7 effective ways to implement change control in organization
The purpose of procedure is to define all processes to covered & controlled all kinds of changes affecting the product quality.
The consider requirements of internal management system during defining / considering scope of the processes / procedures that should be covers the all changes in organization that should be in line with assessment, document management and reporting, notifications and controls of each changes with system. Actually the scope is depending on internal system hence the scope should be cover all aspects and possibilities of during and after change effects. Any change within the organization occurred in any processes are measures, verify, reporting and effectively controls are managed by quality assurance team, hence the quality assurance is prime responsible for the preparation and updating of the change control procedure for the execution of the change control processes in accordance with defined, deployed measurements and applicable causes of procedures.
How to apply best practices in processes?
Measurements of issues & assessment
The best practices should be applied in standards operating procedures must apply to all the changes that can impact the outcomes, and effectiveness of the processes on the floor as indicates particular standard operating procedure. Some controls in the process floor is needs in sequences to constantly understand and ensure the endorsed position of internal systems issues to the alteration. Hence each issue should be measured by specific measurement system to easier for classification of each change to recommended levels, the system should have specified categories of changes that effects on product quality that should prioritize accordingly. The measurements of classification can be various methods and types can be recommending, but it’s should be easier for peoples working with it, the complexity and impacts on the processes, categories of change should determine the necessary level of change control.
So, how to determine level of change?
The changes are measured through risk levels, as the causing negative effects on the quality of a product, safety, concentration and identity are defined, hence the risk level are measured according to impacts on the quality of a product with respect to safety. Generally, peoples are defining minor and major changes but it’s all depends on the internal management can define the change as in status, priority, requirements and impacts to easier for peoples to handle control of each change effected.
During the defining the standard operating procedures, the management is also defining scope and applicability of the procedures, situations when the procedures should immediate applicable to identification and control on the situation accordingly. Some basic examples that help to understand when the controls should be effectively implement at appropriate places, like raw materials and purchasing activities, production areas and related internal supporting system, packaging materials and technical corresponding and data management are general requirements or applicability should be managed, the quality testing, methods of testing, measurement, methodology, specifications, quality documentation, control related procedures, validations, equipment and its testing methods are major applicable subjects. See below table helps to understand how to manage changes, setup priority and deployment needs of changes. (Below examples are education purpose – Case study by: Inpaspages.com)
|Major Change (High Risk)||Minor Change (Low Risk)|
|>> Change of the producer / manufacturer of raw materials – Approvals, implementation / vendor|
|>> Change of the cleaning personnel not involved in Manufacturing activities, Raw materials Handling & Storage, Packaging or any production (R.M.Transfer)|
|>> Technical details – Product / Process, upgrade / downgrade, specification, Parameters change etc.||>> Raw materials / Technical / Packaging document font change, dragging any field, report view change etc.|
Corresponding media change, Technical sheet implementation (minor)
|>> Raw material testing method, measurements, testing method change, testing equipment changes||>> Equipment / Device installation, removing which is now directly impacting on Raw Materials storage and packaging processes and quality.|
|>> Storage – Storage media change, Storage location change, Storage system, Rack, Method, Environment change|
|>> Raw material Packing – Packing & packaging change, Material change,|
Packaging material specification change
Change Proposal announcement
The management should deploy the system and apply at in the internal management system that each activity, processes should be documented and estimated before any change made, or impact which such change made on it and each activities, processes and documents should be approved by authority. The management / internal management system should handle the standard operating procedures that indicate the change controls and its related document like change control sheet, change control form and results documents which shall be filled in and authorized by concern. The responsible department must prepared change control record to communicate each change effecting existing system. See the example format of Change control form:
The management should have prepared standard operating procedures that describe the documentation and guidelines for completion the change control form. The change control form must be filled by responsible personnel and approved by authority for relevant department to submit quality assurance department within the time limit, and in the change control form all the details should be properly indicated with all the document of the proposed change should be added to change control form.
Structure of change control documents
Documentation management system should have covered the requirements of change controls related documentation, each document should be controlled and unique identification number established, the numbering, formatting and structure of documentation should be verified and approved by authority, and also the quality assurance department approvals, reviews and periodically verification conducted.
Monitoring of change offers
Any change offer from various department are receiving and implementation process is conducted through responsible department, the quality assurance department is responsible for the recording of each document related to change control, hence the monitoring and tracking activities, documents and related processes are managed accordingly. Each document and its related activities are handled by quality assurance team to extract the information to successfully implementation.
Assessment of change offers
All the change offers are shall be reviewed by quality assurance department, responsible personal are collecting information and reviews specialist in line with change assessment requirement. Generally, experts are review the change proposal for its assessment phases are verify to reviews the possibilities and risk assessment, determination of process to be performed, project closing target date, change procedures and related documentation, approvals and notification of activities with performance and closing of process / procedure approvals.
In the change control and assessment offer, most important part is the risk management that is risk assessment, it is assed whether change offer related to best practice for the risk management, hence the in change proposal all the risk factors, levels and controls should be covered in line with internal floor requirements. Determination of the risk impact and probability is important to establish good manufacturing practice, hence each risk should be categorized as its risk level and potentiality, the change to be direct impact on the processes and safety should be considered as critical risk that should be setup on priority, hence the minor and medium type of risk should be properly controlled and reduction by frequent actions.
Each change offer should be complied in deadline period, quality assurance team is responsible for define the deadline for each change, change which are not completed in the period that should be conducted on priority.
Succeeding of change control
The quality assurance is responsible for the documentation management related to change controls hence all the archived documents, records and related materials are managed and recorded in the standard formats. The recorded all the activities and processes are managed for monitoring.
Change control documentation, processes and results are conducted for the periodical reviews to ensure the direction of the processes, change proposals are assessed and reported in the report accordingly to its topics, risk assessment results, finalization of change offers.