FDA & ISO Change Control
Manufacturers certied to ISO 9000:2000 and ISO 13485 standards are required to ensure that any changes affecting thequality management system (including product requirements, design, and development changes) should be controlled.The underlying message in these regulations is that all changes should be made according to approved (approval impliessuccessful testing or thorough review/investigation) written company policies and procedures. Change control procedureshave to be written as a way of standardizing instructions. Written procedures are also more reliable compared with passingon information verbally. “Uncontrolled” change in this context refers to modications made without review and approvalof the quality control unit and other departments affected by the change.In the FDA and ISO environments, strict adherence to approved policies and procedures is key in keeping manufacturingoperations in a state of control and it is what makes change control crucial.
Elements of Change Control
Change is typically introduced by an initiator or originator. Depending on the company and industry, the initiator mayor may not be the person who will carry the change through implementation. Initiating a change usually involves llingin a change request form, which then moves through a process or system of review and approval. Most organizationshave a change control committee or board, which may be a single entity for an entire company, or there may be onefor a company’s every manufacturing site. The committee usually includes representatives from different departmentsinvolved in production, such as quality, manufacturing, regulatory affairs, and engineering. Depending on the change, thecommittee may also involve legal, sales, or marketing departments.For pharmaceutical companies, the CGMP requires that all changes should be reviewed and approved by the qualitycontrol unit. In these companies, there may be a “change administrator,” a role usually assumed by the quality unit.Change control records usually cover: identication of the item/entity being changed, a description of the change,identication of the affected documents, signatures of the approvers, approval date, and effective date.In the medical device industry, each modied device, accessory, labeling, packaging, and process must be thoroughlyveried and or/validated by the appropriate department. The change control committee then reviews the test results andother pertinent information.
A change control system is necessary to prevent inappropriate modications. While this sounds simple, implementationcan be complex and an inadequate system can cause internal confusion, noncompliance, or worse, a product recall or a product liability lawsuit.What makes change control so challenging? There are many factors, but the following are the most common issues:
– Lack of communication between departments, failure to follow up or escalate changerequests, and delayed or inappropriate notication of changes made by suppliers are some of the communication-related issues that impact the change control process. Companies using a paper-based change control systemare likely to rely on face-to-face exchanges, such as change control board meetings, to discuss changes. Theeffectiveness of these meetings depends on their frequency and the availability of members to meet as emergencychanges arise.
– Timeliness can make or break a product’s chances of succeeding in the market. Companiesthat rely on a manual system to generate data and to route and track submissions and change orders are likely tohave poor turnaround for change implementation because the system requires more time and effort. The problem becomes worse when there is an unexpected change — a deviation — and supporting data is not generated in a