Quality Manuals and Quality Plans - Whats the difference?

[JaneB]

dgreen07,

Going back to this quality plans and manuals, two weeks back i have finished a 40 pages quality manual and show it to this consultant who happens to be the one giving us the certificate (registrar), his team to be exact.

Yikes. Do you really mean that the consultant is also to be your auditor??? This ain't allowable & would be a breach of impartiality.

I like the relative simplicity of the procedures in the Quality Plan, & agree with his reported comments about removing lots of text.


I note you talk a lot about what 'he' wants to see. What do you want to see? Does what he wants work for you?

 

[jerzki]

JaneB,

Thanks for the comment and I appreciate it good. U were asking what do i want to see. The procedure is simple in this way, but the concept of management here in this company is quite having too much text that looks like a big binder book because this is what the old writers have infected in their mind. I am a new guy here and i should say, occupying only a small space in the nature of my work, but i wanna do this right not just by just writing things but improving things for the company, I really want this company to be a certified ISO company and I believe thats my challenge to input this to the management. My past experience in ISO was way back, the 1994 version ( ISO 9002 ) and occupying only a section of that company but here, I must think of all things about ISO.
Perhaps anyone out there could lend me some ideas, coz this consultant is urging me to finished it all at once and already committed to the management certification by june of this year.Is it possible and allowable by the standards?
Thanks again folks..and God bless you all.


jerz

 

[dgreen07]

Jane wrote: "No, it is not..."

Here we get into the age-old Tech Writer's refrain, "it depends".

...on what your management wants,

...on what your consultant advises.

In our situation, we _are_ allowed to use the same company for pre-assessment and formal assessment. And in our particular situation, our management proposes to use the ISO standard as a model but not necessarily to commit to pursuit of formal registration -- at least not at this time.

I've seen samples of quality manuals that are in a 2-sheet 11x17 format with very small print, a detailed business process diagram and some minimal text. The authors say that their documents have been accepted by their registrar, so I'm intrigued and drawn by this idea but I would not proceed without management buy-in and preliminary thumbs-up from some auditing authority -- maybe our FDA auditors.

Our management has not had the benefit of ISO training; it's budgeted for this year but the budget hasn't received approval yet. Even after they've been through a one or two-day course, I don't expect that they're all going to be experts (or champions). We're just starting to come out of the "shelfware" culture into one of actually using up-to-date documents (and keeping them up to date with actual practice). LOL, there's a whole separate topic!

I've just addressed the use issue of the "restatement" quality manual by creating a detailed index for the thing. Gosh, I hope I don't have to do that again any time soon! But it's done, and it will help -- especially when I get into my summer project of eliminating repetition/redundancy so I can single-source the entire manual. And when I said detailed, I mean painfully detailed, so anybody should be able to discover at a glance if the topic they're looking for is covered by the manual - whether they've been through training or not.

Quality plans are written here at the process level, almost always including an overview flowchart that shows where the process starts, where it ends, and where it connects with other processes. The Quality Manual holds a flowchart that shows the top-level business process flow and how the individual processes connect.

Looking at the business from a process perspective -- and looking up from the little piece that a person does as their daily task to understand the overall picture -- and defining co-workers and management also as "customers" -- are all part of the culture change we're undertaking.

If a company's overall training and understanding of ISO is more sophisticated, their quality manual can certainly also be more sophisticated. And I'm looking forward to a good examination of the proposed 2007 ISO changes.

So....it depends.

dgreen07

 

[Helmut Jilling]

The Quality Manual is a restatement of the standard with pointers to procedures, work instructions, forms, and supporting documents that provide more details about how you meet the requirements of the standard.

I've looked at the one and two-page quality manuals and I like them but I'd sure have to think about it a lot before trying to do that here. A few people think they know something about ISO but I'm the only one with any training or active experience with it.

Quality Plan is a product or service-specific work order that specifies how you meet the requirements of the customer contract.

In our food packaging plant, the QP is called a "placard". It is a laminated 8.5 x 11 sheet, 2 sides, and references a related "pallet pattern" for packaging.

Work instructions are organized by process, broken down farther by operation/workstation so that one or two-page instruction sheets can be posted at the point of use. For instance:

Bouillon wrapper room:
overview (process map with pointers to instructions and record forms)
setup & startup
wrapper machines 1-8
how to change wrapper rolls
how to change heat tape
inspection
emergency shutdown
non-emergency shutdown
light cleaning
medium cleaning
heavy cleaning

Dgreen07

It sounds like you are off to a useful beginning. If you want some help with keeping the system simple and useful, let me know. We have a particular focus with helping managers understand the benefit and value of applying ISO.

 

[JaneB]

Jane wrote: "No, it is not..."

Here we get into the age-old Tech Writer's refrain, "it depends".

...on what your management wants,

...on what your consultant advises.


So....it depends.

All very true, and I agree.

But if your reference to technical writer indicates experience in same, then you'd know the importance of how language is used.

I took issue with - and dispute - a blanket statement about what a quality manual 'is'. You didn't say a QM 'can' be such & such or 'one model of a QM is to (do such & such)...'. You said: it's this. Not so.

A wall can be built of bricks.

But to state definitively that 'a quality manual is a restatement of the Standard' is about as 'true' as saying that "A wall is built from bricks."

While ISO 9001 is definite about certain things that must be included in the QM (or referenced by it), it very definitely does not prescriptively define what a QM is or shall be. And if 'ISO' hasn't... do you really want to go there?

Hence, a QM can be - and is! - many different things in many different formats according to factors which include the needs of the company, the preference or familiarity of the person creating it, and yes, their skill (or lack of) in technical writing.

It's one of the things I feel strongly about (had you guessed?) You see, I've seen so many sheer bloody awful things purporting to be 'quality' manuals, and I know very, very well that a/they don't have to be awful and b/they don't have to restate the Standard. You can choose to do it that way, but there are other options. I also feel extremely strongly that your QM should make sense to the people who use it (never be written for an Auditor) and should add some value to the organisation. But enough about my strong feelings.

As hjilling said, sounds like you're off to a good start. But do focus on keeping it as simple as possible & useful.

 

[JaneB]

JaneB,

Thanks for the comment and I appreciate it good. U were asking what do i want to see. The procedure is simple in this way, but the concept of management here in this company is quite having too much text that looks like a big binder book because this is what the old writers have infected in their mind. I am a new guy here and i should say, occupying only a small space in the nature of my work, but i wanna do this right not just by just writing things but improving things for the company, I really want this company to be a certified ISO company and I believe thats my challenge to input this to the management. My past experience in ISO was way back, the 1994 version ( ISO 9002 ) and occupying only a section of that company but here, I must think of all things about ISO.
Perhaps anyone out there could lend me some ideas, coz this consultant is urging me to finished it all at once and already committed to the management certification by june of this year.Is it possible and allowable by the standards?
Thanks again folks..and God bless you all.
jerz

If the consultant has already committed to management, you might want to be careful about standing - or being see to stand! - in the way of that.

Re. getting it right - often it takes a company a while, perhaps some months post certification to tweak and fine tune & adjust their system to make it work better/suit them/fit better. Don't try & get it perfect - it just has to be good enough to get through... then you immediately start improving it! Don't forget that CI is part of the whole thing.

I'd urge pragmatism. Ifyou have to do some of what the consultant urges & management expects to get there... so be it. Then after a while either you'll realise the consultant knew better than you thought... or you'll realise that you can do it more easily comme ci, rather than comme ca... so you improve & adjust, & simplify. (Or add more detail... it doesn't always go the same way.)

 

[MsHeeler]

In the .pdf files here they have a great generic quality manual. It just restates the standard.

The only thing that you really need to do is add your company name, your quality policy, and the names of your procedures that answer the sections.

I made our new QM in a day!

BTW a big thinks to who ever posted that!!!

MsHeeler

 

[Helmut Jilling]

In the .pdf files here they have a great generic quality manual. It just restates the standard.

The only thing that you really need to do is add your company name, your quality policy, and the names of your procedures that answer the sections.

I made our new QM in a day!

BTW a big thinks to who ever posted that!!!

MsHeeler

I agree it probably made it quick and easy...but, how much value did you get from that approach? What is a QM worth to improve your company, if it received no real thought, other than inserting names? There is a lot more to an effective system than that, in my opinion.

 

[jerzki]

Thank you all guys,

Thank you for your comments and i believe all of these will be helpful enough. Actually, i have prepared both necessities for my management the bloated texty manual and this simple one that makes it easy and i believe would add value coz I have recently added some product realization process flow and interaction on it. It is very easy to know and follow in every aspect of the organization, but going back il let them choose which one is which and as for me i believe i have shared my responsibility and the ball will be on their hands now. But this one thing bothers me, I have written this manual in the top level business process ( a flowchart ) then referencing to quality plan ( a divisional processes ) then referencing to company general procedures ( as standard procedures ) down to departmental procedures ( as operating procedures ) and work instructions ( some work instructions , generic for all divisions, e.g document numbering system ) , my question is , is this allowable? Sorry if i may sound redundant , just wanna get some second opinions coz i have prepared it that way.

thanks in advance and God bless you all.


jerzki

 

[Helmut Jilling]

Thank you all guys,

Thank you for your comments and i believe all of these will be helpful enough. Actually, i have prepared both necessities for my management the bloated texty manual and this simple one that makes it easy and i believe would add value coz I have recently added some product realization process flow and interaction on it. It is very easy to know and follow in every aspect of the organization, but going back il let them choose which one is which and as for me i believe i have shared my responsibility and the ball will be on their hands now. But this one thing bothers me, I have written this manual in the top level business process ( a flowchart ) then referencing to quality plan ( a divisional processes ) then referencing to company general procedures ( as standard procedures ) down to departmental procedures ( as operating procedures ) and work instructions ( some work instructions , generic for all divisions, e.g document numbering system ) , my question is , is this allowable? Sorry if i may sound redundant , just wanna get some second opinions coz i have prepared it that way.

thanks in advance and God bless you all.


jerzki

Yes, it is allowed, as long as a normal employee can follow the links and find the document he needs.