Overhaul QMS or start over? How do you decide?

[MichelleD]

Here's a new probem (?), I just found out about 10 minutes ago that I own all the calibration logs, certificates, etc. and no one knows why the ISO Coordinator had them in the past.

Anyway, that was off the subject. I have to admit though we do have a couple of procedures/process that are amazing. They are just not linked very well with the rest of the system. The KPI's (Quality Objectives) are grea and everyone knows what goals they are working on in their departments. The procedure is set up with flow charts that make sense. But this is only a few out of hundreds.

Thanks for all the info I'm getting. My little brain is just clicking away.

 

[Stijloor]

Here's a new probem (?), I just found out about 10 minutes ago that I own all the calibration logs, certificates, etc. and no one knows why the ISO Coordinator had them in the past.

Anyway, that was off the subject. I have to admit though we do have a couple of procedures/process that are amazing. They are just not linked very well with the rest of the system. The KPI's (Quality Objectives) are grea and everyone knows what goals they are working on in their departments. The procedure is set up with flow charts that make sense. But this is only a few out of hundreds.

Thanks for all the info I'm getting. My little brain is just clicking away.

Hi Michelle,

With this new (and perhaps other pending responsibilities), it is time to renegotiate your salary....

Let us know what you decide with the system "under construction."

Stijloor.

 

[MichelleD]

Hi Michelle,

With this new (and perhaps other pending responsibilities), it is time to renegotiate your salary....

Let us know what you decide with the system "under construction."

Stijloor.

Did I tell you I was Six Sigma Coordinator, too... SOMEBODY HELP ME!!

 

[Wes Bucey]

Did I tell you I was Six Sigma Coordinator, too... SOMEBODY HELP ME!!

1. First, take a deep breath!
2. Second, get a beverage of your choice - I've been to Huntsville - you need to stay hydrated!
3. Third, forget about the current manuals and procedures for a little bit - we'll get back to them later because the odds say, in situations like yours, that most of the manuals and procedures are cobbled together from generic manuals, maybe to the point of merely replacing the name of the original organization with your organization's name. That means they have no true relationship to what your organization REALLY does!
4. Sit down with the production manager or equivalent and work out a simple outline of what the organization really does (Shh! don't tell anyone, but this will be the basis for your "process map.")
5. Next, flesh out the details for the outline (design and sell an off-the-shelf product? Then work out how the design gets made. Make stuff to customer's specification? Then work out how it gets from "conversation" to finished product in the customer's hands.)

The idea is for you and subsequently everyone in the organization to implement The Deming System of Profound Knowledge without invoking the Deming name!
(The point of the SoPK is well summarized in this article (http://www.thefarm.org/lifestyle/albertbates/akbp9.html))
Once you and the rest of the organization understand what it is you really do, then, and only then, are you really ready to conduct a "gap analysis" to compare your system to the ISO Standard. Comparing a raft of documents in your possession is useless if the documents don't represent what your organization really does.

It has been my pleasant experience to find most organizations which are currently profitable are already following most of the precepts of an ISO Quality Management System with one glaring exception - they rarely have a written plan they follow to the letter (most processes are just "imbued in the culture") and they almost never keep a systematic record of the actions they perform for later review and evaluation - meaning they also rarely have a system of continual improvement because they really don't know where they've been!

If you are lucky enough to find that is the case at your organization, your task will be limited to writing ("documenting") the things they actually do and creating a record and review (this means EVALUATE!) system with an eye toward future and continual improvement to improve the efficiency and profitability of the organization and, hopefully, improve the lot of the employees along the way. Everyone works better if there is a positive answer to the question, "What's in it for me?"

Oddly enough, all of the foregoing is the basis of implementing a successful Six Sigma and/or Lean system within a organization.

 

[Gary E MacLean]

Well said Wes, plain and simple - very understandable.

And Michelle, about all the "additional" duties and/or titles? Get used to it - your in Quality now. We are notoriously the "go-to" group. Everything that noone else understands ends up in "Quality." that's just how it is.

GMAC49

 

[JaneB]

Here's my suggestion:

Start as you mean to go on (I hope) - ie, by being inclusive, not exclusive.

Hence, do NOT go away by yourself and make these decisions. That's called the 'I own the system' approach, and is not 'we own this system'.

Ask for input - what do people want out of the system/s? What is wrong with the current picture? And what would the new picture look like? Ask management, obviously, but also ask others. What works well now (if anything)? What do people want to retain (if anything)? Where is it worst at the moment? What's urgent, what can wait?

Use the results from this to plan & prioritise. Get management approval to go ahead. Then, pick just one or two areas and try a pilot, using the new approach & new format. Use that to adjust & fine tune, if necessary.

Finally, start developing/redeveloping across the organisation.

(Oh yeah, you'll have gathered I favour the scrap (largely) and start again method. If it's that bad, it's a waste of time trying to modify it. Plus sometimes you can be blinded with 'what is' and miss what could be. )

But if you get it right, you'll be doing it with input & involvement, which is critical.

 

[QAlady]

Hi Michelle,

We are actually in the same situation right now. I also started a thread and cove is very helpful to me. I was able to come up with a roadmap where I started from checking / revising the procedures in my section (Quality assurance). I also conducted an employee survey to gauge the level of awareness and interest of people with regards to QMS. With this, I was able to determine how I could address the issues regarding QMS implementation.

The result of my survey shows that I need to start over again. I started having a one on one discussion with each manager regarding their objectives, procedures...etc. Now we are on the process of revising our procedures, wherein we do it through departmental discussion and after office hours to avoid interruption to office transactions. I also make sure that people are always updated on the progress on the accomplishments. I make sure that people will feel the presence of QA section.

I still need more help that’s why I always monitor the thread I started. I hope guys out there will help someone like me and Michelle to go through such difficulties. Thanks.

 

[Claes Gefvenberg]

Here's a new probem (?), I just found out about 10 minutes ago that I own all the calibration logs, certificates, etc. and no one knows why the ISO Coordinator had them in the past.

Anyway, that was off the subject.

Not entirely... You have a formidable task ahead of you, and it will require a lot of energy. Getting stuck in everyday tasks is liable to rob you of the energy you seem to have. Could you "outsource" this to someone else? Like: Who is performing the calibration anyway? The same thing goes for many of those "minor" tasks: Combine them, and you have a major time thief on your hands.

/Claes

 

[Coury Ferguson]

Michelle,

Wes has provided the very first step: Take a Deep Breath.

Now, let's look at your first question:

My boss does not know anything about ISO and has basically handed over the system to me.

The answer to this question is some what easy. Train/provide knowledge to your Boss (if they are willing to learn). You should not be the lone ranger here. Remember, it is a Business System.

The next question(s):

This system that is in place now is labor intensive. We have multiple quality manuals, multiple internal audit procedures, multiple corrective action processes, multiple management reviews, multiple management reps, etc. No one likes the system.

Labor Intensive is not they way to go. It should be "Process Based." Multiple Manuals/procedures become very confusing to the people of the organization, and the Internal/External Auditors. If no one likes the system, then make the changes that fit within the Organizational goals and directives. This boils down to "one system, one way" = consistency.

We don't have a documentation department (which is fine) but I am the keeper of the original copies of the procedures. They are all in binders all over my desk and the on-line versions are so hard to find that no one even bothers.

I guess this needs some organization. Do you have an IT Department that can help with the on-line stuff? Try to reduce the Binders.

The internal audits in the past have been done just to satisfy the standard.

I really hate to say this, but this is some what "normal" and the Internal Audit System is not used for the correct goal: To improve the Business System.

The good thing is that there are no time constraints as top management has decided to forgo the ISO certification from the registrar. And after seeing the past reports from the registrar, I can almost understand their reasoning. The system that is in place now has left a bad taste in everyone's mouth.

I understand Top Management's decision. How bad were the Certification Body's (CB) results? It appears that there might be an impasse and a gigantic wall that will have to be weakened, to effectively incorporate a Good Business/Quality Management System.

So I have to decide if I want to do a gap analysis and correct the system that's in place or start afresh (is that a word?). I know what my instincts are telling me but I would like to see what everyone else has to say.

Based upon what I have read about the System, I would first recommend that you forget/drop the "current" Quality Management System, use the standard, and perform a gap analysis. The results of your gap analysis should show that there are some/many areas that need improvement.

From that point, develop a flow chart of all the existing processes, get everyone, I mean everyone, involved in the Business, to brainstorm a new Business/Quality Management System; document the processes, develop, the Policies and Goals, define the procedures, have a meeting with everyone concerned, when there is a rough draft of the Business/Quality Management System get their feedback. Finalize the System, perform another Gap Analysis and determine where there might be other changes; perform an Internal Audit of the system, sit down with Top Management and review the results.

You have your work cut out for you. But remember, everyone is part of this development. Don't take this task alone. Use other resources of the Company.

This is my opinion.

 

[Gary E MacLean]

Of course, you need everyone's involvement, buy in, approval, acceptance, acknowledgement, committment, whatever you want to call it BUT if you give someone a blank slate and tell them to write down what they are doing your system will stay right where it is for some time.

One of the reasons your system is where it is right now is because of lack of knowledge or lack of involvement on everyone's part. Why is there that lack of... mentality? My guess, based on experience, is that everyone has their own thing to do, and a lot of it. They don't have time to do, what they perceive as, your job.

JaneB is right on the money in most everything she says, just don't count on or wait on your peers. That's not a negative statement and it isn't meant to draw criticism, it's just the way it is. If it wasn't that way you wouldn't be faced with the task at hand.

GMAC49