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(by Choong Ewe Lee)


Many of our clients found difficult to understand the reason of having this requirements, as the standard requires the IATF certified organization to have a back-up alternative for process control. That's meant, we shall not only have a primary process control, but we shall also need to prepare for back-up process control plan for emergency. If there is any emergency happened to primary processes, such as breakdown or whatsoever reasons, we will have immediate back-up plan to assure the continuity of product supply to customer.

Would this only apply to production processes only ?


No. the alternative process control shall also include inspection, measuring, testing and error proofing devices. However, we have proposed our clients to generate alternative method for those key process equipment only or those specially requested by the customer. And, the alternative method for process control shall be prepared based on the risks analysis (such as Risk & Opportunities Assessment, FMEA, etc), and its severity, at the absence of primary process control.


So, any additional commitment by having this clause requirements?
•    The list of approved Alternative Control Methods shall be maintained in the Master List.
•    The above list shall be updated from time to time, and reviewed at least once a year.
•    The alternative process control methods shall be stated in the Control Plan which is applicable.
•    The Work Instruction shall be available for each process control method.


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