Understanding Corrective Actions, Nonconformities, and Root Cause Analysis

Are you confused by the difference between nonconforming work and corrective actions? Do you want to learn different methods for performing root causes analysis? If so, then you’ll want to check out our recent webinar on Understanding Corrective Actions, Nonconformities, and Root Cause Analysis with Heather McLemore from A2LA!

Heather McLemore has been with A2LA since 2019. She is an Accreditation Officer II and oversees the AOAC accreditation program. In January 2020 she became a staff-approved lead assessor and has performed more than a dozen quality management system assessments. She has over 8 years’ food microbiology experience, having worked in both beef slaughter and furthered processed meats facilities. This experience allows Ms. McLemore to generate customer confidence with her knowledge of the ISO/IEC 17025 requirements, as well as understand the language used and tests performed by the labs she is responsible for, throughout the entire accreditation process.

In the webinar, Heather spoke about the requirements of ISO/IEC 17025:2017 for nonconforming work and corrective actions and there was a discussion on how to perform a thorough root cause analysis. She also touched on risks and opportunities. While we highly recommend you watch the full recorded webinar, this blog will serve as a brief recap and will cover some of the main takeaways.

To get us started off, Heather took us through a background of ISO/IEC 17025:2017. The 17025 standard represents the general requirements for the competence of testing and calibration laboratories and they were developed in the mid-1970s by experts in laboratory assessment as a way to differentiate between technical competence and specific requirements. Today, the standard has created a global baseline for accreditation. A2LA alone has performed over 2,700 assessments to this standard.

The ISO/IEC 17025:2017 is organized into 8 sections and looks like this. We will bold the areas specifically covered by this webinar:

• Section 1 – Scope
• Section 2 – Normative References
• Section 3 – Terms and definitions
• Section 4 – General Requirements
• Section 5 – Structural requirements
• Section 6 – Resource requirements
• Section 7 – Process requirements
  • Section 7.10 – Nonconforming work
• Section 8 – Management system requirements
  • Section 8.7 – Corrective Action

7.10 – Nonconforming Work

So, let’s start with 7.10. The bottom line of this clause is that a procedure is required in the laboratory. An example of this could be that an incubator temperature was too high, or a pipettor wasn’t calibrated on time. Another example could be that results from a test were emailed when they should have been faxed or called in. Either way, a procedure is required and anything that goes wrong in the lab is considered a nonconformance. Luckily, the standard lists out exactly what we need to have in a nonconfirming work procedure. They are as follows:

• Responsibility/authority for responsibility of NCW;
• Actions based on risk levels;
• Evaluation of significance;
• Includes impacts on previous results;
• Decisions taken on acceptability;
• Customer notification/recall (when necessary);
• Authorization to resume work.

An additional thing to note here is that if there is a chance that the nonconforming work could reoccur, corrective action needs to be implemented. This brings us to our next topic, corrective actions (8.7 in the ISO/IEC 17025 standard).

8.7 – Corrective Actions

Corrective actions are a direct result of nonconformances and their job is to control and correct issues and address consequences. Corrective actions also include an evaluation so you can see what actions need to be taken to eliminate the cause and stop it from happening again in the future. The evaluation piece begins with:

• Reviewing and analyzing the nonconformity;
• Determining the root cause;
• And uncovering whether or not similar nonconformances exist or could potentially occur.

Many people have questions when it comes to the second bullet point – determining the root cause. In the webinar, Heather goes into detail about root cause analysis. But for brevity’s sake, a root cause analysis is really just a system of problem-solving methods aimed at identifying root causes of problems/incidents. Heather noted that one good thing to remember is that there may be more than one cause.

She also went through some of the basic principles of root cause analysis which are:

• The analysis must be performed as an investigation;
• It’s not a blame game;
• Not looking for a quick fix;
• It requires digging;
• Establish a sequence of events that led to the nonconformance;
• And understand the relationship between contributory factors.

Maybe you’re wondering how you can perform a root cause analysis. In the webinar, Heather goes in depth on the best process but here is a general outline:

• Define the problem (this is a result of the nonconformance);
• Gather data/evidence;
  • Records;
  • Documents;
  • Interviews;
  • Flow charts/diagrams;
  • Checklists;
• Identify the causes of the NC;
• What, when, where, and why;
• Corrective actions to prevent reoccurrence.

For more in-depth information on different tips and methods for meeting these requirements of the standard, I’d like to point you toward the full recorded webinar. It is full of great tips/tricks and best practices for ensuring compliance in your organization.

In the second part of the webinar, Karen Arriviallaga, an account executive with Qualtrax, takes you on a tour of our completely customizable eQMS and shows you ways that Qualtrax can help save you time, money, and help take your organization beyond compliance. If you’d like to book a 1-1 demo, reach out to us here!

Categories: Compliance Management, Quality Managers, Risk, Uncategorized

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