Different "levels" of quality planning and the related documents

[KatK]

OK OK...I know that ISO9000:2000 is all the rage, but I find myself in a bit of a situation and need some help!!! We are registered (since 1998) and our ISO coordinator has left the company and we know find out what a mess we really have! :mg: We've been trying to go through the procedures and reduce them to bare minimums (since they've been completely overdocumented and not followed at all to date). So there's my sob story...now for the help...Quality Planning!!



After reading through ISO 9004, and 10005(??), it seems to me that there are really several different "levels" of quality planning. There is the quality system itself, which can be summarized into a flow diagram of sorts, or an overall quality plan. There could also be a design quality plan, which could outline the process of introducing new designs, again in a flow chart referencing the procedures or work instructions from the Quality System. There could again be another level of quality plan that would be part (or part family) specific i.e., an AIAG control plan.

How am I doing so far????

NOW....It also seems to me that all of these levels are, in fact, required (or strongly suggested) by the standard... Am I completely missing it??? I've been through lead auditor class and searched archives and read books and bought standards...but the more I read the more bewildered I seem to get!!!

Thanks in advance for the help!!!!

Kat K

 

[Marc]

Well, yes - you're on the right track. Companies have to plan for quality.

Many companies look to the design process for such planning - where the design process is where inspections and tests are determined and defined.

The requirement is (-- My thoughts --):

"4.2.3 Quality planning

The supplier shall define and document how the requirements for quality will be met. Quality planning shall be consistent with all other requirements of a supplier's quality system and shall be documented in a format to suit the supplier's method of operation. The supplier shall give consideration to the following activities, as appropriate, in meeting the specified requirements for products, projects or contracts:

a) the preparation of quality plans;

-- Quality Plans define required inspections and tests --

b) the identification and acquisition of any controls, processes, equipment (including inspection and test equipment), fixtures, resources and skills that may be needed to achieve the required quality;

-- Acquire equipment neccessary to perform defined inspections and tests --

c) ensuring the compatibility of the design, the production process, installation, servicing, inspection and test procedures and the applicable documentation;

-- Take a 'whole life cycle' approach --

d) the updating, as necessary, of quality control, inspection and testing techniques, including the development of new instrumentation;

-- Including responses to nonconformances (internal and external) --

e) the identification of any measurement requirement involving capability that exceeds the known state of the art, in sufficient time for the needed capability to be developed;

-- This is an old 'hanger on' that few companies will ever run into --

f) the identification of suitable verification at appropriate stages in the realization of product;

-- Typically defined in the control plan or 'quality plan' --

g) the clarification of standards of acceptability for all features and requirements, including those which contain a subjective element;

h) the identification and preparation of quality records (see 4.16).

-- You do inspections and test - determine what evidence you need --

NOTE 8 The quality plans referred to [see 4.2.3 a)] may be in the form of a reference to the appropriate documented procedures that form an integral part of the supplier's quality system."

Don't forget - a lot of what you are citing are often overlapping. The detail and depth of your planning is dependent upon a number of things including complecity of product and processes, intended use, size of you company, etc.

 

[Paul Vragel]

Maybe I'm missing your point of bewilderment, but here is another way to think of all this:

Elements such as process maps, FMEAs, control plans, operational instructions are mechanisms by which you achieve quality planning. They help you make sure that the parts of your system work together, you know what is important and what/how to check, etc.

If these are a part of your system, you can then point to these as achieving the quality planning objective, without creating a whole slew of separate "quality plan" documents.

------------------
Paul

 

[Marc]

Some thoughts:

From: ISO Standards Discussion
Date: Mon, 10 Jul 2000 09:29:12 -0500
Subject: Re: Quality Plans /Mower/Taormina/Vianna

From: "Vianna, Sidney"

Yes, quality planning is mandatory; however, the establishment of quality plans, which is a subset of quality planning might, or not, be required. For custom products, projects, programs, quality plans might be very useful. ISO 10005 provides guidance on quality plans, which are indeed documents. Unfortunately, one has to purchase the document, since it is not available for free download.

Also, please note that quality planning should be exercised in two ways: product quality planning and system quality planning.

Thanks and Best Regards

Sidney Vianna

--------------------------

From: Tom Taormina <Virtuiso>

Quality Planning is an activity, not a document. It is the actions that a company takes to ensure that adequate controls are planned into the work flow to ensure a defined level of quality. If you have only one product or service, your quality manual, operating procedures and minutes of management reviews can demonstrate quality planning. If you have multiple business operations, you need to build quality planning into each of them.

----------------------------

From: ISO Standards Discussion
Date: Mon, 10 Jul 2000 10:30:39 -0500
Subject: Re: Quality Plans /../Taormina/Phillips

From: Joseph D. Phillips

However, a Quality Plan can look like a QS-9000 Control Plan, or it could look like a nuclear ECN project control document.

I do them pretty often.

cheers,

Judojoe

-----------------------------

From: ISO Standards Discussion
Date: Mon, 10 Jul 2000 10:26:51 -0500
Subject: Re: Quality Plans /Mower/Pfrang

From: "Pfrang, Doug" Nicoletbiomedical

You might be asking the wrong question, because the quality plan format is unimportant. Therefore, the following response might not answer your question, but I hope it will help you solve your problem.

Note 8 of the ISO Standard allows quality plans to be in the form of a reference to the quality system documentation. Thus, a quality plan is merely a roadmap for how your firm intends to achieve its quality goals. One simple way to do this is to put a statement in your quality manual that outlines your quality system documentation. This could be a hardcopy list (e.g., a table of contents), or a list of the computer filename(s) of those procedures. It just needs to be something that identifies your procedures and records, or points to where they are kept; preferably (but not necessarily) showing that your documentation addresses all of the various ISO-900x requirements. If the master copies of all your procedures are stored in electronic form, it could be as simple as "Our quality plans consist of our controlled operating procedures (the master copies of which are located on the documentation department computer in folder c:\ISO9001\) and the records which are created according to those procedures."

Or, if you wanted to be more rigorous, you could identify the specific records that your firm considers to be its quality plans. These might include marketing specs, design plans, bills of materials, production schedules, test procedures, etc. However, I doubt such rigor is necessary.

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From: ISO Standards Discussion
Date: Mon, 10 Jul 2000 10:56:04 -0500
Subject: Re: Quality Plans /Mower/Kozenko

From: David M. Kozenko

Describing this topic using a more accurate "word painting" gives us the required action: Planning for Quality.

Documenting the required action gives us a document called a Quality Plan.

I'd advise against "canned" formats, and would strongly urge you to take a personal approach in order to develop and refine your ability to draw together Quality Plans (and do Quality Planning).

One activity that usually gets a lot of personal Quality Planning is your (annual or semi-annual) vacation. Think about how you've planned a few, and especially, what you learned when "planned quality" (also known as "fun" ;o) fell short of your selected metrics.

Now that you realize you've had years and years of Quality Planning experience (albeit maybe not on your present job), you'll approach the task with confidence, and that will show up in your results.

You'll also realize (during the documentation phase) that any Quality Plan is merely a sub-system, and can only function systematically with the other sub-systems your documented QMS. The classic (by now) "plan, do, check, review & improve" notion applies equally to all sub-systems.

Clear as mud?

David M. Kozenko

 

[Marc]

Remember - there is a significant distinction between a Quality Plan and Quality Planning.

 

[John C]

KatK,

The messages you are getting are diverse and not clarifying but adding to the confusion you got from courses and reading. I don’t take notice of anything but the wording of the standard. It makes it much easier. People talk about plans but we are concerned about 4.2.3.

When you read it carefully you’ll see that the actual requirement of 4.2.3 boils down to;

"Identify (all) requirements. Define and document how they will be met".

In the old days, quality was about inspection and test. Now it’s about meeting customer requirements and expectations. So the requirements we are concerned with are not just inspection and test but;

1) all customer requirements
2) your own policy and system requirements
3) ISO 9001 and other standards and certification requirements such as environmental, safety, health, etc.

Q. When are requirements identified and when are methods to ensure they are met, designed and documented?
A. Every time someone writes a procedure or a project plan.

Q. Where are requirements found?
A. 1) Customer requirements are in specs, drawings, contracts, minutes of meetings, etc. There are hundreds; dimensions, colours, delivery dates, process controls, etc, etc. All need to be addressed.
2) Your own requirements are in the policy statement, the workmanship standards, the method of working, the type of equipment, the training plans, etc.
3) The standards requirements are available but not necessarily in one area. You need to find out from safety engineers, maintenance officers, etc.

Your own documented system identifies and deals with the great majority of requirements. You don’t have to duplicate that or even do anything with it except to have a good indexing system so you can trace through how requirements are met, if you need to. A master list is already a requirement of ISO 9001 4.5.2. eg; If someone wants to know how delivery schedules are met, you need to be able to find the requirement by tracing through procedures concerned with contracts, purchase orders, procurement planning, production control, shipping planning and customer satisfaction to show how the requirement is met and reviewed.


There are three types of quality planning;

1) The individual requirements, as above - basically the documented system.
2) Big projects, eg; design, introducing a new assembly or a new product, developing a new documented system.
3) Maintenance and upgrading.

Projects need documented plans and reports, so you don’t need to do anything extra other than know where the plans and reports are filed and see that there is a documented requirement about identifying and meeting all relevant requirements.

Some people would say that existing audits and reviews are sufficient to meet the maintenance and upgrading of methods to identify and meet requirements. I believe that, at best, these are only maintenance activities and that, for improvement (a general and continuous requirement these days), we need a specific and more incisive method - a schedule of specific investigations by someone who knows what to look for - yourself I would say or a team put together and directed by you. This is a personal preference but, to my mind, a very important feature.

One short procedure - a couple of pages - will cover everything you need to arrange for taking care of 4.2.3. It should cover writing new procedures, project planning, and scheduled review of requirements as well as tracing through the system. Alternatively, there may already be procedures for developing procedures and managing projects so you could add to these and have one short procedure for scheduled requirements review.


KatK,
I hope that makes sense and helps to make it less confusing. Take what you wish from it. If there are any parts you disagree with, or can’t understand fully, then I’d be glad to follow it up here or by email.

Good luck and rgds, John C

 

[KatK]

WHEW! OK...first...THANKS FOR THE HELP! Really...I appreciate it. Now....drumroll...

This is the direction I'm going...feedback is welcome!

I am writing a Quality Planning Procedure that consists of multiple parts.

Part 1. I have taken one of the ideas from ISO 10005 and have a map of sorts of our process (from customer order to shipment) and am identifying where each of our procedure level documents apply in the process.

Part 2. Design planning is a type of quality planning that is done per our Design Planning Procedure

Part 3. Quality Planning is done and consists of a checklist of sorts (a quality plan) on which we review several things, most of them are the a-h of the 4.2.3 element. We also, however, consider our library of control plans and PFMEAs that are created for standard processes and products and consider if they are sufficient to meet the needs of the product. We evaluate each of our products for traceability and this is also documented on the quality plan (BONUS! I knew I'd get it in somewhere!!)
As needed, the QE may draw from the quality planning bag of tricks, which includes PFMEA, DFMEA, Control Plans, Characteristic Matrix, etc.

And...that's it. The more I think about it, the more I think it's really appropriate for OUR business. We are a company that generally makes product for market, not for a specific customer. We completely design our own stuff too...

I try NEVER to write a procedure merely to fulfill an element, but try to ALWAYS make it something that will be beneficial for us, and I think this will...but...I can always use advice!!!

Thanks again for all the input,

Kat K

 

[Marc]

Good distillation, John. Thanks!