Root Cause Analysis and ISO/IEC 17011:2017

Radio legend Paul Harvey had a signature style in all his broadcasts. After he presented the known facts of the narrative, he would pause, lower his voice, and intone, “And now the REST of the story…” Applicants for certificate program accreditation by ANAB might feel like they’re being featured on the Paul Harvey show, because when the assessment team identifies a non-conformity (a situation in which the applicant hasn’t provided evidence that every element of the ANSI/ASTM E2659 Standard is being followed, their first priority is to provide that evidence. Once it’s been submitted, they might think that they are finished, and that accreditation is automatic. So, they may be surprised when the assessment team asks for “the rest of the story.”

One critical component of the assessment process is detailed in ISO/IEC 17011:2017 – Conformity assessment – Requirements for accreditation bodies accrediting conformity assessment bodies.

“7.6.8 When nonconformities are identified, […] The accreditation body shall require the conformity assessment body to provide an analysis of the extent and cause (e.g. root cause analysis) of the nonconformities and to describe within a defined time the specific actions taken or planned to be taken to resolve the nonconformities.”

Stated more plainly, when ANAB (the accreditation body) identifies a nonconformity in the applicant’s (the conformity assessment body’s) operations, ANAB assessors are obligated to obtain a root cause analysis from the applicant that explains why the nonconformity occurred and how it will be corrected.

Root Cause Analysis

A root cause is a factor that caused a nonconformance and should be permanently eliminated through process improvement. The root cause is the core issue—the highest-level cause—that sets in motion the entire cause-and-effect reaction that ultimately leads to the problem(s).

Root cause analysis (RCA) is a collective term that describes a wide range of approaches, tools, and techniques used to uncover causes of problems. Some RCA approaches are geared more toward identifying true root causes than others, some are more general problem-solving techniques, and others simply offer support for the core activity of root cause analysis.

There are several RCA approaches and tools, including but not limited to 5 Whys and Fishbone Diagrams Neither ISO/IEC 17011:2017 nor ANAB require that clients use a specific approach, only that the RCA be conducted and that the corrective actions taken are chosen as a result of the RCA. Of course, evidence of both the analysis and action steps must be submitted to the assessment team.

A Real-Life Example

This is how these principles come into play in a real accreditation example.

Nonconformity

In annual surveillance, a nonconformity was identified for Item 5.8.4: the client did not maintain a record of complaints received within the past year, and any follow-up action.

Root Cause Analysis using 5 Whys

Q1.         Why is there no record of complaints?

A1.         The complaint resolution process does not specify that a log be kept.

Q2.         Why doesn’t the complaint resolution process specify that a log be kept?

A2.         The individual who formerly dealt with complaints kept a hand-written log of complaints. When he retired, his replacement was not informed of the need to keep a log. Therefore, when she documented the process, she didn’t include logging the complaint as a step in the process.

Corrective Action

The complaints process has already been revised to include a logging step, and the individual who processes complaints has been formally notified of the change.

The root cause analysis and the corrective actions taken as a result of the findings of the RCA meet the Standard.

Next Steps

  1. ANAB highlights the requirement in communications to applicants.
  2. ANAB provides training on the RCA requirement for assessors.

Clearly communicating this element of ISO/IEC 17011:2017 to both assessors and clients not only meets ISO/IEC 17011:2017, but it also assists clients in continuously improving their processes. As always, the emphasis is on continuous progress, not instant, perfect compliance. ANAB stands ready to respond to questions and requests for information from assessors and clients alike.

Contributing Author: Dan Hiltz, PhD

Dan Hiltz, PhD Dan Hiltz is a global speaker, coach, and consultant who focuses on individual and team performance. He’s been recognized by Training magazine, eLearning, and Chief Learning Officer. His crusade for supercharging leaders has taken him to 32 states in the US and 13 countries on 4 continents. Dan is a graduate of Thomas More University in Crestview Hills, KY, and holds a masters and doctorate from the University of Notre Dame. He is also an assessor for the ANSI National Accreditation Board (ANAB). His personal accreditations include: Gallup Certified Strengths Coach CompTIA Certified Technical Trainer (CTT+) Certified Healthcare Financial Professional (CHFP) Dan can be reached at dan@leadershipsquared.com.

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