A home-grown Design Plan template that may be of interest to some folks.

I like your form, very nice, but it would fail my ISO registrar audit. We actually have to have a Target Date and an Actual or Completion Date on our form. The Target Date MUST be filled in all the way down to the last step upon initiation of the form. If something is Not Required, it must be noted as such.

:( we've been dinged on not filling in our form correctly so many times....it's frustrating. :frust:

Three of our forms are attached.

Interesting Comment Crusader,
I'm interested in the reasons why you think Watchwait's Design Plan would not pass your registrar? Is there a certain requirement you see not being met?

JR

Interesting Comment Crusader,
I'm interested in the reasons why you think Watchwait's Design Plan would not pass your registrar? Is there a certain requirement you see not being met?

JR

My post exactly describes why it would not pass the audit. One more ding and our cert will be held hostage.
edit: I don't see a requirement for target and actual dates for a design plan.

But my registrar keeps telling us that we must have a "plan" and "plans" outline design stages or steps, target and completion dates, responsible personnel or assigned personnel, etc. I'd like to see more design plans that other people use and have been approved for ISO 9001:2008.

My post exactly describes why it would not pass the audit. One more ding and our cert will be held hostage.

:confused: I understand the failure to complete the form as required would incur a ding from the registrar, but the only failing I see in Watchwait's plan is individual date spots to go with the Design Plan Approvals (signatures right?).

I am unaware of a requirement to define target dates in a development plan.

Help me see the failure here, because I feel am missing something. :frust:

Climber: My sense is that Crusader's "requirement" stems not from a specific regulatory base, but from her Notified Bodies "interpretation" of what is "typical/acceptable" for a Design Plan to meet 93/42/EEC Essential Requirments.

:confused: I understand the failure to complete the form as required would incur a ding from the registrar, but the only failing I see in Watchwait's plan is individual date spots to go with the Design Plan Approvals (signatures right?).

I am unaware of a requirement to define target dates in a development plan.

Help me see the failure here, because I feel am missing something. :frust:

The failure is........My registrar states that "design plans" must have target dates and completion dates. Target dates must be filled-in upon initiating the form and completion dates get filled-in as the plan evolves/progresses.

I am also confused because I don't see a requirement for what the registrar is stating. But I must comply to keep our ISO in good standing.

Crusader: I feel your pain! Consider this a case of losing the battle...but winning the war!;)

Climber: My sense is that Crusader's "requirement" stems not from a specific regulatory base, but from her Notified Bodies "interpretation" of what is "typical/acceptable" for a Design Plan to meet 93/42/EEC Essential Requirments.

In this case I wonder if the requirement was create by the associated procedure and the non-conformity is the failure to comply with the procedure.

Crusader, could be a point to ask your registrar to expand on the next time they are in.

The failure is........My registrar states that "design plans" must have target dates and completion dates. Target dates must be filled-in upon initiating the form and completion dates get filled-in as the plan evolves/progresses.

I am also confused because I don't see a requirement for what the registrar is stating. But I must comply to keep our ISO in good standing.

It sounds like you need to have a conversation with the auditor's manager. I've known many registrar auditors and this one doesn't seem to fit...

Something's askew here.

If a registrar is threatening to pull your cert over a single entry on a single form - albeit it's recurring - it's a problem. He needs to explain his basis for the nonconformity, and you CAN argue it / dispute it. If he's not willing to do that, escalate it.

Something definitely doesn't sound right, though.

I agree with Climber. Unless your own procedures locks you into doing more than the ISO 9001:2000/8 standard requires, your auditor is making up his own rules. This needs to be disputed with your registrar, and if the registrar still backs the auditor, dispute it with their accreditation body. Did your auditor tell you about how to file a dispute in the opening or closing meeting? He is supposed to. Look at your certification. If one of the seals is for ANAB, ANAB requires that. Normally you dispute it with the registration body first. If that fails, you can dispute it with ANAB.

Thanks for the tips everyone. My procedure did not lock us in to filling in the target date column on our form but it does now. I'd rather just comply and move on....and everyone is willing to fill-in the form as the registrar would like to see it. We'll try it and see how it goes....may change down the road and it may not.

The form itself states the requirement for the information. If the form has a place for information, it is implied to be required unless otherwise noted. Blanks should raise a red flag.

* ahem *

Forms are records of a procedure. The form documents the information and actions required by the procedure, and it should be defined within the procedure - or on the form- which information is required and which is supplementary or optional.

In the absence of a formal documented procedure, a form itself could be viewed as the procedure. Depends on your paradigm of what constitutes "procedure". The form asks for information that apparently must be gathered. So a blank would imply that the procedure wasn't followed (you didn't gather or provide the information that was needed for that step).

I think it's a bit precious of us to debate whether ISO requirements get into the weeds of how to handle blanks on a form. You defined your company's own requirement for the information simply by asking for it on the form and not describing it as optional.

Your auditor was correct. It was a valid Observation or Opportunity for Improvement or whatever designation they assigned. MHO....

And you were correct to ask for dates on your design plans. How can project management be effectively implemented without measures in place? And how can you measure without something to measure to?

ISO 9001 is a business management tool. It is not going to spell out every last detail of how to run your business. But if you have poor business practices then you are not aligned with the goals of ISO 9001 and each poor business practice is subject to Observations/Opportunites for Improvement.

:soap:

The form itself states the requirement for the information. If the form has a place for information, it is implied to be required unless otherwise noted. Blanks should raise a red flag.

You defined your company's own requirement for the information simply by asking for it on the form and not describing it as optional.

Your auditor was correct. It was a valid Observation or Opportunity for Improvement or whatever designation they assigned. MHO....


Just to clarify....
Our forms require the information on them because the registrar said we must have those fields there. We did not want those fields. My company did not define those blank fields, the registrar did. We had a simpler form and the registrar said it wasn't in compliance.

We're fine. It's all good.