Requirements traceability in AS9100D

Suited to its products and services, the organization plans, runs and controls configuration management so that physical and functional attributes are identified and controlled over the whole product life. This controls product identity and traceability back to requirements, including carrying out identified changes, and keeps the documents (requirements, design, verification, validation and acceptance records) in step with the actual attributes of what is delivered.

Held text: AS9100D, our statement of the clause, not the instrument verbatim.

what an assessor asks to see Configuration management process and configuration records showing as-designed, as-built and as-delivered consistency.

where it usually breaks Design changes implemented without configuration identification.; Documentation not matching the delivered configuration.

Every AS9100D clause we hold

The design and development process is controlled so that: the intended results are set out; reviews judge whether results can meet requirements; verification confirms that outputs match inputs; validation confirms that the resulting products satisfy the requirements of their intended use; problems are acted on; records are kept; and, under 9100, authorization is given before moving to the next stage, with people from the functions involved in the stage under review taking part in design reviews. 9100 adds that tests needed for verification and validation are planned, controlled, reviewed and documented, so that: test plans name the item tested, the resources, the aims, the conditions, the parameters to be recorded and the acceptance criteria; test procedures explain how the test is run and performed and how results are recorded; the right configuration is presented for test; the plan and procedures are followed; and the acceptance criteria are satisfied. Equipment used to measure tests is controlled under 7.1.5. When design is complete, reports, calculations and test results show that the design satisfies the specification under every operating condition identified.

Held text: AS9100D, our statement of the clause, not the instrument verbatim.

what an assessor asks to see Design review, verification and validation records with stage authorization.; Test plans and procedures meeting a) to e) with configuration of the test item recorded.; Completion evidence covering all identified operational conditions.

where it usually breaks Design reviews without representatives of manufacturing or quality.; Tests run on an undocumented configuration.; Next stage started before authorization.

Every AS9100D clause we hold

Changes made during or after design and development are identified, reviewed and controlled to ensure no adverse impact on conformity, with documented information retained on the changes, review results, authorization and actions taken to prevent adverse impacts; 9100 adds a process with criteria for notifying the customer before implementation of changes affecting customer requirements, and that design changes are controlled under the configuration management process.

Held text: AS9100D, our statement of the clause, not the instrument verbatim.

what an assessor asks to see Design change records with review, authorization and impact actions.; Customer notification criteria and records.; Configuration management linkage.

where it usually breaks Changes affecting customer requirements implemented without prior notification.; Design changes outside configuration control.

Every AS9100D clause we hold

Inputs to design and development are identified as the requirements that matter for the particular kind of product or service, taking account of: functional and performance requirements; what was learned from earlier, similar work; statutory and regulatory requirements; codes of practice or standards the organization has undertaken to apply; what could result from failure; and, under 9100, what could result if materials, processes, components, equipment or products become obsolete. Inputs must be adequate, complete and unambiguous, conflicts among them must be settled, and records kept. Benchmarking, feedback from providers, internal data and data from products in service may also serve as inputs.

Held text: AS9100D, our statement of the clause, not the instrument verbatim.

what an assessor asks to see Design input records including obsolescence consequences and resolution of conflicting inputs.

where it usually breaks Obsolescence of components not considered at design input.; Conflicting inputs unresolved at release.

Every AS9100D clause we hold