How to Make a Change Control in 6 Steps.

In this article, you will learn how to make a change control in 6 steps.  Sometimes equipment and process changes are more complicated than others. But, it is important to keep it simple and avoid change controls of 60 steps.

The change control process is performed following a sequence of steps starting with the submission of a change request.

The following six (6) steps describe how to make a change control request:

1. Documenting the change request:
   When the request is initiated, that request is categorized and recorded, along with informal assessments of the importance of that change and the difficulty of implementing it.
2. Formal assessment:
   The justification for the change and risks and benefits of making/not making the change is evaluated. If the change request is accepted, a team will be assigned. If the change request is rejected, that fact is documented and communicated to the requestor.
3. Planning:
   The team responsible for the change creates a detailed plan for its design and implementation, as well as a plan for rolling back the change should it be deemed unsuccessful.
4. Designing and testing:
   The team designs the steps and instructions to implement the change and tests it. If the change is deemed successful, the team requests approval and a date for implementation.
5. Implementation and review:
   The team implements the change and stakeholders review the change.
6. Final assessment:
   If the team is satisfied that the change was implemented satisfactorily, the change request is closed. If the team is not satisfied, the project is reassessed and steps may be repeated.

HOW TO PURCHASE A CHANGE CONTROL FORM AND TEMPLATE PROCEDURE?

A change control form and procedure template are available from the CIQA Store.

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CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Change Control or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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Three (3) Options on how to make a Change Control Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the Change Control Management procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill and adapt to your specific needs.

Silver Option. We Can Bring You a Formal Training on how to make a Change Control?

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

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REFERENCES:

For more information about Change Control, refer to:

STATUTORY AND REGULATORY REQUIREMENTS

The Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations describes the importance of this topic in the following reference: httpss://www.fda.gov/media/71023/download

It is a systematic approach to proposing, evaluating, approving, implementing, and reviewing changes (ICH Q10)

For more information about Change Control, refer to:

httpss://www.fda.gov/media/118202/download

httpss://www.fda.gov/media/85273/download

QS Regulation and Guidance • Quality System Regulation and Preamble

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm

Inspection Guide – Pages 8, 15, 21, 22 and 23

httpss://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm

Guide to Inspections of Quality Systems [Quality System Inspection Technique (QSIT)]

www.fda.gov/iceci/inspections/inspectionguides/ucm074883.htm