- Product History File (PHF)12
This file contains the history of how the product was developed and what, and why decisions were made. For example, it includes all requirements, risk assessments, lists of standards, tests performed, compliance certificates, manuals, designs, tests, analyses, reviews, meeting notes and decision information generated for the product. The PHF is preserved for product traceability, portability, maintainability, legal, intellectual property and corporate value reasons. The PHF remains with the responsible 'owner' of the product.
Historical data that is neither implemented nor pertinent to the eventual design, such as test ID concepts, investigatory software and hardware, sketches, etc. need not be included in the PHF. Remember that this file retains the information only pertinent to the implemented design and implementation methodology.
Maintaining these files can reduce by 25% to 30% the time engineers usually spend looking for and managing documentation.13 Usually they are maintained on a web-accessible server (with appropriate password protection) so that dispersed team members have access.
- Product Master Record (PMR)14
This file contains everything the manufacturer needs to know in order to procure components, tool-up for production, assemble, test, validate [compliance], ship, install, test, calibrate, service and support the product. It will contain some of the same information as the PHF such as: standards and compliance certificates [Declaration of Conformity, etc.], manuals, and those necessary for marketing purposes. This file will remain with the responsible manufacturer and service groups. It needs to be complete enough to enable qualification of alternate manufacturers - if need be.
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©1999, 2005, Richard M. (Dick) Haney
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