Root Cause Analysis & ISO 9001:2015
Difference between Correction and Corrective Action
Amelia Fisher, Audit Manager
Last week, I wrote about the different methods of Root Cause Analysis (RCA), and now want to explain why RCA is needed in order to conform to the requirements in ISO 9001:2015. ISO 9001:2015. Clause 10.2 requires you to analyze the root cause of any nonconformities identified within your Quality Management System (QMS). The specific requirement is to initiate corrective action to address nonconformities. Corrective action comes in two parts; correction & corrective action.
The main difference between a correction and a corrective action is that a correction is a short term “fix” to a problem. It is an immediate action to contain the issue causing a nonconformity. This allows the process to continue with close attention on the action taken for the quick fix, but it doesn’t SOLVE the problem. Corrective action is required to prevent the nonconforming issue from resurfacing and this is where RCA is required.
Corrective action is using root cause analysis to get to the source of why the nonconformity occurred and then determining a way or ways to prevent it from happening again in the future. This step requires a bit more digging to get to the source of what initially caused the issue, but the outcome is worth it. By finding the root cause of the nonconformity you can not only prevent that issue from recurring, but there is potential for this fix to additionally impact other processes or issues in your QMS.
In order to conform to ISO 9001:2015 clause 7.2 (a)’s competency requirements, individuals doing work which affects the management system, such as implementing corrective action, must be properly “competent on the basis of appropriate education, training, or experience”. Additionally, clause 7.2 (d) requires that an organization keep documented information as evidence detailing the competence of personnel. In short, individuals responsible for the organization’s corrective action process must possess and have documented their appropriate knowledge, skills, and abilities to perform the associated tasks. Common forms of such documentation may include training certificates or records as well as performance evaluations or past project data.
No matter how you look at it, correction, corrective action, and root cause analysis go hand in hand. It is important to know the difference between the type of correction you apply to a nonconformance as they will both come in handy at different times throughout your organization’s continuous improvement. Equally important is the competence of the employees or consultants you have affecting the performance and effectiveness of your QMS.
TACG offers training to get your employees the competence they need. If you’re concerned about your organization’s compliance with any of these requirements, please reach out to me directly at 937-974-7950 or firstname.lastname@example.org.