Design Controls - Requirements - Specification - Trace Matrix

sreenu927

Quite Involved in Discussions
#1
Hi All..

This is regarding the design controls 21 CFR 820.30.

1. Is it necessary to have business requirements in the product requirements and specifications document?

2. We have given the priority levels to the specifications (design outputs) as high (1), medium(2) and low(3). But not defined anywhere in the trace matrix that priority 1 specs are essential specs for proper functioning of the device. Will it be a non conformance?

3. For non-essential design specs (outputs)(in this case, for moderate and low priorities), is it mandatory to have verification and/or validation activities performed to show in the trace matrix?

4. Where to keep the training records for a new product--with HR or in DHF??

Thanks,
Sreenu
 
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sagai

Quite Involved in Discussions
#2
Hi Shreenu,

1., I would call it "user need" what you have named as business requirements.
Yes it is necessary, more details:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm
It is necessity is simple, it is the requirement part for design validation.
I only guess, but potentially some part of it you already have among your requirements.
And this user needs also shall be traced down, and shall be traced back from your lowest level specification/requirement documentation.

2., I do not think all of the specification are part of the design output.
I do not understand this "priority" number. If the purpose of the trace matrix is to maintain the tracing/tracking of each individual requirement to its parent and to its children requirements in a corresponding upper and lower level specification document, than yes, all specification document shall be traceable.
Reason is simple, when you verify the requirement on any level you have to have a trace in order to identify root element, or the higher level requirement.

3., I think I have already shared my though about it :) Yes
I do not understand this naming "non essential", there are "functional", "performance", "interface", "safety" requirement classification as far as I consider.

4., DHF.
"The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part."
But HR can store the record itself if they like, and you reference properly from your DHF. (I only wonder how they ensure the record keeping period, anyway).

br
Sz.
 
J

JayJay

#3
Hi Shreenu,

Regarding your priority levels for your outputs, they should ink to some sort of risk analysis (FMEA, FTA, CCA, etc.) and at a minimum be based on the risk that those requirements / specifications pose to the physical device. When determining whether or not to include management specifications (procedures, work instructions, quality control practices), those should also be based on the risk that those specifications hold in terms of affecting the device, and ultimately the user of the device.

Either way, if you decide to include specifications in your DHF that you have not verified or validated, you would be well-advised to have something in writing stating why you didn't, and the "Why" part of that should be based on a documented risk analysis.

Hope that helps!

JayJay
 

sreenu927

Quite Involved in Discussions
#4
Hi Sagai and Jayjay,

Thanks for your reply.

as per 820.30(d) Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified.

For these ESSENTIAL outputs/specifications, the priority 1-HIGH was given. But no where in the trace matrix document, it was mentioned that HIGH (P1) = Essential design outputs.

Reg the business requirements, I mentioned, here is an example:
1.product shall cost < $X to manufacture

Do we need to include such requirements inside the design input/output and trace matrix documents?

If so, for such requirements/specifications, do we need to add verification and/or validation result?
I mean, for such non-essential (which are not affecting the proper working of the instrument) requirements, which are prioritized as moderate(P2) or Low (P3), is it mandatory to have verification and/or validation results inside the trace matrix.One solution, as JayJay mentioned is to hv proper justification for not having.
Any more thoughts?

Thanks,
Sreenu
 

sagai

Quite Involved in Discussions
#5
Hi,
I have never considered that "essential" wording with such importance, but it is rarely my view.
The example you gave for business requirement, for me, I saw such ones, but those were located in the product planning documentation, and you are right, it is not a user requirement, please ignore my previous post as regard identifying business requirement as part of the product related requirement.
You neither have to verify such business requirement, nor link into your requirement engineering specification structure. If you consider them as I suggested, than they subject to 820.30(b) only.
br
Sz.
 
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