by Garabet H. Kassakhian, Ph.D.; Clyde M. Hedin; and F. Funda Ristow
Auditors are well acquainted with findings and observations. Findings can be critical, major, or minor infractions of a quality management system’s (QMS) requirements or the quality standard in use for a specific project or for an organization as a whole. Most findings need to be corrected soon after an auditor’s report is issued. When serious enough, infractions should be corrected on the spot, lest further and graver consequences ensue.
Findings may be alleviated through corrective action taken to prevent recurrence by eliminating the cause of a detected nonconformity. To perform corrective action effectively requires the determination of the root cause of the infraction. Findings can also result in a correction, which eliminates the detected nonconformity without requiring the identification of a root cause.
With observations, auditors find themselves in a gray area of overlapping quality-related issues. Observations run the whole gamut, from praising an innovative process and excellence in document control and recordkeeping, to actions that promote good laboratory practices, maintain safety, recognize and document a continual improvement, prevent potential mishaps, and so on.
Observations that require action
Our organization’s internal auditing processes evolved during nine years of working within the framework of an ISO 9001-certified QMS. As a result of this history, we began to distinguish between routine observations and observations that—although not constituting an infraction or nonconformity per se—required action, in some cases as soon as possible.
It’s well known that auditees do not (nor are required to) respond to observations. They are generally ignored by the audit report recipients until the next audit. Therefore, to have an effective internal audit, the auditor must differentiate between observations that require no action and those that require action. We have termed the latter “actionable observations.”
What is unique about actionable observations is that they can only be initiated or generated as the result of an internal audit and they require an implementation deadline just as a correction or corrective action does.
Prior to the creation of the actionable observations category, to obtain action, auditors have been forced to shoehorn observations into corrective action reports (CAR) or nonconformance reports (NCR). This doesn’t sit well with auditees, as receiving a CAR or NCR is generally perceived as a demerit for the operation or process and the operators, i.e., the auditees. The actionable observations category removes this stigma while providing management with an effectively enforceable alternative that promotes tracking and follow-up.
To utilize actionable observations for maximum effectiveness, it’s imperative that staff become stakeholders and support the use and resolution mechanism of this concept. Staff meetings are useful forums to introduce the process and discuss the whys and hows of the implementation.
Examples of actionable observations
Most QMSs require the documentation of continual improvements. Still, a plethora of minor and even some major continual improvements go undocumented because the authors consider them to be common sense, “unworthy” to be elevated to continual improvement status, or because of a lack of time to write them up. When an auditor comes across one of these during an internal audit, it can be written up as actionable observations and a deadline set for documenting the continual improvement that has already been implemented.
As another example, if an organization is experiencing negative customer feedback, a CAR or NCR has been issued, yet the customer feedback (e-mail, teleconference, etc.) might not be documented. These are actionable observations that result in a correction and should be tracked as such.
How to handle repeats?
In the world of ideal audits, findings are documented and tracked in CARs or NCRs, the root causes determined, and the appropriate corrective actions are approved by management. After implementation, the auditor verifies and closes the CARs/NCRs. An effectiveness check is then conducted to validate the usefulness of the implemented action. When a CAR/NCR has not been implemented, a follow-up CAR has to be issued.
Similarly, when tracking actionable observations, the auditor may come across actionable observations that have passed their implementation deadlines, or a follow-up audit uncovers an identical issue. A nonconformance report must be issued to enforce the actionable observations.
To make internal audits more comprehensive and effective, consider implementing actionable observations. These are not QMS infractions that warrant CARs, but could and should be tracked.
About the authors
Garabet H. Kassakhian, Ph.D., is the senior quality assurance officer of the U.S. Environmental Protection Agency’s Quality Assurance Technical Support (QATS) contract with Shaw Environmental Inc. (a subsidiary of The Shaw Group Inc.) in Las Vegas, Nevada. Kassakhian is also the program’s ISO management representative and a trained ISO 9001 lead auditor. Email him at email@example.com.
Clyde M. Hedin is the program manager of Shaw’s QATS Program. Hedin is an ASQ Certified Quality Auditor and trained ISO 9001 lead auditor. Email him at firstname.lastname@example.org.
Funda Ristow is the lead internal auditor of Shaw’s QATS Program. Ristow is a trained ISO 9001 lead auditor. Email her at email@example.com.
Tags: actionable observations.