ISO 9001:2000 - ISO 9000 2000 Auditing
Appendix - The Process Approach
Clause 0.2 talks about the
process approach. What this means is that the production of product,
or delivery of service, results from a series of operations, some of
which are sequential and some of which are parallel. However, all are
needed to be successful, and, all are linked in some manner or to some
degree.
Auditing to the 1994 revision level of ISO 9001 was mostly done element-by-element
or clause-by-clause. Some called this the “silo approach to business”
in that the activities of the various processes within an organization
could be evaluated for conformance on a stand-alone basis, oftentimes
without regard for the relationship with other processes. The process
auditing approach is different. Simply stated, it is an approach to
auditing that can start with any process, with audit trails that can
go backward, forward, or sideways. In so doing, the auditor will assess
not only the conformance of the production process, but also those processes
that feed or draw from it, as well as those that support it. Following
are four simplified examples for demonstration purposes:
Example:
The A&A
Screw Machine Company designs and manufacturers specialty fasteners.
It has the following departments: sales, design, purchasing, manufacturing,
shipping and receiving, quality control, administration (including management),
human resources. The manufacturing department has the following operations:
Op-1 (screw machine); Op-2 (precision machine), Op-3 (identification
stamping), Op 4 (degrease and clean), Op-5 (plating), Op-6 (packaging).
Approach 1:
The auditor may start at Op-2.
Information is gathered, such as part number, operator name, identification
of gages in use (if any). While at Op-2, the auditor could assess the
conformance of the operation to planned arrangements. From there, the
auditor could move “‘upstream” to Op-1 and determine if this operation
was in conformance before product was moved to Op-2, or move “downstream”
to assess how the product from Op-2 is handled to assure conformance.
The auditor could also go to human resources and verify the qualifications
of the operator and go to the quality control department to verify the
calibration of gages.
Approach 2:
Similar to Approach 1, start
at Op-2, gather information, assess Op-2 for conformance. Move on to
engineering (design) and assess the effectiveness of the design process.
From there, go to purchasing to assess supplier qualifications. Move
on to receiving to determine if the material being utilized at Op-2
was conforming as received.
Approach 3:
Start with management review
records. Take note of objectives. Move to those functions where monitoring
and measurement are occurring. Compare current results with objectives.
Look at the minutes of management review meetings. If there were any
actions planned, follow up to determine status. Assess the process whereby
resource needs are defined and allocated. Determine if planned actions
have taken place and if results are as expected.
Approach 4:
Start with customer complaint
records. Determine if root causes have been identified. Assess the validity
of any corrective and resultant preventive actions. If operator training
was required, move to human resources to check records. If material
changes were recommended, move to engineering to determine if the specifications
have been changed. Move on to purchasing to determine if revised material
is ordered and if receiving criteria have been changed to reflect the
revision.

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