FAQs – Understanding Root Cause Analysis
Do we need to ask the site the method(s) they used?
It is useful to ask the site which method or approach they use to root cause analysis. However, it should be remembered that there are lots of different ways of establishing the root cause and the
Standard does not limit the technique(s) that can be used.
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Does the completion of the root cause analysis have to be done within 10 days and to presented to the auditor with corrective action evidence within 28 days?
Following an audit, the site will need to complete several activities within 28 days:
Close out the immediate corrective actions and provide suitable evidence of completion to their Certification Body.
Complete the root cause analysis and compile the proposed action plan.
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Do all the actions in the proposed action plan have to be completed within 28 days?
Within 28 days of the audit the root cause analysis must be completed and the proposed action plan compiled. However, it is not necessary for every action in the proposed action plan to be completed within the 28 days.
The proposed action plan should contain clear timescales that indicate when each action will be completed.
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Following on from the previous question, please confirm that the permanent solution can go beyond the 28 day mark so long as there is an action plan for implementation. Also, who decides how long after the required 28 days the client has for implementing the complete solution?
The site has 28 days to complete the immediate corrective action and notify the Certification Body of the action completed.
Within the same 28 days, the site must also complete their root cause analysis and compile a proposed action plan. The proposed action plan must include the timescales whereby the individual actions to address the root causes will be completed. These actions can have timescales beyond the 28 days where this is justified. It is the responsibility of the site to ensure that realistic timescales are chosen.
Obviously, if the action has not been completed by the following audit or if there is evidence that the proposed timescales were exceeded, then the auditor will need to assess whether there is evidence of a non-conformity against one of the clauses of section 1 of the Standard (e.g. 1.1.10 or
1.1.5).

FAQs – Understanding Root Cause Analysis
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Should you give a non-conformance for poor root cause analysis?
If the root cause is poor then the auditor will need to establish whether there is evidence of a nonconformity, for example against clause 1.1.10 or 3.7.1 of the Standard.
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What do you do if there are several root causes?
Firstly, you need to establish if each suspected root cause is genuinely a cause of the nonconformity (i.e. you should obtain objective evidence or data).
For each genuine root cause, the investigator will need to establish the controls or changes that are required to prevent re-occurrence of the non-conformity. These will be documented in the proposed action plan.
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If root cause analysis identifies several causes, is it worth putting a weighted value on those causes?
Some actions will be easier and quicker to complete than others and it is therefore logical to ensure these are completed in a timely manner. However, it must be remembered that the nonconformity will not be completely controlled and prevented until all the causes have been managed.
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Sometimes the root cause analysis leads to huge investment e.g. a change of technology; should monitored corrective action be used in the meantime?
If a specific, proposed action requires considerable time to implement, then the site should consider whether the introduction of an interim measure, for example additional monitoring, is appropriate to prevent the non-conformity until the permanent solution is available.
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Is it worth getting the production team and operators involved in the RCA process?
For some non-conformities it will be possible for the root cause analysis to be completed by an individual (eg the site’s technical manager). However, on many occasions it will be valuable to have a team of colleagues, which could for example include, technical, QA, production, engineering or experienced operators in the implicated area.
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FAQs – Understanding Root Cause Analysis
What happens if the root cause analysis genuinely suggests that human error was the cause e.g. an experienced member of staff forgot?
It must be remembered that the purpose of root cause analysis is not to attribute blame, but to identify the systems, processes or procedures that allowed the error to occur. For example, if an operator forgot to complete routine metal detector checks and this subsequently resulted in a nonconformity, then the site might review line start up procedures, end of production/shift activity such as a sign-off of production records (including metal detection), staff training procedures and the scope of internal audits.
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