To function efficiently and adhere to industry norms and laws, any organization must have regulation, compliance, and change management in place. Quality control laboratories must use best practices in these areas to achieve success and steer clear of potential traps in today’s constantly changing regulatory environment. This article will examine the main tactics and techniques that labs may use to handle compliance, regulatory, and change management procedures in an efficient manner. We will also discuss how these tactics and approaches can enhance operational effectiveness, reduce risk, and foster overall continuous growth.
Below are a few best practices for running a rugged and efficient change-control framework.
Change management effect assessment: In numerous cases, proposed changes are not appropriately and completely studied for the risk. Quality Assurance department should consistently access changes to decide their expected impact on the following processes
1) its effect on well established validated process and validated system, 2) Secondly its effect on critical instruments used in production, quality and its related departments and 3) its effect on product quality, 4) Finally on its effect regulatory impact.
Documentation in Change management: In any organization before initiating changes, it is often widely discussed and is clearly understood among the all the staff members involved. In regards documentation, the scope of the change, reasoning, justification for the change, ownership and departments involved should be recorded. The organization should have well defined SOP, written procedures for identification, ownership, justification for proposed changes. The documentation involved should clearly define, scope and justification of proposed changes; so that when regulatory auditors evaluate them they should reach to the same conclusion.
Keep away from unapproved changes: Organizations in certain cases execute certain changes which are beyond the scope of change control mechanism. These changes may be harmless “good ideas,” but however they are unauthorized and undocumented. A good example in the regulatory laboratory could be change may occur with respect to modification when “like-for-like” parts are not readily available and a replaced with a nonequivalent part.
Functional SOPs for Change management: Many organization have a large number of SOPs that cross-relate to changes. It is generally considered that if each department has its own change control procedure such as (e.g., processes, analytical methods, facilities, equipment, materials, documents, computer systems) is managed under a separate SOP. Then in such conditions leads to confusion, inconsistencies, overlap, and gaps. Therefore it is highly recommended that they should be centralized SOP for all the change control procedures. This should be controlled, monitored, and executed by Quality Assurance department.
Classification of changes: Organizations monitor the changes by classifying them into minor or major. All the change whether individual or multiple may have additive effect on product quality. Therefore all changes whether minor or major should be evaluated.
Monitoring of Changes: Organizations should verify that change-control was implemented as originally approved, provided the intended output, and has not caused other “undesired” changes. Just like the initiation of change; it should closed in a timely manner. However the timeframe for change can vary on case to case basis dependent on the type of change.
Now that you know this:- hopefully you are in position to answer the Assignment(s)
Does your organization have properly assessed proposed changes completely for the risk involved? Classification of changes done?
Quality Assurance department should consistently access changes to decide their expected impact?
Organizations in certain cases execute certain changes which are beyond the scope of change control mechanism. These changes may be harmless “good ideas,” but however they are unauthorized and undocumented? Please report those cases appropriately to QA department?
Does your organization have centralized SOP control and review system in place? Is it controlled appropriately by change control mechanism?
