Old QMS... NEW QM.. I don't know where to start

Colin

Quite Involved in Discussions
<snip....I would come up with some kind of summary of where you think you are now, and what the downsides/risks are with the current situation and what you plan to do and how and deliver to management. (Apart from anything else, it Covers Your Ass should anything go pear-shaped - ie,management cannot say 'we wasn't told'.)

Pick an area where you might get some 'quick wins' (or at least no major resistance!) and use that to pilot the new approach.<snip>

Very good point Jane, a couple of simplified flowcharts/procedures for a department where there may be a receptive manager can go a long way to starting to turn the system around.
 

John Broomfield

Leader
Super Moderator
Just to complicate things, one of teh companies i manage is a recent acquisition and their system is totally different, their QM quit and they have not replaced him, these also have a separate MD who you cannot pin down he is all over the world.. but this has to be my worse company because they have had ISO forced upon them and they retaliate at everything.. i want to avoid major NCR but at the same time i think that getting a couple from the external auditor will give them a reality check.. i am currently making a stance and refusing to bring them under the multi-site approval until they have a re-think BUT they are only interested in making money and not spending it so i doubt that will happen any time soon.

Chris,

Making money should not be at odds with managing quality. Failure to manage quality leads to huge losses as does wasting all the available money on verifying the products of broken processes. Everyone needs to understand this. :bonk:

The key at first is to focus everyone on getting their processes right. Make it known to your leaders that you are researching how to develop a process-based management system so it can be used to add value faster and prevent loss sooner while fulfilling the mission, conforming to the relevant standards and delivering compliance with the relevant laws and regulations.

Issue a Preventive Action Request to cover this initiative and to show what is being done to prevent future nonconformity. Include a plan to show how the organization will protect the integrity of its system while steamlining the documented parts of its management system.

You will find that for each operating company you with their leaders need to document at a high level what they actually do with their customers and suppliers to convert customer needs into cash in the bank. This is known as the core process and is best recorded using a deployment flowcharting package (not a slow and expensive to use drawing package).

From these core process flowcharts you can determine the key processes necessary to fulfill the mission that are unique to each operating company and those supporting key processes that can be shared across all companies in the group.

Work with top management and ask them to assign process experts to own each of the processes. Obtain a top manager (not you) who is willing to own and champion the actual process for "investing in continual improvement". You should own little more than the internal auditing process.

Agree with top management and have them announce the names, roles, authoriities and responsibilities of the process owners and the fact they will be working with you as the Group QMS Manager.

The process owners for example could be authorized to archive any process documentation that adds no value. Monitor their work to ensure they are not cutting too deeply. Engage the process owners particularly in addressing the interactions between processes. Their flowcharted process descriptions (new-style procedures really) will show the interactions between departments in fulfilling process objectives.

Now you are also alieviating your staffing problem. Also recruit cross-functionally to build a robust internal auditing team and multidisciplined problem solving teams to remove root causes of nonconformity from the system.

As you do this you will find the significant nonconformities. Feed them into the work of your newly trained and authorized multidisciplinary problem solvinf team.

After two years in the job, hopefully you are not perceived as being part of the mess and that you can rise above it and find an influential top manager to sponsor you and this vital initiative.

Best wishes,

John
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Such good responses so far. :applause:

Here's a summary of what I gather from the posts:

1) The QMS is pretty much a one-man job.
2) Having managed to maintain certification and market share so far, top management feels comfortable enough to simply change the way things are running.
3) There is very little synergy in the corporate QMS - basically a bunch of fiefdoms.
4) Over time, the system has become bloated and creaky - a Mousetrap Game of a system.

John P. Kotter has a couple of must-read books out there: Our Iceberg is Melting and The Heart of Change. In these books, Mr. Kotter conceptualizes and walks the reader through an eight-step organizational culture change process.

Clearly there's a need for change, but we have two questions:

a) What priority should we place on which system changes?
b) What message should we send to describe why a) is critical to our success?

In other words, you need to establish the vision: what your company's "iceberg" is, and why it is an important enough threat to require serious, immediate and resourced action. This is for you to understand before anyone else does.

I will use an analogy of a kid's messy room. I, the parent, go in there (well, I try but the door barely opens! so I am stopped at the doorway, just gazing in dismay) and am confronted with what looks like an impossible disarray. This needs to be cleaned up at once! Right? But it's not right for me to go in there and do it. I might throw out something important. And besides, he should do it. It's his room and his mess. He knows what he needs, what's garbage and he should take responsibility.

So, I launch into my passionate speech: "What a pigsty! This room needs to be cleaned at once!" And I get a blank look. I haven't clarified why it's important. The world is still spinning on its axis, and so far my little darling has managed to find his way around and excavate as needed to produce what he needs. There's no emergency for him. It's all opinion.

Or is it all opinion? There's plentiful data showing people perform better, and are happier, in a well organized environment. But my kid is not impressed with this data-driven argument - he feels fine, thanks. A more compelling message is required. Something will have to go wrong and "prove" to my kid that the status quo isn't desirable. He'll have to lose something with intrinsic or extrinsic value, or be stopped in a practical sense such as having no clean clothes to wear when he wants to go on a date with his new girlfriend. Then, since this cleanup is a gigantic task, he'll need some resources (trash bags, maybe some shelving) and lots of practical encouragement. A big job can't be accomplished in an hour. He needs to pace himself, but not lose sight of the end goal.

When the room is clean, it helps him to do something that helps turn the room into a different place. He could rearrange the furniture, maybe even paint the place and put in new window dressing. Something to make it clear that this "new room" is a more desirable place.

So: you're the parent, looking in on this mess and wondering what approach is most practical. Let's go back to my original list now. You can't do much about #1 yet. That's something that may need to be more of a result and less of a targeted effort. We'll come back to it.

For #2, you need to define the problem, the consequences and what they would mean to the organization and its members. Stick with the really urgent ones so far. Do a gap analysis. If there's a lack of documentation for your nuclear and pressure vessels and/or you have reason to believe they are being delivered with flaws that could get you in trouble, this is probably the best place to start. You will need to deliver the message of what is wrong, why it's important and who needs to do what to resolve it (a rough plan). The vision needs to be more compelling than "My dear, your room is a pigsty!" though that is true. The change needs to help meet the people's current objectives: producing and delivering reliable, profitable products and services to maintain market share and keeping regulators satisfied.

#3 is something you can't do much about, I fear. Stick to what is within your reach.

#4 is the kid's messy room. If cleaning the mess helps achieve the vision set out in #2, you're all good. But keeping in mind the extent the mess and its unclear impact on people's achieving their objectives, I'd pace myself and start by picking a visible, relatively simple project that can involve willing people and produce a clearly desirable outcome that can be celebrated. In this way you can hopefully spread the image that tidying up the place is a good idea, and that the people closest to the process need to be in charge of the cleanup because they will be the ones to enjoy its benefits and maintain the New Way of Doing Things.

I hope this helps! I have to run some errands now.
 

chris_gray1980

Involved In Discussions
WOW, WOW and WOW....

the responsed to my thread has far exceeded what i expected (not sure what i expected but blimey)

i have the up most respect for all of you, your knowledge it incredible..

Thank you

Reading through your posts i gather you are all more or less saying the same thing, its just now how do i tackle it, the filtering, prioritising, the organising, the analysis (no idea where to start with these i have not done any kind of gap analysis before, i know this is probably basics as far as Quality goes but i have only been in quality for a few years and the training i have had is through LRQA and that was ISO interpretation, New Quality Systems Manager and Lead Auditor.. that is all really and everything i am learning now is things that i am just picking up of my own back because there is no one who can really guide / teach me but i am gaining knowledge from a system that is a MESS :frust:.. i do have the problem that i cannot really ask for help within the group, if i do they will see that i am incapable of doing the job and that will effect everything i am trying to do, so i portray that i am confident and knowledgeable or i dont say anything, but i know this will trip me up soon :( ) :frust::frust::frust:

when i open up our quality manual and procedure manuals its just a massive jumble and im feeling SOOO overwhelmed i cant take it in or concentrate..

I have printed off all the above and i will try and digest what you guys and gals are talking about, i am suffering from information overload and with that i find i do nothing but hide and brush things under the carpet

BUT I DONT WANT TO, i want to TACKLE THIS AND BEAT IT AT ITS OWN GAME and as said before NOT BE A SLAVE TO THE SYSTEM BUT OWN IT

I would really like to thank you again, it has been so nice being able to talk to people like you all...

If you have any more hints or tips or even samples you can point me to please do so.. i will check out the books above, thank you..

I wish i could do and know what you all know :cool:

:applause::applause::applause::applause:
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Hi Chris, I'm glad we could help. You are in good company - we are pulling for you.

Maybe for starters you need a set of basic description of what happens in your facility. As QM you have the prerogative to ask people to list the simplified steps in their processes, because you are not clairvoyant and there is no USB cable that fits to your brain to tell you everything that happens there. The people performing work should start their list of steps with what they receive from someone else, and end with what they send to whom. In this set of steps they should refer to what procedure, SOP and/or form applies, and perhaps even the element number or group of elements in that procedure/SOP.

When you receive the lists, you can make a set of flow charts to help you understand what basically goes on and how it fits together. You might even decide this is a good approach to a quality manual, and replace the encyclopedic approach.

When feeling overwhelmed with data it may help to systematically list and evaluate all the worries. The objective is to get them out of your head and into a tool where they can be examined critically, quantified, prioritized, then planned for resolution as seems most practical.

The FMEA approach can be applied. I attached a Global Audit Tracking Log in the Critical Action Limits (CAL) for All Internal and External Audit Findings thread. The spreadsheet has an audit tracking log, but for this purpose I suggest looking at its tabs for Risk Definition and Risk Ranking. In the Risk Ranking sheet you can list the aspects of the QMS that bother you. You can adapt some of the Risk Definition criteria if it helps, but use the criteria you settle with to evaluate what's most urgent to attack and what the payback would be.

Remember my mentioning shelves in my foot-long post? The Risk Ranking method is like a shelving unit for your brain.

I hope this helps!
 
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chris_gray1980

Involved In Discussions
You are brilliant Jennifer, thank you and your very inspirational as well, i really appreciate all help and guidance (the similar and logical the better)

My feet haven't touched the ground since starting this job and i would like to take time to step back, relax and have a fresh approach.. for example today, i am looking at producing a supplier quality plan and my head is ALL OVER THE PLACE, i'm thinking about absolutely all sorts and not the task at hand so by the end of the day i will have achieved very little, i really need some help with focusing (something else i will have to google)

Thanks again for everything

HOLLY COW..... i have just looked at your spread sheet that has just blown my mind, i'm going have to really interrogate it and absorb, thank you your brilliant
 
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Jen Kirley

Quality and Auditing Expert
Leader
Admin
You are very kind. :D

Although I don't have ADD/ADD, I often feel as though I do. To deal with it, I have started using advice from web sites for adult ADD/ADHD people, such as:
  • Become a clock-watcher. Use a wristwatch, timer, alarm, PDA or computer—anything that keeps accurate time and is within your sight at all times. When you start a task, say the time out loud or write it down. Allot yourself limited amounts of time for each task.
  • Create a daily ten-minute routine. Attend to filing documents, processing daily mail, paying bills, and other mundane tasks on a daily basis for the same amount of time, and preferably in the same order. If you have a regular process to follow, you can be sure you aren’t missing something important. If you have only ten minutes, you will know when to stop.
  • Give yourself more time than you think you need. For every thirty minutes of time you think it will take you to get someplace or complete a task, add ten minutes.
  • Plan to be early and set up reminders to leave. Write down appointments for fifteen minutes earlier than they really are. Set up reminders on your computer or on paper to get yourself out the door on time.
  • Decide what’s first; prioritize. Ask yourself what is the most important task you need to accomplish, and then order your other tasks after that one.
  • Take things one at a time. Break down large, seemingly overwhelming projects or tasks into smaller, manageable steps.
You might find my Project Manager attachment useful in keeping track of things you have going.
 

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For what it is worth Chris, I had the same experience in my last job. We were getting by, the the entire system was overburdened with excess. It took me three years to continue with the 'old' system, while gradually rewriting and introducing newer, streamlined processes. In the end, I had completely rewritten all the procedures and processes, and an reviewed and rewritten most of the forms. Then I went back and essentially rewrote the quality manual as well. Now the system is finally revamped, and much more user friendly, which helps immensely with compliance.
It was a long slow process, but well worth it in the end. I know at this time , balancing the old system with new items as you do them is difficult, but using the old system helps point out where the improvements lie, so it is a valuable experience.
Of course if you have a marginal system that is failing, you are much more pressed for time, and sometimes a 'band-aid' is required just to buy more time. I did my share of patching old systems up before being able to finally replace them.
 
J

JaneB

when i open up our quality manual and procedure manuals its just a massive jumble and im feeling SOOO overwhelmed i cant take it in or concentrate..

... i am suffering from information overload and with that i find i do nothing but hide and brush things under the carpet

BUT I DONT WANT TO, i want to TACKLE THIS AND BEAT IT AT ITS OWN GAME and as said before NOT BE A SLAVE TO THE SYSTEM BUT OWN IT
Time to take a break then.

One thing that may help: don't try to ignore or run away from how you feel - instead, accept that your response is a very valid and useful piece of feedback. Feeling overwhelm/too complicated/help/want to run away? Take this as a very strong indicator of what is wrong with the system. (Not you.)

Learned this during years as a consultant - I eventually came to realise that every time I was feeling overwhelmed/helpless/horrorstruck by a situation, instead of worrying it must be me, I found that it was a very good indicator of the situation itself. Other people will almost certainly have this feeling toward the system also - they just won't admit it yet.

I don't know if I'm communicating this adequately. I'm trying to say - give yourself a break (literally and figuratively). Step back and 'let it mull'. Don't try to rush into action too soon. Remember, it takes a bit of time to analyse and plan and decide what to do (even just the next few steps!). You cannot (effectively) DO until you have PLANned. The system's been as it has for a while - it can stay as it is a little longer while you work out how and what to tackle.

You've had good training with LRQA. You have help here you can draw on.
And one of the reasons we all 'know what we know' is that we've probably all gone through similar 'oh, my Lord, where do I start???' situations. And lived through 'em.

PS. Thanks for the nice feedback. I enjoy helping when someone doesn't want to be spoonfed, is willing to do the work and even has the courtesy to say thanks. (Doesn't always happen).
 
J

JaneB

Forgot to say - it took me 2 and a half years with one client, working on very gradually replacing a godawful convoluted, incomprehensible and plain yuk system which no one paid any attention to (for very good reason) with a skinny little set of straightforward procedures as flowcharts, plus a few policies, and some clear checklists. Now, the owner loves the system! He hated the former thing, but had been browbeaten into that what was 'necessary' for certification by a so-called consultant (who wasn't). And yes, I had to do quite a bit of patching and keeping up some crap stuff in the meantime.
 
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