5 Benefits of a Simplified Change Control System that Encourages Employee Participation

Change control is an aspect of almost every regulated life science environment. Change control systems allow company employees to quickly observe anomalies that could be harmful not only for company profits but for human lives.

The control of change, though of the utmost importance, needs to be simple. A recent FDA article Change Control: Best Practices for FDA-Compliant Medical Device Manufacturers states that "From a common sense point of view, the system has to be easy to use. If it is so complex that employees feel as if they need a Ph.D. or 30 years of experience in the industry to figure out whether or not to file a change control request, they will avoid or try to get around it. The system for classifying changes must also be simple and easy to use."

In essence, the FDA is observing that those companies with simplistic, easy to understand change control procedures are those that are more likely to succeed in an environment that requires constant change control vigilance.

Why does a simplified change control system benefit life science companies? Some of the following benefits that stem from a simple change control system may clues to the answer:

1) Entry Level Employees Feel Confident Acting in Accordance with Procedures

One benefit of a simple change control system is that almost every entry level employee will feel immediately comfortable acting on change control procedures. In other words, he or she will have a good idea of what to do and what not to do.

To check whether or not a change system is sufficiently simplistic, managers should observe whether or not entry level employees actually file change control requests and whether the change control requests filed by entry level employees are in line with company standards. Change control managers should also observe whether entry level employees easily comply with change control related SOPs and related documentation. If they don't, chances are strong that the employees don't necessarily require more training but that the change control system needs to be simplified.

2) Easy Training

When change control documentation is clear and the system is simple, change control training should be uncomplicated.

To determine whether training is simple enough for entry level and experienced employees to understand, real-life scenarios should be conducted and readily observed by trainers. Exams should also be administered and should be written in language that will be readily understood by entry level employees. If most employees are not performing very well on exams and if a level of increased change control confidence does not manifest itself after training, then chances are strong that the change control training courses need to be clarified.

3) More Reporting

No company wants an enormous amount of change requests to be filed on a regular bases but a slightly increased amount of change control requests may reflect the increased willingness of employees to respond and participate in the change system.

Increases in reporting may be noted after a change control system is simplified, or clarified but if a company already assesses their own system to be significantly simplistic they may want to consider incentives for "watchful change control eyes." These incentives may result in change control requests resulting from issues that may have been previously ignored.

4) Employee Communication

When a company seeks to simplify their change control system and encourages occasional (and scheduled) comments from employees, employees are not only encouraged to consider change control more carefully but also enjoy the pleasures that productive communication within a workplace always generates. Many employee comments may also result in "edits" to the change control system that may not have been readily apparent to management as necessary measures.

To increase employee communication, change control meetings should be scheduled at regular intervals and participating employees should be duly rewarded for suggestions that result in helpful shifts in company practice.

5) Advocacy as QA Back-Up

Designating high-level employees (such as someone in IT or in manufacturing) as advocates for change control participation discredits the "bad guy" image associated with some QA personnel and encourages employees to participate in change control procedures. In change control as in other areas of expertise, more heads can certainly be better than one.

Conclusion

Though processes controlling change can make or break billion dollar enterprises they should remain effectively simple and should in addition encourage employees to participate more readily in change control practices.

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