Keeping Current

The case for continued professional growth

Written by Bill Aston, Published in ASQ QP Magazine, June 2018.

It sometimes may seem that as soon as an organization becomes familiar with a management system and its requirements, changes must be made to meet newly identified customer requirements or to comply with recently issued editions, revisions, errata or addendums to the standard or specification.

Changes in every industry, standard, specification and code are inevitable. So is the need for quality professionals to keep up with these changes as they occur. Trained and experienced quality professionals—such as quality assurance and quality control managers; health, safety and environmental managers; auditors; and consultants—all play essential roles in the continued success of organizations. It’s vital that they stay abreast of changes in their industry and applicable standards. Management systems are continually changing—and so must the quality professionals who implement, audit and maintain those systems.

Understanding ISO 9001:2015 changes

A quality professional should be his or her organization’s relied-upon source of information and guidance for all things quality related. To be that, he or she must be committed to continually learning new skills and technologies, as well as regularly refreshing his or her existing knowledge and skillsets.

ISO 9001:2015 introduced many changes—a few of which still aren’t fully understood by some quality professionals. For example, I recently attended a standards quality conference and was surprised by the number of attendees who were unfamiliar with ISO 9001:2015’s requirements regarding procedures and records. It seems that removing the words “documented procedures” and “documented records” from the standard continues to be a source of confusion or uncertainty for some people.

Quality professionals who have completed ISO 9001:2015 transition training, or otherwise familiarized themselves with the standard, realize that although some wording has changed, requirements for maintaining procedures and records are still part of the standard.

The September 2015 QP article “Keep Calm and Prepare for ISO 9001:2015” discusses all the significant changes in ISO 9001:2015.¹ The article makes specific reference to the continued requirements for procedures and records, as defined in ISO 9001:2015, Annex A6.

While ISO 9001:2015 no longer identifies six documented procedures to be maintained, like previous versions of the standard did, the responsibility has been appropriately placed on the organization to determine the procedures and records that it requires to address identified risks and opportunities. This is the main point of mandating risk-based thinking (RBT): to identify and address (control) risks and opportunities.

An organization must determine its internal and external risks and opportunities via RBT and ensure they are addressed. The organization isn’t required to perform a formal risk assessment, but it should be able to demonstrate how risks are identified and addressed.

It’s important to keep in mind that ISO 9001:2015 is a generic standard for quality management systems (QMS). Every organization is responsible for determining the QMS standard that best matches its needs based on known risks associated with the industry or customer, or the product or service provided.

Consider the oil and gas industry, in which risk and the consequences of loss could be devastating to human and animal life, as well as the environment. In this case, more rigid standards, such as American Petroleum Institute (API) Q1, API Q2, API 18LCM or ISO technical specification 29001, are more suitable than ISO 9001:2015. These quality systems are more prescriptive and specific to address risks in the oil and gas industry.

The future belongs to the prepared

Today, auditors are expected to possess knowledge and skills that go well beyond yesterday’s audit practices of verifying the availability of a quality manual and the required six procedures.

An auditor must be able to evaluate an organization’s use of RBT and understand the risk assessment process, which includes risk identification, analysis and evaluation, and root cause analysis strategies. The effectiveness of the quality professional is based on his or her knowledge of these and other management tools.

Consider this: What if you had a medical, financial, legal or other family services provider that didn’t stay abreast of the latest technologies or other changes in their areas of expertise? Imagine the potential effect that could have on your well-being.

It’s similar with an organization that depends on competent and experienced quality professionals to ensure reliable information is provided to management, which facilitates fact-based decision making.

Obtaining new skills to meet updated standard or specification requirements, along with periodic refresher trainings to maintain existing skills, are essential for quality professionals to remain relevant in their organization and to their client base. Today’s quality professionals must rethink and retool their existing knowledge base and skillsets to prepare for a new approach to auditing and quality management. There’s a lot to know, and learning must be continuous.

Reference

1. Bill Aston, Susan L.K. Briggs, Charles A. Cianfrani, Deann Desai, Allen Gluck, Paul C. Palmes, Denise Robitaille and John E. “Jack” West, “Keep Calm and Prepare for ISO 9001:2015,” Quality Progress, September 2015, pp. 18-28.