We were recently assessed by our registrar and one of our action items is this:
Even though the design activities and their responsibilities have been clearly defined, there is no evidence of a schedule which identifies estimated start dates and actual finish dates for the respective design activities in order to demonstrate the management and delivery of the outputs as the development progresses.

The ISO 9001 standard does not actually state in black and white text that a schedule with actual start and finish dates is required. Is this one of those implied shalls?

Opinions?

We were recently assessed by our registrar and one of our action items is this:
Even though the design activities and their responsibilities have been clearly defined, there is no evidence of a schedule which identifies estimated start dates and actual finish dates for the respective design activities in order to demonstrate the management and delivery of the outputs as the development progresses.

The ISO 9001 standard does not actually state in black and white text that a schedule with actual start and finish dates is required. Is this one of those implied shalls?

Opinions?

Hello Crusader,

No not really, the auditor is probably referring to this:

(From ISO 9001:2000)

7.3.1 Design and development planning
The organization shall plan and control the design and development of product.
During the design and development planning, the organization shall determine
a) the design and development stages,
b) the review, verification and validation that are appropriate to each design and development stage, and
c) the responsibilities and authorities for design and development.
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.
Planning output shall be updated, as appropriate, as the design and development progresses.

A plan would include start and finish dates to monitor progress.

Would this clarify?

Stijloor.

Nope it does not clarify. We do all of that. There is evidence of all of it but no specific dates. Everything is very clear - all stages, etc.

The reality is that the whole process for this product line can take place in 1 hour or less. Why do we need a schedule with dates?

Since you indicated Clause 7.3 of the standard; should we assume that this is a finding is indicating that your organization is not conforming to most of the requirements of the standard in this area. If not could you please specify which sub-clause this finding was written against then response to your question could be more specific.

Since you indicated Clause 7.3 of the standard; should we assume that this is a finding is indicating that your organization is not conforming to most of the requirements of the standard in this area. If not could you please specify which sub-clause this finding was written against then response to your question could be more specific.

No subclause was given by the registrar. Only "7.3" when we asked him.
We comply completely with the exception of this phantom schedule requirement.

Nope it does not clarify. We do all of that. There is evidence of all of it but no specific dates. Everything is very clear - all stages, etc.

The reality is that the whole process for this product line can take place in 1 hour or less. Why do we need a schedule with dates?

Are most of your designs completed within 1 hour or less?

Stijloor.

Are most of your designs completed within 1 hour or less?

Stijloor.

Yeah. Basically, we use extremely similar designs from previous products.

Yeah. Basically, we use extremely similar designs from previous products.

Then it would make no sense to establish a time line for a design process that is accomplished in that short amount of time.

However, the design process can be divided into:

Completely new designs
Modifications of an existing design
Minor modifications
Do all these apply to you?
Was the auditor referring to completely new designs?

Having said this, why was your concern not raised and addressed during the closing meeting?

Stijloor.

It sound like your auditor is saying that your process does not define a start and completion date and that as the design is moving through the process of development to meet the completion date there is no objective evidence that each step in the process has been completed before the next one starts which is usually indicated by a date.

In the simplest form a D & D process of product development is just like a work order to manufacture product (in this case a design) with specific operations which must be completed before the next operation can begin. Again this usually involves identification of who completed the operation and when it occurred. In a one hour or one day process this could be through the use of a time line.

We have what you describe in detail (4 levels of design projects and each requiring specific documentation) and we did raise the question and lost.
There seems to be some phantom requirement in ISO 9001 where a "timeline" or "schedule" is required regardless of the time and efforts required for a design project.

We'll create something to satisfy - may just end up putting the dates on design documentation or printing out the schedule of design projects to be completed from weekly meetings.

Crusader,

How do you track the design process progress now? I've seen project planning software used for that purpose. Let's leave the ISO 9001:2000 standard alone for now; who in your organization is interested in seeing that the product design is completed on time? What are your internal requirements? How would a design engineer respond when asked about the progress of the design? Take it from there...that may help.

Stijloor.

Before you do jump through the hoops on this I would call your registrar and ask them what their audit requirements are for this section of the standard. Most registrars set guidance for their auditors to following when auditing the standard.

Also ISO/TC 176 has an interpretation service at http://www.tc176.org/Interpre.asp

Thank you Jeff!

Here (http://www.tc176.org/pdf/rfi031_final.pdf) is an interpretation.

Stijloor.

Crusader,

How do you track the design process progress now? I've seen project planning software used for that purpose. Let's leave the ISO 9001:2000 standard alone for now; who in your organization is interested in seeing that the product design is completed on time? What are your internal requirements? How would a design engineer respond when asked about the progress of the design? Take it from there...that may help.

Stijloor.

They have a project "To do/In process/Wish" list that they go over periodically with Management.
Management is interested in seeing the status of this list.
Internal requirements? - we have estimated time to complete but projects consistently get bumped by Management! :mg:
Design engineers dance pretty good when asked those questions. :lol:

Internal requirements? - we have estimated time to complete but projects consistently get bumped by Management! :mg:
Design engineers dance pretty good when asked those questions. :lol:


Could it be that this is what the auditor observed and was referring to in the audit report?
Opportunity knocks...and we can always get better. ;)

Stijloor.

Nope it does not clarify. We do all of that. There is evidence of all of it but no specific dates. Everything is very clear - all stages, etc.

The reality is that the whole process for this product line can take place in 1 hour or less. Why do we need a schedule with dates?


A Design Plan would typically include dates, but if it can be completed in 1 hour, thta obviously would not add value. However, what Design Process can " complete the whole process in 1 hour?"

We have what you describe in detail (4 levels of design projects and each requiring specific documentation) and we did raise the question and lost.
There seems to be some phantom requirement in ISO 9001 where a "timeline" or "schedule" is required regardless of the time and efforts required for a design project.

We'll create something to satisfy - may just end up putting the dates on design documentation or printing out the schedule of design projects to be completed from weekly meetings.


There are no "phantom requirements" in ISO. There are frequent misinterpretations and misunderstandings, however. There is something not clear in this conversation, so the right thing to do is ask the auditor to help explain which requirement specifically is being violated. I agree dates are typical in a Design Plan, but it has to be considered in view of your particular situation. Please refer to the question in my other reply.

A Design Plan would typically include dates, but if it can be completed in 1 hour, that obviously would not add value. However, what Design Process can "complete the whole process in 1 hour?"

Helmut,

I worked with a company that manufactured specialty chemicals for the textile industry (dye processes). They were able to receive customer requirements for a special application, designed the mixing formula, verified the design, produced a test batch, validated the chemical product, and all that within or around one hour. I found it amazing, but that's what made them so competitive.

Stijloor.

I'd suggest that doing a design in a few hours is not design - it's a design change or modification, therefore only the Design Change requirement should be applicable.

If you are taking basically similar products (Crusader, this is based on my experience of your product application), then that isn't really 'design'. Indeed, the design was orginally performed many years ago, in some instances. Often you will do new/innovative design, new applications etc., however, making a product taller, wider, lower, different material etc. doesn't have to be treated throught the same fundamentl (new) design process.

Your design documentation (procedure) may not be appropriate for this situation and could be forcing you down this route. I'd suggest that your management really look closely at this situation, it may be helpful. Sure, they will want to call it 'design' but if it is really a change, you are probably better off to call it that........

I just wanted to say Thanks to everyone for your input. I haven't been ignoring this thread, just been real busy with the annual SEMA show coming up. Anyhow, I am going to consider all your input and re-think the process to try and help our R&D guys so that they are not burdened with non-value added paperwork. There are some very good suggestions here.

:bigwave:
Thanks!

There are no "phantom requirements" in ISO. There are frequent misinterpretations and misunderstandings, however. There is something not clear in this conversation, so the right thing to do is ask the auditor to help explain which requirement specifically is being violated. I agree dates are typical in a Design Plan, but it has to be considered in view of your particular situation. Please refer to the question in my other reply.

You know, we did ask and all he said was "7.3" and that a schedule with dates is implied. :confused: So not fair! Anyhow, we'll comply with a simple schedule from the project tracking list. The work instructions / forms already complete the remainder of the design requirements.

A Design Plan would typically include dates, but if it can be completed in 1 hour, thta obviously would not add value. However, what Design Process can " complete the whole process in 1 hour?"

A completely new application, from a similar application, that only requires a fit check for length or a new end-fitting, a different bend, new material etc. It's that simple. It is not just a design change for an existing application - it is in fact a new design for a new application. (-just answering your question)