Functional and Physical Configuration Audits
Functional Configuration Audit
Configuration Audit (FCA) verifies that the configuration item (in this
case, the complex electronics design and programmed device) meets all
the functional requirements, including performance. The FCA represents
a review of the item's performance, to ensure it not only meets the
specification but that there are no unintended functional
characteristics. FCAs may be conducted early in the prototype stage, to
ensure that the design will meet the requirements. A final FCA is
conducted after testing is complete and concrete data is available to
show that the device meets its requirements. The FCA must be conducted
before the Physical Configuration Audit if there is any possibility
that amendments will arise as a result of the FCA.
Primary inputs for the
FCA are the functional requirements for the device and test or
operational data showing how the device operates. Functional
requirement information should include verification methods (test,
demonstration, analysis, etc.) and the test method used (if
FCAs may use, but need
not be limited to, data from the following processes and tests:
- environmental testing
- reliability, availability and
maintainability tests and trials
- user trials
- interface checks and tests
- software testing, including independent
verification and validation if safety critical software is
1: If not
already provided, construct a matrix (spreadsheet) showing the
requirements, verification method, and testing procedure name. Ensure
that all requirements have a verification method (and procedure)
columns to the matrix for test status (Pass, Fail, Outstanding Action
Items). Add columns to record other details of interest, such as the
date the test was conducted and the quality assurance person who
witnessed the test. Add a column for information on open action items.
3: Review the
as-run test documentation (or inspection/analysis reports) that are
called out as verifications for each requirement. Record the
appropriate information in the matrix. When reviewing, ensure that the
test was adequate to verify the requirement.
any requirements that are open (failed or outstanding action item).
5: Write a
report documenting the audit and findings.
any findings and other issues with the project.
Audit Report. An Audit Template / Checklist is provided to help you conduct your audit. The template covers all assurance levels and development phases. Tailor the template to fit the needs of the audit
For complex electronics,
the Physical Configuration Audit (PCA) involves comparison of the newly
programmed item against design documentation to ensure that the
physical characteristics and interfaces conform to the product
specification. The first PCA is conducted to show that development is
complete and the item has been built in accordance with its engineering
- FCA report
- Complex electronics requirements
- CE design (HDL models, drawings, etc.)
- Synthesis log files
- Testing and verification reports
- Programming process plan
- Configuration Management records
- Deviations and waivers
- Problem reports
data and documents
2: Review of
FCA report and verify incorporation (or other appropriate disposition) of
action items and findings.
3: Review the
requirements (specification) for the complex electronics against the
design (HDL, drawings) to ensure that the requirements are implemented
in the design.
4: Review any
log files or other documents from the synthesis process or from
developer testing or verification activities. Ensure that no errors
were detected by these processes that were not fixed in the device
5: Review the
process plan for device programming. Ensure that the plan has been
followed, and is programming the chip with the correct code. Review
configuration management records to ensure that the correct design
(code) was used.
problem reports, deviations, and waivers to ensure that there are no
open issues with the complex electronics design or device.
7: Write the
PCA report documenting the process and findings of the audit.
any issues and findings with the project.
Audit Report. An Audit Template / Checklist is provided to help you conduct your audit. The template covers all assurance levels and development phases. Tailor the template to fit the needs of the audit.