Special Processes

Some organizations are unsure if ISO 9001:2008, clause 7.5.2, is applicable to their quality management system. For a production process, if its resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies only become apparent after the product is in use, the process must be validated. The Aerospace standard, AS9100:2009, clause 7.5.2, states in a Note that these processes are often referred to as “special processes”.

The Aerospace standard on audit requirements, AS9101:2010, states in clause 4.2.2.8, that when special processes are identified in the audit plan, the audit team must evaluate the process validation, as well as, the monitoring, measuring, and control of these processes.

To verify the validation of special processes, the process records must be reviewed for each audited special process, including a comparison of the actual and planned results.

To verify the monitoring, measurement, and control of special processes, the audit team must identify the process requirements, including customer requirements, for the special processes. For the sampled processes, the audit team must assess the monitoring and measuring equipment used (e.g., calibration, accuracy) and the method for recording results. If required, the traceability between the process (e.g., batch or load charge identification) and the resulting products are to be verified.

For outsourced special processes, the audit team must verify the organization’s supplier control process addresses these items. In addition, the audit team must review the use of customer-designated sources, as required.

AS9101:2010 includes a Note that states special processes are managed by using personnel qualified as required by the organization and/or customer requirements, and by controlling physical or chemical process characteristics, e.g., temperature, time (process duration), pressure, chemical composition of product or process treatment material (surface treatment solution).