Continuous Improvement - Procedure needed or not?

[mickeld - 2005]

Hey Everybody! I'm new to this site, and new to Quality Systems as well.

Brief background - I'm a co-op student who is working on implemeting a Quality Management System at my company. I have very little experience in this area, but I try hard. We are not going for and ISO registration currently. The system is needed to get onto a government qualification list. We manufacture office chairs.

Anyway, going thru my procedures I have done, I came across continuous improvement. It is referenced in the Management review - but do you need a written policy/procedure for it? During an audit, does the auditor look at this kind of thing?

Any help would be greatly appreciated.

 

[RoxaneB]

Hey Everybody! I'm new to this site, and new to Quality Systems as well.

First off, welcome to the Cove...and to the wild and wonderful world of Quality Systems, too!

Brief background - I'm a co-op student who is working on implemeting a Quality Management System at my company. I have very little experience in this area, but I try hard. We are not going for and ISO registration currently. The system is needed to get onto a government qualification list. We manufacture office chairs.

Anyway, going thru my procedures I have done, I came across continuous improvement. It is referenced in the Management review - but do you need a written policy/procedure for it? During an audit, does the auditor look at this kind of thing?

ISO 9001:2000 has 6 required procedures:

• Control of documents
• Control of records
• Internal audits
• Control of nonconforming product
• Corrective action
• Preventive action

There is, of course, the caveat of "...documents needed by the organization to ensure the effective planning, operatio and control of its processes..." (4.2.1 d).

8.5.1 Continual improvement states "...improve the effectiveness...through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review."

No stated requirement for a procedure specifically for Continual Improvement, but the Quality Policy needs to be documented, the Quality Objectives need to be documented, audit results are to be recorded, the data being analyzed is most likely recorded somewhere, corrective and preventive actions require procedure(s) and records, and management review requires records....so there is still documentation that supports your quest for Continual Improvement.

My Organization addressed CI thusly...in our Quality Manual we state the tools that help us in the ongoing journey of Continual Improvement. It includes the items listed in Section 8.5.1 of ISO 9001:2000, but our own Management System tools such as Annual Action Plans, Key Indicators, and so on.

 

[The Taz!]

ISO 9001:2000 has 6 required procedures:

• Control of documents
• Control of records
• Internal audits
• Control of nonconforming product
• Corrective action
• Preventive action

To add to my perfect and agile friends words above. . .

For TS there are 7. . . 6.2.2.2 Training. And if you read the requirements carefully, you will see that there are a couple of those that must be documented "IN" a prodedure, and those where a DOCUMENTED Procedure is required.

The important thing is to address the required processes in documented procedures.

The standard will state the reqirements 3 ways,

1) "The organization shall have a process to. . ."

2) "The organization shall have a documented procedure for. . . " , and

3) ". . . in a documented procedure"

Continual Improvement is a process. . . and must be defined IN a documented procedure (8.2.2 last paragraph under Internal Audit - ISO Requirement). The process could be defined as a part of management responsibility or committment. . . or "Audit Activities" for example. . . or even Corrective or Preventive Actions. It depends on how your QMS is setup and what your business model is.

JMHO. . .

 

[mickeld - 2005]

Thanks for the welcome!

I'll take your info, and any other if someone else replies to this, and try to get everything to work.

Just a couple Q's - you say documented policy. Is one in the QA Manual Count? And where would I document Quality Objectives? A "procedure" or do they tie in with the policy?

 

[Wes Bucey]

First off, welcome to the Cove...and to the wild and wonderful world of Quality Systems, too!



ISO 9001:2000 has 6 required procedures:

• Control of documents
• Control of records
• Internal audits
• Control of nonconforming product
• Corrective action
• Preventive action

There is, of course, the caveat of "...documents needed by the organization to ensure the effective planning, operatio and control of its processes..." (4.2.1 d).

8.5.1 Continual improvement states "...improve the effectiveness...through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review."

No stated requirement for a procedure specifically for Continual Improvement, but the Quality Policy needs to be documented, the Quality Objectives need to be documented, audit results are to be recorded, the data being analyzed is most likely recorded somewhere, corrective and preventive actions require procedure(s) and records, and management review requires records....so there is still documentation that supports your quest for Continual Improvement.

My Organization addressed CI thusly...in our Quality Manual we state the tools that help us in the ongoing journey of Continual Improvement. It includes the items listed in Section 8.5.1 of ISO 9001:2000, but our own Management System tools such as Annual Action Plans, Key Indicators, and so on.

Let me add there is a difference in "perception" between "continuous" and "continual" improvement. Check this thread for an excellent discussion of the distinction http://elsmar.com/Forums/showpost.php?p=79285&postcount=8

 

[RoxaneB]

Just a couple Q's - you say documented policy. Is one in the QA Manual Count? And where would I document Quality Objectives? A "procedure" or do they tie in with the policy?

The Quality Policy is that document which serves as an "executive summary" of your Organizatin's Quality Management System. It says what you do, how you will commit to comply with requriments and continually improve the QMS, references the Quality Objetives, is communicated and understood throughout and is reviewed.

Some organizations choose to put it in their Quality Manual...some organizations select other locations.

Where you document QualOb's is up to you...what works best for your organization? Are they going to change frequently? If so, keep them separate from the Policy and Manual.

 

[mickeld - 2005]

Where you document QualOb's is up to you...what works best for your organization? Are they going to change frequently? If so, keep them separate from the Policy and Manual.

We have a Policy in the Manual already, and it fits there.
I actually do have some quality objectives - they're just called principles here. They are documented separately from the Manual already, so changes to them will be easily made.

Thanks for the help from all of you!

 

[Swagg - 2009]

At my company, we choose to write a CI policy, we are a regulated industry(FDA) and it appears to be the trend,document,document,document.

 

[WALLACE]

Are you using the ISO models

mickeld,
Welcome to the Cove.
Are you using the ISO 9004 guidelines and the ISO 9001 standard as your current benchmark for developing your QMS?
If you are developing a fledgling QMS, your in a great position to build a sound quality management foundation. You've came to the right place for all the advice you'll need.
Wallace.

 

[mickeld - 2005]

mickeld,
Welcome to the Cove.
Are you using the ISO 9004 guidelines and the ISO 9001 standard as your current benchmark for developing your QMS?
If you are developing a fledgling QMS, your in a great position to build a sound quality management foundation. You've came to the right place for all the advice you'll need.
Wallace.

Thanks for the welcome Wallace.

I am using the ISO 9001 standards and the 9004 guidelines - as far as I can. Pretty much we're just doing the minimums that a government agency requires of us. I don't know if my company will one day go for ISO registration, but it is still good to get a well done QMS in place.