, the registrar's auditors are less concerned by the sequence in work instructions than the internal auditors. Not always, but usually.

I don't know how many work instructions your company uses, but your time is probably better spent developing improved systems than to sit there and revise work instructions for revisions sake. Also, you could add a weasel statement in your procedures for developing work instructions stating that sequence numbers are added for continuity of documentation and activities may be performed out of sequence as long as the required output is achieved.

 

[Mike S.]

Originally posted by SteelMaiden
Mike,

Also, you could add a weasel statement in your procedures for developing work instructions stating that sequence numbers are added for continuity of documentation and activities may be performed out of sequence as long as the required output is achieved.

SteelMaiden,

That sounds like a great :ca: idea! Thanks!! I like "weasel words/statements" -- not to degrade a process out of laziness, but to allow for the application of common sense and sound judgement by the people doing the work (which is often me!) without having to write a novel instead of a short document and to avoid unnecessary doc. revisions for minor changes. For instance, many of our processes have ranges for the variables that effect the result that are best considered on a case-by-case basis as the job is done. In these cases I try to either simply state the acceptable range ("...at a temperature of 140 to 160 degrees...") and let the operator make the call based on their knowledge and experience and/or use weasel statements like "or as approved by the Responsible Engineer". If knowing what setting or value was actually chosen is or could be important for a future analysis, the value actually chosen is recorded on the router, test worksheet, etc. (which is saved as a quality record) by the person making the choice.

I feel better already. Until the next time...

Mike