|
Following on from my previous message in support of standardization, I cannot understand why each phase and sub-phase of the lifecycle deserves its own data/documentation format. The way I see it, each and every ‘regulated technical element’ needs to be explicitly (i) identified, (ii) specified and (iii) supported by a test procedure for the phase in question. End of story - almost. While the content and timing of each of the three aspects can certainly vary from item to item (depending on class, risk etc.), there is no justification for the degree of ‘format variability’ that exists across phases, disciplines & projects. I am also arguing for absolute connectivity between successive stages, with specification being treated as a logical extension of itemization, and testing a further extension of specification. This is a classic example of continuous processing, in my view. This message invites discussion and feedback in regard to ‘frugality of formats’ as a constituent of Self-Evident Engineering (SEE).
|
|
Current-state compliance relies on 100% document-by-document approval, with little or no provision for modular or family-based acceptance. The desired-state alternative is summarized here courtesy of Genentech’s Ron Branning, a major advocate of standardization as a prerequisite of Self-Evident Engineering (SEE).
“Developing and applying agreed industry standards for specification and validation would:
- Yield reliable, self-validating outputs at each stage of the development process
- Eliminate redundancy in testing and documentation
- Eliminate ambiguity in specifications
- Eliminate gaps and overlaps in departmental roles and responsibilities
- Allow regulatory/quality to audit the standards rather than individual tests
- Save companies time and resources
- Adapt readily to innovation.”
I look forward to your feedback re the above, particularly in regard to the opportunities/implications associated with item 5.
|
