Actually, you do not have to release a zero defect product, so you can decide that you change the design later in order to comply with your product related requirement, so it is not mandatory to correct every deviation found during the design verification/validation.
But the remaining defect should not effect patient safety and shall be rationalized why are they can be solved later. Actually the remaining defects shall be in line with the quality goals defined in a planning stage very earlier. (I am in a software MD area)
The exact implementation of the change depends on the documentation hierarchy used in your requirement engineering.
In case you have:
1., User Requirement
2., System Requirement
3., Detailed Design Reguirements,
than
I. during to course of the correction of the deviation found in validation, than:
a., someone did not completed the required work as defined in the requriement -> 3., shall be reworked
b., the 2., was not properly defined based on the corresponding 1., -> 2., 3., shall be reworked plus the impact of this change shall be evaluated, if any safety related function interfered, the correction can be even more overkill.
II. during to course of the correction of the deviation found in verification, than:
a., someone did not completed the required work as defined in the requriement -> 3., shall be reworked
b., the 3., was not properly defined based on the corresponding 2., -> 3., shall be reworked plus the impact of this change shall be evaluated, if any safety related function interfered, the correction can be exhausting.
br
Sz.
But the remaining defect should not effect patient safety and shall be rationalized why are they can be solved later. Actually the remaining defects shall be in line with the quality goals defined in a planning stage very earlier. (I am in a software MD area)
The exact implementation of the change depends on the documentation hierarchy used in your requirement engineering.
In case you have:
1., User Requirement
2., System Requirement
3., Detailed Design Reguirements,
than
I. during to course of the correction of the deviation found in validation, than:
a., someone did not completed the required work as defined in the requriement -> 3., shall be reworked
b., the 2., was not properly defined based on the corresponding 1., -> 2., 3., shall be reworked plus the impact of this change shall be evaluated, if any safety related function interfered, the correction can be even more overkill.
II. during to course of the correction of the deviation found in verification, than:
a., someone did not completed the required work as defined in the requriement -> 3., shall be reworked
b., the 3., was not properly defined based on the corresponding 2., -> 3., shall be reworked plus the impact of this change shall be evaluated, if any safety related function interfered, the correction can be exhausting.
br
Sz.
