Design and Development Audit
- Thread starter AlienraverX
- Start date
One possible explanation (and a sensible one, in my opinion) is that the schedule expects the internal auditor to pay attention to the inputs and outputs of the (product) design & development processes. Remember that you will be auditing a critical process that has very important interfaces with upstream and downstream processes.
Any process audit has to ensure that the inputs and outputs, as well as it's effectiveness are probed.
Good luck.
Any process audit has to ensure that the inputs and outputs, as well as it's effectiveness are probed.
Good luck.
A trick to this as well as any other audit is basically 2 fold -
1 - Are the basic requirements of the standard met (the planning) Yes or No and the evidence (procedures/instructions or whatever)
2 - Is/has the organization's planning (methodology) been met and/or achieved Yes or No and the evidence (procedures/instructions performed/implemented, records of performance/fulfillment and so on)
D&D (8.3) is probably the most complicated aspect of 9001 with the largest amount of basic documentation (and secondary as well) required of any of the major clause areas (dual digit). Your next most complicated area could be 8.5 with many of the same potential entanglements as 8.3.
A long time ago, in a standard far, far away, I had to create an 8 hour training course for the D&D process (7.3 under the previous 9001:2008) for a private client and it eventually became a public offering in our catalog because of its success after word of mouth recommendations. It was a tough subject to put to visualization and words especially for the design engineering folks that were targeted and the new 8.3 wouldn't be any easier.
Just make a good plan, use the standard and the supporting documentation as your checklist and press on.....Good luck
1 - Are the basic requirements of the standard met (the planning) Yes or No and the evidence (procedures/instructions or whatever)
2 - Is/has the organization's planning (methodology) been met and/or achieved Yes or No and the evidence (procedures/instructions performed/implemented, records of performance/fulfillment and so on)
D&D (8.3) is probably the most complicated aspect of 9001 with the largest amount of basic documentation (and secondary as well) required of any of the major clause areas (dual digit). Your next most complicated area could be 8.5 with many of the same potential entanglements as 8.3.
A long time ago, in a standard far, far away, I had to create an 8 hour training course for the D&D process (7.3 under the previous 9001:2008) for a private client and it eventually became a public offering in our catalog because of its success after word of mouth recommendations. It was a tough subject to put to visualization and words especially for the design engineering folks that were targeted and the new 8.3 wouldn't be any easier.
Just make a good plan, use the standard and the supporting documentation as your checklist and press on.....Good luck
Customer wants to order 500,000,000 gadgets with delivery date of next Tuesday. These are customer requirements related to the ORDER and have nothing to with the product design.
They then change the order to 2 with delivery date to this Friday. Once again, that is covered in 8.2 and has nothing to do with the design of the product.
They then change the order to 2 with delivery date to this Friday. Once again, that is covered in 8.2 and has nothing to do with the design of the product.
8.1, 8.2, 8.3, & 8.5 all tie together. You could argue that 8.4 does as well. Heck, you could argue that all portions of 8 tie together.
I have often speculated that ISO 9001 got the order wrong, at least for how most companies function. I would have put 8.2 first.
In 8.2 you gather requirements, from the customer and other pertinent sources. This includes reviewing them to ensure they are complete, correct, and you have the ability to perform.
In 8.3 you take requirements, usually from what you did in 8.2 but from other sources as well, and develop a product. There can be a lot of liability in design so ISO 9001 has safeguards to help minimize the risk, including the keeping of thorough records and reviewing progress frequently. Inadequate records is a big source for nonconformances in design.
In 8.1 you plan for production. There is usually some overlap with 8.3. Many feel that 8.1 mainly deals with the development of the traveler (or whatever you call it in your organization, router, work order, job ticket, etc.). Often the traveler doubles as a quality plan. This production planning sets things up for 8.5 so that production takes place under controlled conditions. 8.1 also includes some big picture elements like do we have a big enough facility, do we have enough people, do we have enough of the right equipment, etc.
8.5 deals mainly with production taking place under controlled conditions.
I don't see how you can audit D&D without auditing 8.3, which was not on your original list.
I hope this helps.
I have often speculated that ISO 9001 got the order wrong, at least for how most companies function. I would have put 8.2 first.
In 8.2 you gather requirements, from the customer and other pertinent sources. This includes reviewing them to ensure they are complete, correct, and you have the ability to perform.
In 8.3 you take requirements, usually from what you did in 8.2 but from other sources as well, and develop a product. There can be a lot of liability in design so ISO 9001 has safeguards to help minimize the risk, including the keeping of thorough records and reviewing progress frequently. Inadequate records is a big source for nonconformances in design.
In 8.1 you plan for production. There is usually some overlap with 8.3. Many feel that 8.1 mainly deals with the development of the traveler (or whatever you call it in your organization, router, work order, job ticket, etc.). Often the traveler doubles as a quality plan. This production planning sets things up for 8.5 so that production takes place under controlled conditions. 8.1 also includes some big picture elements like do we have a big enough facility, do we have enough people, do we have enough of the right equipment, etc.
8.5 deals mainly with production taking place under controlled conditions.
I don't see how you can audit D&D without auditing 8.3, which was not on your original list.
I hope this helps.
Sidney
Regarding this point:
that is covered in 8.2 and has nothing to do with the design of the…….
Sorry but I´m not agree with you, here.
Apart from getting from the customer the quantity, delivery date of the product, 8.2 also collects other data, e.g. regulations, standards to
comply in the design (asme, API, AWS codes), and all these information is taken as input in the D&D process.
In some way has a direct relationship wit D&D.
Hope this helps
Regarding this point:
that is covered in 8.2 and has nothing to do with the design of the…….
Sorry but I´m not agree with you, here.
Apart from getting from the customer the quantity, delivery date of the product, 8.2 also collects other data, e.g. regulations, standards to
comply in the design (asme, API, AWS codes), and all these information is taken as input in the D&D process.
In some way has a direct relationship wit D&D.
Hope this helps
Yet these are all parts of Operations. "Operations" includes "production", but is more than just production. That is, these (i.e., 8.x) are all part of the DO section in the ISO big-picture PDCA loop.
That said, I think of 8.1 as the high-level planning and articulation of how the entirety of Operations - including D&D, production, control of changes, post-sales activity, etc. - is going to function and how the process(es) will flow. So, with respect to D&D specifically: Has D&D been planned for? resources assigned? processes determined and documented? documented information determined and maintained? etc.
As for 8.5, as Sidney suggested, are D&D's outputs providing adequate and proper information for the requirements in 8.5.1? 8.5.6 Control of Changes would almost certainly involve coordination of interactions between D&D and Production, and so warrant looking at. As for the rest of 8.5 it seems that it depends on the authorities and responsibilities assignments your organization has determined for the various sections of 8 as to whether D&D has much impact on the rest of 8.5.
Still, it seems that ideally you should be provided clearer direction on why you were tasked with this combination of sections, or that you are allowed to make such inquiries. Otherwise, the expectations about your results seems unclear, and there is room for improvement in the planning of audits (9.2.2a).
That said, I think of 8.1 as the high-level planning and articulation of how the entirety of Operations - including D&D, production, control of changes, post-sales activity, etc. - is going to function and how the process(es) will flow. So, with respect to D&D specifically: Has D&D been planned for? resources assigned? processes determined and documented? documented information determined and maintained? etc.
As for 8.5, as Sidney suggested, are D&D's outputs providing adequate and proper information for the requirements in 8.5.1? 8.5.6 Control of Changes would almost certainly involve coordination of interactions between D&D and Production, and so warrant looking at. As for the rest of 8.5 it seems that it depends on the authorities and responsibilities assignments your organization has determined for the various sections of 8 as to whether D&D has much impact on the rest of 8.5.
Still, it seems that ideally you should be provided clearer direction on why you were tasked with this combination of sections, or that you are allowed to make such inquiries. Otherwise, the expectations about your results seems unclear, and there is room for improvement in the planning of audits (9.2.2a).
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