Process
Which SOP governs the Change Control process?
SOP PP-780 Change Control System
Characteristics of a Change Owner
Is a qualified, and trained individual who owns the Change Control Record
What form is used to document a change control?
FORM PP-780-F1
CCB stand for
Change Control Board
SISPQ stand for:
Safety, Identity, Strength, Purity, Quality
What is a Change Control?
A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the quality of the products / materials and validated status of facilities, systems, equipment or processes.
Assures that the proposed change is properly _________, _______, and _______ through the appropriate steps for __________.
Documented, Tracked and Routed for Completion
How many assessments forms are needed for a proposed change?
One per each assessor
Who is responsible to organize a CCB Meeting?
Change Owner
When a Risk Assessment must be conducted?
A Risk Assessment must be conducted if a proposed change has the potential to adversely affect the SISPQ of the product.
Mention the five (5) steps during the Change Control Process
Propose, evaluate, approve, implement, review/close
Change Owner is accountable only for the initiation of the change control
False
Accountable for the change from initiation through assessment, evaluation of associated risks to closure.
Advise with respect to potential impact/ risk to quality
Quality Management
When a CCB meeting is required?
To review changes that require high level of scrutiny and cross- functional impact assessment
What is a Risk Assessment?
A systematic process of organizing information to support a risk decision to be made within a Quality Risk Management process.
If consists of the identification of hazard and the analysis and evaluation of risks associated with the exposure of those hazards
Change Control does not apply to:
1.Routine Preventive Maintenance activities
2. Changes that create no real or apparent change in the product or any of its aspects or properties
3. If the change is equivalent (Like for Like)
Who proposed the implementation date for a change control? Based on what?
The Change Owner shall propose the due date based on the proposed implementation activities.
What information must be included in the extension request form?
-Purpose of the extension
- Rationale of the extension
- Status of the change control record and action performed to date
- Any testing requirements
- “Work In-Progress” impact justification and guidelines on actions to minimize or remove risk
What is a CCB?
Cross-functional team constructed , to perform a cross-functional impact assessment of the change
The Risk Assessment may not be required if:
If appropriate actions were identified during the change impact assessment and are completed preceding the implementation of the change
Mention 5 changes that require change control
1. New equipment introduction
2. Construction of new facility
3. Implementation/revision of computerized system
4. New Supplier Vendor
5. Continuous Improvement
Mention five (5) responsibilities of the Quality Unit
1. Assess the change control impact to other areas of quality (e.g. product release , supplier quality)
2. Review assessment provided by impacted functional areas(s)
3. Assures that the identified risk mitigation activities are implemented in parallel with the change
4. Assures that all changes are approved
5. Approves extension to CCRs
6. Assures that CCRs are closed
7. Report Metrics to Management
Important questions that needs to be answered prior the initiation of the change control
Does the intended change affect the form , fit or function of a product or process?
Does it have an impact on Validation, Stability and / or Regulatory; potential impact to a product SISPQ?
Is the change equivalent to an existing change?
CCB review shall determine:
If the listed requirements are appropriate – Scope change may require new CCR or re-assessment of change
If any client needs to be notify
Risks are assess
Impact assessment
The risk-based impact assessment shall evaluate
1. The impact of the change on the availability of the final product
2. The impact of the change to existing equipment, component, facilities, systems, and process
3. The integrity of the product in unaltered as the associated risk is identified
4. The appropriate actions preceding the implementation of the change, e.g. additional testing, (re) qualification, (re) validation, or communication with regulators are identified.
5. Whether or not the need to conduct a formal Risk Assessment
6. Identify “work-in-progress” impact analysis and guidelines on actions to minimize or remove risk: