MasterControl Change Control™PageTech Paper
Since it’s impossible to avoid change, it is absolutely critical for regulated companies to manage it. In the FDA andISO environments, change must be controlled to prevent unintended consequences in the manufacture of products. Any“unintended consequences,” for example, in a surgical balloon used to open blocked arteries of heart patients, or in atire used in millions of cars worldwide, could have a great impact on public safety. The concept of change control is socrucial that it has been incorporated in a number of regulations enforced by the Food and Drug Administration and in ISOinternational standards.
In manufacturing, change refers to any modication in equipment, raw materials, facilities, utilities, design, formulations,
processes, packaging/labeling, computer systems, and all associated documentation (SOPs, quality manual, etc.). Achange may refer to an updated document, or a simple part replacement, or a totally revamped design. A change may betemporary or permanent, routine or emergency, simple or serious enough to shut down production. It may be caused by a
deviation from an approved regulatory ling or written procedures.
The FDA’s 21 CFR Part 820 requires medical device manufacturers to establish written change control procedures.
Specic requirements are outlined in section 820.30 (design changes), section 820.40 (document changes), and section
820.70 (production and process changes).Written procedures are considered part of the Current Good Manufacturing Practice regulations (CGMP) outlined in 21CFR Parts 210-211, which cover drug and biologic manufacturers. Section 211.100 provides that written procedures,including any changes, should be controlled — meaning recorded, reviewed, and approved by the quality control unit.
Any deviation from written procedures should be recorded and justied.
Manufacturers certied to ISO 9001:2000 and ISO 13485 standards face similar requirements. They are required to ensure
that any changes affecting the quality management system (including product requirements, design, and development
changes) should be controlled. Changes must be reviewed, veried, validated, and approved prior to implementation.
Manual or Hybrid Quality System
Change control is a complex process and an inadequate system can cause internal confusion, noncompliance, or even a product recall or liability lawsuit. Change control can be especially challenging for companies that rely on a paper-basedor hybrid process. Here are some of the characteristics of manual and hybrid systems and the common problems theycause.
– Under a paper-based system, companies are likely to rely on face-to-face exchanges,such as change control board meetings, to discuss changes. The effectiveness of these meetings depends ontheir frequency and the availability of members to meet as emergency changes arise. Lack of communication between departments, failure to follow up or escalate change requests, and delayed or inappropriate
notication of changes made by suppliers are all symptoms of an inefcient system.
– Quality processes that are not connected, as in manual and hybrid systems, arelikely to result in a communication breakdown. In the context of change control, this could mean lack of
follow-up, late notications, and tasks not completed by deadline. Suppliers who are entirely outside thechange control process could be making changes without proper and timely notication.
– Finding the necessary data in a manual process almost always requires more time andeffort, and could result in poor turnaround for change implementation. The problem becomes worse whenthere is an unexpected change — a deviation — and supporting data is not generated in a timely manner.Delays may also result from failure to recognize the urgency of a change and the absence of a contingency plan for certain types of changes.