While internal audit is focused on process realization and effectiveness, this second tool actually complements the Internal audit in making sure that hard work done in the internal audit does not goes to waste. It is well know how corrective action is different from correction in terms of focus being the prevention of recurrence of the problem. It is very important that companies make use of this TOOL not only for the nonconformities or gaps identified during the internal audit but also for all kinds of complaints and unplanned emergencies which take away the management’s time. In essence this is one of the most underutilized and ineffectively used tools in the ISO 9001 Toolkit. To be able to gauge effectiveness of Corrective action Process one can have a look at the quality aspects of corrective action process such as , involvement of people, defined methodology, promptness of action, effectiveness of action, No of process identified as being able to affect this Corrective action or non conforming situation and relationship. A simple method to make sure that corrective action is effective is a)
Whether it involves modification of procedure
b)
Whether it involves training /retraining
c) Whether it involves monitoring mechanism to detect the initial non conforming situation and the process because of which the initial non conforming situation occurred. d) Whether it is trying to change the process that could affect the enabling of the initial non conforming situation Many methods can be used for Root cause analysis but a few common ones are 1)
5 Why
2)
FMEA
3)
Fish bone diagram
Though more methods are available but it is easy to use these methods Common Flaws in using Corrective Action Tool: 1) TIMELINE -The most common defect in using this tool is focus on a time frame to come up with a corrective action. Since the management’s focus is to hurriedly close the nonconformities before the management review. 2) SINGLE PERSON RESPONSIBILITY: Another Common flaw is assigning the closure of responsibility to process owner or departmental head only. 3) PROCESS INTERACTION: focusing too much on the process where the non conformity was found and missing out on other possible process that could be indirectly responsible for the creation of circumstances that lead to the occurrence of the non conformity. 4) LACK of TOP MANGEMENT INVOLVEMENT: The top management is not involved in acceptance of the Root cause and Corrective action and most of the times are not able to relate its own responsibility vis-à-vis the occurrence of non conformity Possible KPI for Corrective Action Processes are 1)
New processes or sub processes identified because of Corrective action processes PER corrective action
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2) New monitoring mechanism or reporting mechanism developed because of Corrective action PER corrective action 3)
No of trainings and changes in job description initiated as a part of corrective action PER corrective action
4) No of document changes for procedures and Work Instructions made as a part of corrective action PER corrective action 5) No. of changes in work environment done PER corrective action. Eurotech Training division provides open house and In-house courses for internal auditor for ISO 9001:2015 which focuses on how to conduct Root cause Analysis and Corrective action effectively. For open house ISO 9001:2015 internal auditor course check out our calendar.
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