This text is from the second edition of ISO 9001, The Standard Companion. It is based on the now obsolete 1987 version of the ISO 9001 Standard. The third edition, based on the current 1994 standard, is available from Simply Quality.
Have a procedure for each of the following purposes:
a) Investigating the cause of a bad product and
identifying what process needs to be improved so it won't happen
again.
b) Analyzing processes, work operations, concessions or waivers, quality records,
service reports and customer complaints to detect and eliminate potential
causes of the bad product.
c) Preventing problems consistent with the risk they may
present.
d) Making sure corrective actions work.
e) Recording changes to procedures that result from
corrective actions.
This clause requires continuous improvement of the quality system. Use of the phrase "potential causes" requires corrective action be applied broadly, including diligent review and improvement of processes. It is required not only that the immediate problem be solved but also that actions be taken to prevent similar problems from happening again. Similar problems can be permanently prevented by identifying and correcting the root cause of the problem. Often the root cause can be determined by asking "why did this happen" in a non-threatening way to determine the fundamental cause for each unsatisfactory contributing condition and to identify and understand increasingly useful ways to prevent related problems from occurring. Correct the root cause of the problem promptly when it is discovered.
The following nine corrective action steps are recommended (and further described in ISO 9004): 1) identify the problem, 2) assign responsibility for taking corrective action, 3) evaluate the importance of the problem, 4) investigate possible causes of the problem, 5) analyze the problem, 6) take action to prevent recurrence of this or similar problems, 7) implement new process controls as necessary, 8) determine what to do with the failed items, and 9) record permanent changes in process documentation.
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