Wikipedia (other information sources are available, and recommended) states;
Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without forethought and that anyone is introducing faults into the system or undoing changes made by other users of software. The goals of a change control procedure usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilisation of the resources involved in implementing change.
So what does this mean… in plain English?
It can be broken down to the “6 Ps” – Prior Proper Planning Prevents Poor Performance.
Change control is barely mentioned within Good Distribution Practice 2013/C 343/01
Chapter 1, Quality Management, Subsection 1.2 states “A change control system should be in place. This system should incorporate quality risk management principles, and be proportionate and effective.”
This doesn’t help you understand or deliver a good change control, and to many it’s just another line of text in the regulations.
The MHRA “Green Guide” – Rules and Guidance for Pharmaceutical Distributors 2017, pages 135-136 covers change control;
Change control is a formal process whereby changes to a process are identified, planned and introduced in a controlled way.
A typical change control process may consist of several stages:
– Submission of a documented change control request to management.
– Consideration and evaluation of the request by management. This evaluation should consider if the change poses any risk to public health or if there could be any impacts on other processes and procedures. Actions identified at this stage should be resolved prior to approval.
– Implementation of the change. This is a live process and unforeseen events during implementation should be subject to further assessment of their risk.
– Review of effectiveness. After an appropriate period an objective review of the effectiveness of the change should take place. This should consider both successes as well as any problems that have arisen, with any lessons learnt being used to improve the process for future changes.
Much better! However, there are still some issues if you haven’t carried out a change control before… such as what is an appropriate period?
We would return to our old friend, the risk assessment. Depending on the level of risk associated with the change, it will vary. The higher the risk, the sooner the assessment should be.
You will also need to remember to re-assess, which again will depend on risk as well as the findings from the initial assessment.
10 Mar 2020
2 Apr 2019
2 Apr 2019
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