Should every Management System include Design?

[Pristinapete]

Andy,

Thanks, I was thinking more in terms of the expert O&M contractor offering their predictive maintenance services to reduce the cost of the preventive maintenance specified in the contract.

Such service design and advice though is often given away for free.

John

A valid point John, but I would add that the majority of O&M contractors should be (if they are any way worth their salt) using an O&M software package such as the Mexx system. The customer is paying for us to carry out preventitive maintenance. As a company wanting this provision I would be looking for a price. As a company offering such a service I would be providing a price. The software package will determine frequencies (after all data is input) so the only cost reductions that can be made are in the cost of parts and labour. Not really a design issue as the cost of maintenance is not specified in the contract but is determined in the bid offered. Replacing Part A at X price for Part A at Y price does not really constitute a change in design (in my view).

And offering the customer an improved service for the same price is not (again in my opinion) a change to design but more liely to be a change to the product/service provision processes,

Regards,

Pete

 

[John Broomfield]

All,

I agree that for certification purposes the requirements of clause 1.2 tend to prevail.

After ascertaining the importance of the service part of a company's products you may find that service is the main thing that concerns customers. Indeed, service quality may be a quality objective.

Accordingly, for the management system to be adequate it must also assure service quality and enable continual improvement of service quality.

As such the system may include service specifications. The quality manual may also have to describe two scopes:

• Scope of the system (as it is)
• Scope of the system for the certificate (with no mention of service)

But surely the system should be for more than just certification?

I suppose that scope B cannot be the same as A because of clause 1.2. But in doing so are we are in danger of ignoring clause 5.6.1 that requires the system to be adequate?

John

 

[Mikelangelo]

But surely the system should be for more than just certification?



John

John, I totally agree

(Instead of an ? there should be an ! at the end of the phrase)

Mike

 

[dv8shane]

My point is simply that the system can (please ignore shouting) include design but that doesn't mean that it should necessarily.

I agree with you Boris, but would also point out there are cases such as mine where design and development are not applicable. For example as a calibration laboratory my company uses procedures that are developed by the military and we only have to validate them prior to use. I do not fall under the clause. I asked my auditor what if I am making my own test reports based on others tests with slightly different test points and he said that forms do not fall under design in this case too.

Shane

 

[DrM2u]

I agree with you Boris, but would also point out there are cases such as mine where design and development are not applicable. For example as a calibration laboratory my company uses procedures that are developed by the military and we only have to validate them prior to use. I do not fall under the clause. I asked my auditor what if I am making my own test reports based on others tests with slightly different test points and he said that forms do not fall under design in this case too.

Shane

Yes, the design of the forms probably does not fall under the Design. How about the design of the business? Did this calibration laboratory pop up overnight like a mushroom or did someone Design (aka Plan) the business?!? Did someone look ahead of time at what what it takes to provide the calibration Services (aka Product in ISO 9001 lingo)? What standards are applicable, what equipment, what personnel, what methods, what controls, what materials, who are the customers, etc ... IMHO a good Design with a few sprinkles of Luck make for a successful business. Ponder my questions then answer this one: is Design applicable to a calibration laboratory or not?

 

[dv8shane]

Yes, the design of the forms probably does not fall under the Design. How about the design of the business? Did this calibration laboratory pop up overnight like a mushroom or did someone Design (aka Plan) the business?!? Did someone look ahead of time at what what it takes to provide the calibration Services (aka Product in ISO 9001 lingo)? What standards are applicable, what equipment, what personnel, what methods, what controls, what materials, who are the customers, etc ... IMHO a good Design with a few sprinkles of Luck make for a successful business. Ponder my questions then answer this one: is Design applicable to a calibration laboratory or not?

Not as far as I was able to prove. My procedure for creating calibration instructions included keeping the first completed test data report as the equivalent of an FAI. Every instruction is validated including diagrams created internally as well as documents of external origin etc. After debating with the AS9100 auditor and asking several other lab owners who operate under 9001 all of whom claimed the exclusion. I came to the conclusion I can not design a service and the audit cost me less.

As to the design of the business I authored the 17025 and AS9100 combined manuals procedures uncertainty budgets, business plan acquired the assets etc to start in 3 months in my spare time. Prior to this I had never written a quality document, only read them.

 

[JaneB]

How about the design of the business? Did this calibration laboratory pop up overnight like a mushroom or did someone Design (aka Plan) the business?!? Did someone look ahead of time at what what it takes to provide the calibration Services (aka Product in ISO 9001 lingo)? What standards are applicable, what equipment, what personnel, what methods, what controls, what materials, who are the customers, etc ... IMHO a good Design with a few sprinkles of Luck make for a successful business.

I think you're beginning to draw a slightly long bow here, by wanting to apply 7.3 to the overall 'design' of a business. Yes, there are common elements, but design (and the specific requirements of 7.3) is not an exact synonym for business planning.

 

[John Broomfield]

John, I totally agree

(Instead of an ? there should be an ! at the end of the phrase)

Mike

Mike,

Thanks, I used the question mark because many Covers seem focused only on implementing ISO 9001 for certification purposes. Most, when reminded, will acknowledge side benefits. I was even told my suggestion was wrong because a third party auditor would not accept it!

Here we are talking about developing the system that runs the organization so it can be used to improve the business beyond conformity to ISO 9001.

If we are careful when defining our products (and the selection criteria used by our customers) we will inevitably see how significant service is.

After 15 pages of debate I still recommend using service specifications to assure and continually improve the quality of your service even if the goods you deliver are designed by your customers.

John

 

[JaneB]

... many Covers seem focused only on implementing ISO 9001 for certification purposes. Most, when reminded, will acknowledge side benefits.

Think it depends upon what their immediate objective is, John. If someone is still working their way toward certification, then it's reasonable for that to loom pretty large in their mind right now.

But your comment about side benefits is rather disparaging to the majority and seems a little unfair. I see plenty of evidence of people in the Cove, both regulars and others, with a focus on the improvements to be gained and the benefits of having a sound quality management system beyond mere certification.

 

[somashekar]

Mike,

Thanks, I used the question mark because many Covers seem focused only on implementing ISO 9001 for certification purposes. Most, when reminded, will acknowledge side benefits. I was even told my suggestion was wrong because a third party auditor would not accept it!

Here we are talking about developing the system that runs the organization so it can be used to improve the business beyond conformity to ISO 9001.

If we are careful when defining our products (and the selection criteria used by our customers) we will inevitably see how significant service is.

After 15 pages of debate I still recommend using service specifications to assure and continually improve the quality of your service even if the goods you deliver are designed by your customers.

John

Hi John.
Compliments on your quality thinking and stressing service beyond meeting customer requirement. Your finer elements on enhancing customer delight through service beyond product delivery, quality and performance is much appreciated.
Still in any big way you see, nothing seems to be beyond what the ISO 9001 generically states. Here we have people who come from all levels of industries and experience and many times seek simple and effective steps that they as an organization can implement towards conformity to ISO 9001. We would always prefer to give what would best suit them and let them take steps in a way that is fitting to their organization's growth and maturity.
Many a times it so happens that what we discuss and post as perhaps the superior way of QMS establishment, will be understood as requirements and thus a clash of ideal Vs actual will get them to feel distanced from the QMS implementation, and this would result in the ISO 9001 concepts to be repelled or even hated by them. This is certainly not our intention.
There is no one way of QMS implementation. I still always believe that no one wants to do a bad job, same time no one can be said as performing the BEST.