Hello,
I desperatly need some help on how to write quality procedures and work instructions. Examples of each would be fantastic. I am a student doing a six week project to help improve a medical manufacturers Quality System, they have 35 employees, so any help would be greatly appreciated. I have only three weeks left so what do you suggest I can do?
The current system has a quality manual and all other documents are basically lumped together. Have spoken to several people in the company who say its just gotten out of control. Would like to be able to show them how they could write there documents in a clearer way and how they could be structured in a pyramid way.
Steve
P.S My project has now changed direction after the advice which has been given on this forum. The aim now is to flowchart the design and development procedure and then to write documentation based on this.
Any tips on flowcharting or the process approach and any useful links would be greatly appreciated.
Also what are the differences between flowcharting a procedure and the "process approach" ?
Last edited by Steve Pring; 14th August 2003 at 10:27 AM.
Hello,
I desperatly need some help on how to write quality procedures and work instructions. Examples of each would be fantastic. I am a student doing a six week project to help improve a medical manufacturers Quality System, they have 35 employees, so any help would be greatly appreciated. I have only three weeks left so what do you suggest I can do?
The current system has a quality manual and all other documents are basically lumped together. Have spoken to several people in the company who say its just gotten out of control. Would like to be able to show them how they could write there documents in a clearer way and how they could be structured in a pyramid way.
Steve
Hi, Steve
not understand your question clearly. do you mean this company has a ISO9001:2000 certificate but with poor performance on system running? your role is to help them for improvement?
It's too short time for 3 weeks to improve system performance. You know for some bad system, most cause was not against system self, mainly from people's problem, they do not have good awareness.
sometimes, it's problem on establishing quality system. If system was not designed for practical operations,a big problem,lots of waste.
My suggestions, talked with related person in that company, what they feeled on current documented system? then read/understand ISO9001:2000 standards, find the gap with current document.
basing on employee's competence. documented system could be simple. make sure you could link procedures in quality manual,link work instruction in procedures, link related forms in procedures/work instructions.
hope helpful.
I do believe we can give you a hand, but I'm not able to provide much in the way of examples, since all my stuff is in Swedish !!.
First of all I suggest that you ask questions about the separate procedures / instructions you have in mind in separate posts (rather than lumping them all together - which as you already noticed is not the best way to do it ). I'm certain you'll get help that way.
Secondly, it's usually a good idea to keep things as simple as possible and minimize the use of text by using graphics whenever you can.
All our procedures begin with the following three things: Scope, Purpouse & Responsibility. When you have them sorted out it's usually a lot easier to write the rest.
The "pyramid" structure you mention can be used, but there are other ways if it works better. The pyramid is basically
LEVEL 1 - QUALITY MANUAL (tip of the pyramid_
LEVEL 2 - PROCEDURES (WHO, WHAT, WHERE, WHEN)
LEVEL 3 - WORK INSTRUCTIONS (HOW)
LEVEL 4 - RECORDS (base of the pyramid)
What you can accomplish in 3 weeks is a good question, and will depend on exactly what is there already. Maybe you can start something and hand it off to someone else when you leave. I'd ask the people there what they feel is most in need of fixing to help them in their daily work. Get their buy-in. For example, maybe if they feel their work instructions are written wrong (what is written is not that they do), or are too confusing, etc. you can make a project of going over the existing WI with the folks that do the work or are in charge of the process, seeing where the docs. are wrong, and then correcting them and making them simpler via flowcharts, etc. But much will depend on what is there already. You can't perform miracles in 3 weeks.
__________________
Mike S. ("Gun Nut")
And they ask me why I drink....
The "pyramid" structure you mention can be used, but there are other ways if it works better. The pyramid is basically
LEVEL 1 - QUALITY MANUAL (tip of the pyramid_
LEVEL 2 - PROCEDURES (WHO, WHAT, WHERE, WHEN)
LEVEL 3 - WORK INSTRUCTIONS (HOW)
LEVEL 4 - RECORDS (base of the pyramid)
What you can accomplish in 3 weeks is a good question, and will depend on exactly what is there already. Maybe you can start something and hand it off to someone else when you leave. I'd ask the people there what they feel is most in need of fixing to help them in their daily work. Get their buy-in. For example, maybe if they feel their work instructions are written wrong (what is written is not that they do), or are too confusing, etc. you can make a project of going over the existing WI with the folks that do the work or are in charge of the process, seeing where the docs. are wrong, and then correcting them and making them simpler via flowcharts, etc. But much will depend on what is there already. You can't perform miracles in 3 weeks.
Mike:
Yes, but I would like to add the quality policy in there, too. Some people make that a part of the Q Manual (level 1), some don't. I tend to see the Q policy as being at the "top", but it could be seen as being "even" with the Q Manual, as well, I guess.
Just a thought,
We do not use a Quality Manual - it is our Operations Manual.
We show how the Company Goal aligns with the Company Mission Statement which aligns with the Quality Policy Statement, etc. etc..
IMO it is easier to see how the procedures, work instruction, etc. help support the chain going up.
It has also assisted in the integration process by combining not only the ISO-14000 and TS but it addresses the internal controls, hoshin, 5-S and other initiatives we have been assigned.
__________________
"What this country needs is more unemployed politicians." Edward Langley
I guess that as a student you have been given quite a direct instruction to 'sort out the companies procedures', with little else to tell you whats wrong with them, and why they need change.
The very directive to 'sort out procedures' is steeped in the ISO9001:1994 (and predecessors) mindset.
There is actually far more to quality than writing procedures.
The revised ISO9001:2000 standard has shifted fundementally from its predecessors. I imagine that you are in a 1994 certified company overrun with documentation.
ISO9001:2000 is based on the 'process approach' to management. The old requirements to maintain vast amounts of instructional documents is gone, primarily you have to identify and manage your processes effectively.
I suggest you identify the companies processes and how they interact (via process mapping), identify the process owners, have the management team decide on key performance indicators, and then set up some decent data capture and reporting systems to monitor process performance against these objectives.
You will find that process mapping to a reasonable depth (say 3 to 5 levels) will give you good graphical representation of your traditional text based procedures, and you may well find that they become naturally redundant.
So you will have purged the system of the onerous documentation, and set up a good system of real performance measures - the company will forever be in your debt !!
Process Mapping and Quality Procedures Examples
Hello, 
.
). I'm certain you'll get help that way.
Linear Mode
