| Change control is an aspect of almost every | | | | be administered and should be written in language |
| regulated life science environment. Change control | | | | that will be readily understood by entry level |
| systems allow company employees to quickly | | | | employees. If most employees are not performing |
| observe anomalies that could be harmful not only for | | | | very well on exams and if a level of increased |
| company profits but for human lives. | | | | change control confidence does not manifest itself |
| The control of change, though of the utmost | | | | after training, then chances are strong that the |
| importance, needs to be simple. A recent FDA article | | | | change control training courses need to be clarified. |
| Change Control: Best Practices for FDA-Compliant | | | | 3) More Reporting |
| Medical Device Manufacturers states that "From a | | | | No company wants an enormous amount of change |
| common sense point of view, the system has to be | | | | requests to be filed on a regular bases but a slightly |
| easy to use. If it is so complex that employees feel | | | | increased amount of change control requests may |
| as if they need a Ph.D. or 30 years of experience in | | | | reflect the increased willingness of employees to |
| the industry to figure out whether or not to file a | | | | respond and participate in the change system. |
| change control request, they will avoid or try to get | | | | Increases in reporting may be noted after a change |
| around it. The system for classifying changes must | | | | control system is simplified, or clarified but if a |
| also be simple and easy to use." | | | | company already assesses their own system to be |
| In essence, the FDA is observing that those | | | | significantly simplistic they may want to consider |
| companies with simplistic, easy to understand change | | | | incentives for "watchful change control eyes." These |
| control procedures are those that are more likely to | | | | incentives may result in change control requests |
| succeed in an environment that requires constant | | | | resulting from issues that may have been previously |
| change control vigilance. | | | | ignored. |
| Why does a simplified change control system benefit | | | | 4) Employee Communication |
| life science companies? Some of the following | | | | When a company seeks to simplify their change |
| benefits that stem from a simple change control | | | | control system and encourages occasional (and |
| system may clues to the answer: | | | | scheduled) comments from employees, employees |
| 1) Entry Level Employees Feel Confident Acting in | | | | are not only encouraged to consider change control |
| Accordance with Procedures | | | | more carefully but also enjoy the pleasures that |
| One benefit of a simple change control system is | | | | productive communication within a workplace always |
| that almost every entry level employee will feel | | | | generates. Many employee comments may also result |
| immediately comfortable acting on change control | | | | in "edits" to the change control system that may not |
| procedures. In other words, he or she will have a | | | | have been readily apparent to management as |
| good idea of what to do and what not to do. | | | | necessary measures. |
| To check whether or not a change system is | | | | To increase employee communication, change control |
| sufficiently simplistic, managers should observe | | | | meetings should be scheduled at regular intervals and |
| whether or not entry level employees actually file | | | | participating employees should be duly rewarded for |
| change control requests and whether the change | | | | suggestions that result in helpful shifts in company |
| control requests filed by entry level employees are in | | | | practice. |
| line with company standards. Change control | | | | 5) Advocacy as QA Back-Up |
| managers should also observe whether entry level | | | | Designating high-level employees (such as someone in |
| employees easily comply with change control related | | | | IT or in manufacturing) as advocates for change |
| SOPs and related documentation. If they don't, | | | | control participation discredits the "bad guy" image |
| chances are strong that the employees don't | | | | associated with some QA personnel and encourages |
| necessarily require more training but that the change | | | | employees to participate in change control |
| control system needs to be simplified. | | | | procedures. In change control as in other areas of |
| 2) Easy Training | | | | expertise, more heads can certainly be better than |
| When change control documentation is clear and the | | | | one. |
| system is simple, change control training should be | | | | Conclusion |
| uncomplicated. | | | | Though processes controlling change can make or |
| To determine whether training is simple enough for | | | | break billion dollar enterprises they should remain |
| entry level and experienced employees to | | | | effectively simple and should in addition encourage |
| understand, real-life scenarios should be conducted | | | | employees to participate more readily in change |
| and readily observed by trainers. Exams should also | | | | control practices. |