Question on Clause 7 Design Related Exclusions

[wilsonmm]

Greetings all. My question is what is permissible as a reason for an exclusion in ISO 9001:2000, clause 7. I don’t know if it really makes any a difference, but our company is going for ISO compliance, and not certification.

We have an engineering and IT section where we design products and write software, but software is typically a single program for a single user, and products are usually a one of a kind, or no more than five or six of a single item. Also, we have just ONE customer – the government.

We estimate that implementing clause 7.3 would add a minimum of 20% to the cost of every design task we receive, and I doubt the customer is interested in paying an additional 20% on all of our work. So, my question is can we exclude all, or parts of 7.3 and still pass a compliance audit if our customer waives those requirements in whole or in part? In other words, is customer waiver a valid or acceptable exclusion?

 

[ScottK]

Re: Question on Clause 7 Exclusions

Greetings all. My question is what is permissible as a reason for an exclusion in ISO 9001:2000, clause 7. I don’t know if it really makes any a difference, but our company is going for ISO compliance, and not certification.

We have an engineering and IT section where we design products and write software, but software is typically a single program for a single user, and products are usually a one of a kind, or no more than five or six of a single item. Also, we have just ONE customer – the government.

We estimate that implementing clause 7.3 would add a minimum of 20% to the cost of every design task we receive, and I doubt the customer is interested in paying an additional 20% on all of our work. So, my question is can we exclude all, or parts of 7.3 and still pass a compliance audit if our customer waives those requirements in whole or in part? In other words, is customer waiver a valid or acceptable exclusion?

well - since you're not going for registration you really don't need to justify your reasons for skipping that part.

but judging from your explanation if you were to go for registration you would need to include 7.3 because you do "design product".

My big question is how is this adding 20% to the cost?
You probably already have the processes in place and just need to document them.

 

[chergh - 2008]

Re: Question on Clause 7 Exclusions

If your going for compliance and not certification you will not be getting 3rd party audits so the only audits you will have are internal audits and customer audits.

If your customer agrees to waive those sections then your not going to have any issues.

I would be interested in where you pulled the 20% increase in cost figure from though.

 

[ddunn]

I would also like to know how section 7.3 is going to add 20% cost.

I've always found that proper implementation of a design and development process reduces cost.

Please note the "proper implementation".

 

[Sidney Vianna]

I've always found that proper implementation of a design and development process reduces cost.

Please note the "proper implementation".

Well said. But the OP's organization must be heralded as the only organization in the World that has never had "quality problems" and customer dissatisfaction due to poorly designed products and flawed software. At least, that is what we are led to believe since they perceive controlling the design and software development processes as unnecessary costs.

But in answer to the OP, when it comes to "compliance", you can deem anything as non-applicable such as design and development, management responsibility (that too just adds costs), etc...Whatever makes you and your customers happy...

 

[fuzzy]

Greetings all. My question is what is permissible as a reason for an exclusion in ISO 9001:2000, clause 7. I don’t know if it really makes any a difference, but our company is going for ISO compliance, and not certification.

We have an engineering and IT section where we design products and write software, but software is typically a single program for a single user, and products are usually a one of a kind, or no more than five or six of a single item. Also, we have just ONE customer – the government.

We estimate that implementing clause 7.3 would add a minimum of 20% to the cost of every design task we receive, and I doubt the customer is interested in paying an additional 20% on all of our work. So, my question is can we exclude all, or parts of 7.3 and still pass a compliance audit if our customer waives those requirements in whole or in part? In other words, is customer waiver a valid or acceptable exclusion?

As all before me have said, you can exclude anything in Section 7 and claim "ISO compliant". You won't be audited with certification on the line against that claim.

But I have heard that claim before and worse (We'll go out of business if we have to do design reviews! ) when I was the consultant to my current company. Eventually after all the hand-wringing, we developed a system where design review and all the other 7.3 requirements take many different forms, all contingent on the nature of the product. For a $50 widget it may be an engineers sign-off; for a $1,000,000 project it may require a sit down meeting with a dozen people and the customer. We made the system fit the requirements and our business (which includes DOD work). You have the same opportunity...don't wimp out here if you truely want to improve your business by being ISO compliant.

 

[wilsonmm]

Thanks for all the responses. We’re going to include it as planned.

The 20% increase in cost was a figure Engineering gave me as their estimate. I would guess it’s all represented by time since every hour of our day is chargeable to specific cost codes for different tasks. We already do most of what 7.3 requires, but it’s all informal. Bringing it into ISO would required us to formally document all the informal steps. Also, informal reviews would have to be more formal, include others from other departments, and documented also with time charged accordingly. Also, we have new management software that runs virtually every facet of the organization that’s new, confusing, and takes a lot of time to navigate through all the fields to find where you need to be. Another time consumer.

But probably the biggest factor is that our engineers have “done their own thing” forever, so this change isn’t being well received. Anything they can do to throw a wrench into the machine is a high priority.

 

[AndyN]

Another number that might be worth factoring in is the cost of processing non-customer required changes, after product release.

In a previous life, the cost of processing a design change (the customer didn't request these) was $1,000 and up to 25% of our Engineering resources were working on them at any one time. Since most new (read recently qualified/hired) engineers were put onto these tasks when they joined, we had high(er) turn over and recruiting costs as a result - they would stay for about a year and leave frustrated since they didn't work on new designs..........

Of course, there are many other related costs in addition.

Kinda makes a 20% increase in 'proper' design costs look small..............

Andy

 

[Jim Wynne]

Another number that might be worth factoring in is the cost of processing non-customer required changes, after product release.

Yes--the design cleanup phase is a giant money pit in most companies, and the ironic thing is that there never seems to be a process in place to fix the problem. As you point out, there are often resources dedicated to the task on a permanent basis, which creates a self-fulfilling prophecy. Sadly, design engineers are almost never held to the same expectations as production when it comes to the quality of output.

 

[Sidney Vianna]

Yes--the design cleanup phase is a giant money pit in most companies, and the ironic thing is that there never seems to be a process in place to fix the problem. As you point out, there are often resources dedicated to the task on a permanent basis, which creates a self-fulfilling prophecy. Sadly, design engineers are almost never held to the same expectations as production when it comes to the quality of output.

Right you are. This is definitely a major dysfunction in the Corporate World. I made some similar comments in this post inappropriately placed at that thread.