by Denise Robitaille
They used to be called “observations.” Then they became “opportunities for improvement”—later reduced to the ubiquitous acronym OFIs—and were finally pronounced “ofee” by some. Regardless of what they’re called, there’s an unresolved question of how auditees are supposed to treat them.
Most certification bodies don’t require auditees to respond to opportunities for improvement. What then is the expectation? First, let’s discuss the nature of OFIs when they’re incorporated into audit reports. They generally relate to a perception of risk or concern about an inadequacy that falls short of nonconformity. Straddling the chasm between articulation of an actual nonconformance and the temptation to consultancy, OFIs inhabit a nebulous, ill-defined domain.
How auditors use OFIs
Some auditors avail themselves of this device to make note of small glitches—single anomalies that, while technically nonconforming, are of a miniscule nature and have no perceptible consequence for the quality management system (QMS), the product, or the customer. A typical example might be a notation that the footer for an infrequently used form doesn’t reflect the latest revision.
Some auditors use OFIs to make suggestions, a practice I believe is nothing more than thinly veiled consulting and inappropriate for third-party assessments. For example: “The client should put the resource needs next to each action item in management review.” This is simply the auditor’s opinion of how the company should organize and track information. The organization’s managers can put the information anywhere they want as long as it fulfills requirements and works for them.
Finally, there are auditors who utilize OFIs as they were intended. They employ OFIs to address an often undervalued purpose of auditing: to assess the effectiveness of the QMS and its processes. It’s possible for a process to conform to specified documentation and yet not be effective. For example, a client may use a sampling plan as documented in the organization’s procedure. So, the process conforms to documented requirements. However, if the sampling plan isn’t sufficiently robust, it may not be effective in preventing the organization from shipping defective products or it may increase the likelihood (risk) that product defects won’t be detected until the organization has invested considerable time, raw material, and labor into parts that will either need to be reworked or scrapped. An OFI in this instance might read: “There is a concern that the sampling plan utilized is not adequate to ensure that the organization doesn’t manufacture and ship defective parts.”
Note that there is neither the whisper of a recommendation nor a statement of nonconformance. That’s what objectively stated OFIs should reflect. It indicates that there is a potential for something to go awry due to the questionable effectiveness of a process.
How then should an auditee respond? Historically, most, if not all, registrars have told clients that they are not obliged to respond to OFIs. However, that doesn’t mean they should be ignored. Most auditors are conscientious about citing opportunities for improvement and wouldn’t bother to include them in an audit report if they had no value. This is the auditor’s best shot at being helpful without usurping the organization’s right and responsibility to decide how best to address perceived risks.
I generally tell clients that although they are under no obligation to respond, it’s in their own best interest to give careful consideration to OFIs. Good auditors are adept at assessing risk and effectiveness. The OFIs usually have merit. Even if the client’s ultimate decision is to do nothing, the discussion itself has inherent value because it encourages dialogue and fosters more understanding of the organization. More often than not, I find that auditees will heed the words of the auditor and somehow address the risk.
Recently, during a surveillance audit, I had a client proudly tell me that she’d initiated a preventive action that was truly helpful based on an OFI that I had raised during a previous audit. It had improved the effectiveness of their process for monitoring suppliers.
Auditors should understand the intent of OFIs and use them judiciously to help auditees. Auditees should also understand OFIs’ intent and take the best action for their organization based upon deliberation of what has been responsibly—and objectively—observed by the auditor.
About the author
Denise Robitaille is the author of 10 books on various quality topics. She’s an internationally recognized speaker who brings years of experience in business and industry to her work in the quality profession. As the principal of Robitaille Associates, she has helped numerous companies in diverse fields to achieve ISO 9001 registration and to improve their quality management systems. Robitaille is vice chair of the U.S. TAG to ISO/TC 176, the committee responsible for updating the ISO 9000 family of standards. She’s also a RABQSA-certified lead assessor, an ASQ Certified Quality Auditor, and a fellow of ASQ.
Her books include The Corrective Action Handbook, The Management Review Handbook, The Preventive Action Handbook, Root Cause Analysis, Managing Supplier-Related Processes, and Document Control, all published by Paton Professional. She also co-authored The Insiders’ Guide to ISO 9001:2008.
Her newest book, 9 Keys to Successful Audits, is available now.
Tags: OFIs, opportunities for improvement.