AS9101 is the audit companion to AS9100. A sector scheme of ISO 9001, AS9100 is used in the aerospace and defense industries. Certifying bodies (CBs) use AS9101 as a guide for auditors using AS9100. AS9101E, released just this month, seems to offer a vast improvement over all previous versions of AS9101.
Revision E removes the temptation to use AS9101 as stage 2 audit criteria, while at the same time further promoting a process approach to auditing, being clear about the importance of stage 1 auditing.
STAGE 1
AS9101E requires the auditor to find evidence that the requirements of AS are addressed by documented QMS procedures at stage 1 (4.3.2.2 d). So, auditors will actually need to read auditees’ QMS documentation, interpret it, and vet it against AS 9100 requirements during stage 1 to produce this evidence. Presumably, 6-procedure-only systems will not demonstrate conformity here, as they don’t exhaustively address applicable requirements. They don’t provide the requisite evidence of addressing product realization requirements.
Requirements for documentation describing the processes, and their sequence and interaction (4.3.2.2 b), if effectively applied, should eliminate clause-by-clause procedures. Clause-by-clause procedures don’t effectively describe QMS processes, let alone their sequence and interaction.
If a QMS procedure is dedicated to a requirement instead of a process, it shouldn’t take completion of a PEAR form (process effectiveness assessment report) to notice that the process documented by the QMS procedure is not an effective QMS process. Effectively, it’s a non-process. QMS documentation including non-processes among real processes needed for the system do not effectively describe the system.
STAGE 2
As was true with AS9101D, stage 1 must be done separately from stage 2. AS9101E tells us that at Stage 2, elements of the QMS are audited (4.3.3) (so conformity to the standard is not the focus here), telling us that audit findings should reference process documentation (presumably as opposed to AS requirements).
So, auditors should not arrive at Stage 2 with an AS9100C or AS9101E checklist in hand, and they shouldn’t be writing stage 1 findings (against AS requirements) during stage 2 auditing. Stage 2 audit findings should be written against process documentation, documentation previously verified to be complete and compliant and stage 1. They’re findings that working practice doesn’t comply with the planned arrangements previously found to satisfy AS9100 requirements.
Findings against AS9100 requirements—raised when planned arrangements don’t demonstrably satisfy requirements—should be raised during stage 1 document review, while conformity to AS requirements is being assessed. Only after QMS documents demonstrate conformity to requirements does stage 2 commence. Then at stage 2, personnel need only demonstrate conformity to their planned arrangements (which is the focus of the auditor).
Notice auditors using AS9101D as stage 2 audit criteria won’t be able to use AS9101E as audit criteria. Unlike AS9101D, AS9101E doesn’t contain a clause-by-clause elaboration upon each requirement of AS9100C (thankfully). Auditors seem to think that by using AS9101D as stage 2 audit criteria, they were doing a more thorough audit than ISO 9001 auditors would but they were simply doing a more detailed standard-based audit—as opposed to a process audit.
Hopefully ISO and other sector scheme auditors will follow suit and recognize the importance of a clear two-stage approach to auditing and in particular the importance of document review during stage 1 auditing. Stage 2 is much easier for everyone if stage 1 is done properly.
Now the question is, will CBs consistently understand and comply with the intent of AS9101E?
Bio:
T. D. (“Dan”) Nelson is a quality management consultant, author, and trainer specializing in the process approach, ISO 9001, and related sector schemes. Dan has roughly 20 years of experience with ISO 9000 and over 15 years’ experience with the process approach. Dan holds an MA in Business Administration from the University of Iowa. Dan can be reached at:
dan@tdnelson.com
319.210.2642