A vital concept from the chemical process industry, management of change (MOC) relates primarily to safety. It means that whenever we change a factor in a cause-and-effect diagram (e.g., machine, material, manpower, method, measurement, environment, or any other factor), we create risks of unintended and undesirable consequences. The concept, however, carries over into quality as well as safety within every conceivable industry and service.

An outstanding example appears in an article written by Donald Lorenzo, Della Wong, and Mark Suyama for Chemical Engineering Progress. Suppose a chemical plant switches suppliers of an aqueous solution of a caustic (alkaline) chemical, and the new supplier uses the municipal water supply rather than, for example, demineralized water from some other source. This seems harmless, because if we can safely put municipal water into our mouths and stomachs, it shouldn’t be a problem for stainless steel chemical process equipment—or so we might think.

Municipal water contains trace amounts of dissolved chlorine gas to kill off harmful bacteria and make the water safe to drink. This chlorine, while not sufficiently concentrated to harm our bodies, is quite capable of cracking stainless steel piping, especially under elevated temperatures. Although our stomachs are designed to tolerate the hydrochloric acid they produce for digestive purposes, stainless steel isn’t. Seemingly small changes can therefore add up to big trouble.

In her article “Come to Light,” Jayet Moon provides the example of a baby formula container that was made from opaque plastic. The company thought it would be a good idea to make the plastic transparent so the user could see how much was left. However, “After six months, customers complained to the manufacturer that the containers were cracking.” It turned out that the transparent plastic was susceptible to ultraviolet light from the sun and even from incandescent and fluorescent lights. The latter is relatively harmless to most people, but materials are another matter—and the plastics in question could conceivably be damaged by wavelengths that don’t affect people at all. This is another example of a seemingly minor, and ostensibly desirable, change that has unintended and undesirable side effects.

MOC in the pharmaceutical industry and information technology

MOC, or absence thereof, has resulted in Food and Drug Administration (FDA) warning letters. A warning letter to DuPont Nutrition says, “Your firm failed to have an adequate change management program to evaluate and approve changes that may impact the quality of the excipient. Your Avicel process performance qualification studies conducted from 2001 through 2007 identified conductivity as a critical quality parameter. However, in approximately 2011, you removed the (b)(4) conductivity meters without a documented change control.”

Another warning letter to Analytical Food Laboratories requires a “comprehensive, independent assessment of your change management system. This assessment should include, but not be limited to, your procedures to ensure changes, such as changes to or deviations from a validated test method, are justified, reviewed, investigated, and approved by your QU. Your change management program should also include provisions for determining change effectiveness.”

These examples show that MOC is a very important issue. What do ISO 9001, IATF 16949, and the FDA say about it?

ISO 9001:2015, IATF 16949:2016, and the FDA’s Q10 guidance

ISO 9001:2015, clause 8.5.6—Control of Changes, says, “The organization shall review and control changes for the production or service provision to the extent necessary to ensure continuing conformity with requirements” and adds the need to retain documented information. This comes across as addressing only the tip of the iceberg, and it’s why I recommend using the automotive IATF 16949:2016 standard to deal with the rest of the iceberg. It has a lot of good material that ISO 9001 doesn’t even mention and, despite its automotive origins, is largely applicable to all industries.

IATF 16949:2016, clause 8.5.6.1—Control of Changes—Supplemental is far more extensive than ISO’s clause 8.5.6. “The organization shall have a documented process to control and react to changes that impact product realization.” It goes on to require assessing the effects of changes and validating them prior to implementation. This extends to changes made by suppliers.

Temporary changes to process controls (clause 8.5.6.1.1) aren’t left out, either. A documented process is required for managing their use. This process must include risk analysis—noting that FMEA is a way to do this—as well as an internal approval process. Traceability of all the product is involved, such as “verification and retention of first piece and last piece from every shift.” Customer approval of the product also is required.

The FDA’s “Guidance for Industry; Q10 Pharmaceutical Quality System” also goes into far more detail than ISO 9001 (emphasis is mine): “Change Management System (3.2.3)... The change management system ensures continual improvement is undertaken in a timely and effective manner. It should provide a high degree of assurance there are no unintended consequences of the change.”

Where should we look for MOC issues? Although a change in pretty much anything could constitute a risk, the obvious starting point begins with the factors in the traditional cause-and-effect diagram: man, machine, material, method, and environment. Additional issues can arise in metrology, and they are discussed by the Automotive Industry Action Group’s (AIAG’s) Measurement System Analysis manual.

Where to look: Process noise factors and work elements

The AIAG/VDA Failure Mode Effects Analysis Handbook cites man, machine, material, and environment as process noise factors. We saw how a seemingly innocent change to materials—substituting municipal water for a nonchlorinated water source—can damage stainless steel pipes.

The same reference (p. 86) introduces the process work element, “the lowest level of the process flow or structure tree. Each work element is the name of a main category of potential causes that could impact the process step.” It cites man, machine, material, and environment, along with method (i.e., how the job is done) and measurement. These are the same factors we see in the traditional cause-and-effect diagram. We must therefore regard any change, even a seemingly minor one, to any of these things as a potential trouble source, except for replacement in kind.

Replacement in kind

The Lorenzo article uses the important phrase, “replacement in kind,” which AIChE defines further. Replacement of a part with an identical part isn’t considered a change. For example, if a section of pipe is replaced with a pipe of identical materials, inside diameter, wall thickness, and threads or flanges, this is not considered a change. The same would go for replacing a vehicle’s tire with an identical tire.

It’s important to note, however, that replacement in kind assumes that all the associated maintenance tasks, such as tightening the bolts on the pipe’s flanges to the correct torque, or ensuring that the tire is inflated to the correct pressure, are performed correctly. Maintenance and repair, in fact, bring MOC issues with them if they’re not performed consistently.

The same goes for organizational and personnel changes, as pointed out by OSHA in a process safety context, although the concept is applicable elsewhere. OSHA cites the example of reduced staffing, but other changes also are foreseeable. For example, suppose that a process runs like clockwork not because it’s inherently a good process but rather because the employee who runs it has had 30 years of experience and knows exactly how to compensate for any shortcomings or problems. If he or she retires, we might suddenly get nonconformances from all directions. Process failure mode effects analysis (PFMEA) is a good way to address this risk by ensuring control of all relevant process factors by the process’s control plan rather than by human experience.

Process and FMEA implications

Each step of a well-designed process should specify who (the function of the person who does the job), what is to be done, where, when, how, and why. Any change to who, what, where, when, how, and why, and especially to the process work elements, creates risks of unintended and undesirable consequences, and requires a MOC review. Then the FMEA must be updated to reflect the changes and the associated process controls.

This also underscores the need to not deviate from a procedure as it’s written, because a deviation means a change to the process factors. This carries the same risks. Consider the FDA Warning Letter 320-25-22, which includes this finding: “You repeatedly deviated from your validated manufacturing process for the production of (b)(4).” [(b)(4) refers to redacted information.] The validated process accounts for the known risks; the deviation does not, and therefore opens the door to risks that might have never been considered.

Summary

Changes, even those that will purportedly improve quality and customer satisfaction, often entail serious risks of unforeseen, unintended, and undesirable side effects. Therefore, it’s vital to have a process, and preferably a documented one (this is mandatory in IATF 16949:2016), in place to review changes to ensure that they won’t cause problems. My observation is that while IATF 16949 and the FDA give substantial attention to management of change, ISO 9001 gives it far too little emphasis. ISO 9001 is a good starting point, but it’s far from all inclusive.

Product realization changes will likely require assessment and potential revision of the process FMEA. Pay particular attention to the process work elements and all that they imply. The most familiar of these are manpower, materials, machines, methods, measurements, and environment, but others also can be applicable.

References

Allcock, Harry R. Introduction to Materials Chemistry (Wiley, second edition, 2019)

Lorenzo, Donald; Wong, Della; Suyama, Mark. “Recognize Hazards to Recognize Change.” Chemical Engineering Progress, April 2015, pp. 40–44 (requires membership to view)

Moon, Jayet. “Come to Light.” Quality Progress, January 2023, pp. 20–27 (requires membership to view)