Deviation
How many extension requests can be made for a deviation?
Only one (1) extension may be permitted
A second extension can be applied only if the due date of the first extension cannot be met due to external factors (customer request, customer approval).
This deviation needs to be evaluated by a member of the Site Quality Leadership Team, who will then review and approve the request.
What are the mandatory assessments that must be completed before the CR is approved for implementation?
The following assessments are mandatory:
Regulatory assessment
Safety assessment
Validation Assessment
Data Integrity Assessment
For the regulatory and HSE assessment as far as it is evident that the change has no effect on any of these two areas, the evaluation can be carried out by the change manager or QA. Otherwise, these assessments should be carried out by the specific specialist functions.
For Validation assessment the evaluation must be performed and documented in the “Validation Assessment Comments” filed by the Validation specialist and if required controlled and supplemented by QA validation.
For DI assessment, if the record was selected as Data integrity relevant (Yes), the impact need to be recorded by the DI SME in the “Other Assessments” field.
Note; If an additional assessments need a child task can be opened “Change assessment”
What is the timeline for defining the CAPA Action Plan?
5 working days from initiation of the CAPA.
When is it necessary to check the effectiveness of CAPAs for DR and CR?
• CAPA: Effectiveness checks must be performed for CAPAs resulting from major/critical deviations or major/critical audit/inspection observations. Effectiveness checks may also be included as needed for other CAPAs (all CAPAs for medical device products require effectiveness checks).
• CR: The need for an effectiveness check of a change has to be evaluated for all changes of any change category.
When a customer complaint is received, where is it documented and with what timelines?
Customer complaints are always handled as deviations in TrackWise.
TW deviation for customer complaint must be initiated within one business day from Complaint reception
What are the timelines for opening and closing a Deviation?
Opening:
Within two business days after detection of the event
Within one business day from detection of the event for of post-release and/or critical deviations with potential impact on the distributed product
Closure:
30 calendar days (45 days if customer approval required)
What is the main difference between handling temporary and permanent changes in the process flow?
Temporary changes: The process flow for temporary and permanent changes is identical. However, the mandatory opening of a post-change task to ensure the restoration of the original controlled status is necessary here.
What does the acronym SMART stand for?
• S – Specific
• M – Measurable
• A – Accountable
• R – Reasonable
• T – Timely
What is the purpose of an effectiveness check in the CAPA process?
To verify if implemented CAPA has provided expected results by analyzing the relevant data or a check that is performed after a longer period of time to make sure that no unintended effects have resulted from the change
By when and how should the acknowledgment of the complaint be documented?
Within one (1) business day
The acknowledgment needs to be documented in the “Customer Approval Progress” field in TW.
Which are the preferred methodologies used to perform an RCA for deviations?
• 5 Whys
• Ishikawa Diagram (Fishbone)
• Causal Branching (mapping)
• Fault Tree Analysis
• Event and Causal Factor Charting
• Defence Analysis
What is the difference between pre and post tasks?
Pre-change task: The completion of a pre-change task is required before the implementation of a change. Pre-change tasks describe activities that should be carried out or initiated before the implementation of the change. These are for example the preparation of validation protocols, update and approval of MBRs, QC plans, stability protocols etc.
Post-change task: The completion of the task is required after the implementation of a change. Post-change tasks describe activities that are to be carried out or initiated after a change has been implemented. These are for example the preparation of a validation report, putting samples on stability, carrying out verification runs etc. The completion of the task is necessary for the timely finalisation of a change.
What are the possible types of strength of CAPA and their level ?
Elimination: 4
Prevention: 3
Detection and Recovery: 2
Duplication: 1
Retraining/Awareness: 0.5
What is the general rule for setting the date for the effectiveness check?
As general rule the date for the effectiveness check should be set ca. six months after the implementation date of the CAPA. This date can vary depending on the CAPA (for example if the CAPA is campaign/ product specific and the next campaign is earlier or later). For general CAPAs it is recommended to stick to the general ca. six months.
What are a Major and Critical Complaints?
Major:
Product quality complaints – concerns physical, chemical and/ or biological properties of the product. No significant hazard to health is expected.
Critical:
Medical/ adverse event complaints - could cause illness or incorrect treatment but is not Potentially life threatening or could cause serious risk to health
When the deviation must be investigated?
All Deviations with a critical and major Quality Impact Rating must be investigated
All Deviations with high Risk Category
Deviation concern Validation activities
For minor DR with direct cause not known or when DRB decides that investigation is needed
What is the role of the change manager in the pre-change process before QA review?
The change manager must raise a final pre-change task for QA to review all pre-change tasks. This is carried out to ensure: an adequate completion of pre-change tasks and to provide QA authorization for GMP/routine use.
When is the CAPA process used? And when should the CAPA process not be used?
The CAPA process is used when needed to document the corrective or preventive actions identified through analysis of the various sources of quality data:
in an investigation (deviation investigation or stand-alone investigation)
to resolve a finding by a regulatory authority
to resolve a finding by an internal or external audit
CAPA process should not be used for activities such as assessment, improvement, monitoring, evaluation, investigation, and optimization that do not address the root cause of a deviation; in this case it is recommended to use Stand-Alone Investigation
How and when is the Effectiveness Check record created for DR and CR?
The Effectiveness check record:
DR: Is automatically created by the system as a child record from CAPA, if the “Effectiveness Check required” field was selected Yes in the relative CAPA
CR: Can be opened by QA as a child record of the Change Request once the CR is in the status “Ready for Closure”
What are the timelines for Complaint investigation?
Low: 30 days investigation – 45 days for closure after day 0
Medium: 15 days investigation – 30 days for closure after day 0
Critical: escalation I 1 business day - investigation –15 days for closure after day 0
What is the timeframe for assessing the impact of critical and major deviations? And when does Regulatory Affairs need to be consulted?
For Critical and Major Deviations, an impact on the affected batch as well as other batches and processes, on regulatory dossiers and an impact to batches other than the one directly impacted by the deviation must be assessed within the time frame stipulated by responsible authorities, or within a maximum of 5 working days after the initiation of the deviation.
Regulatory Affairs must be consulted to determine regulatory impact either as part of the DRB process or within the five business day timeframe noted above. This consultation and any decisions must be documented in the deviation record
What are all the different change request statuses in TW (12 steps, list minimum 8)?
1. Opened
2. Record Initiated
3. In Review
4. In QA Review
5. In Approval
6. Pending QA Approval
7. (Pending Customer Approval)
8. Approved for Pre-change Tasks
9. Pending Post-Change Tasks
10. Change Evaluation
11. Ready for Closure
12. Closed
What are the timelines for completing the CAPA? And what factors should be considered when setting the due date?
The standard for completion of the CAPA is 30 days for a routine CAPA and 90 days for a longer-term CAPA.
However, the due date should be reasonable considering all defined actions and should take into account the following points:
• Production schedule, if the underlying problem is product specific (when is the next production)
• Risk of reoccurrence
• Risk of observation (regulatory or customer)
• Lead time for implementation
What steps should be taken if a CAPA fails to achieve the expected results?
If executed CAPA did not provide expected results, a new investigation needs to be performed to review root cause(s), contributing factors and/or defined CAPAs in the parent record. The need of such a new investigation to determine root cause of the failure and appropriateness of implemented CAPA and the decision must be documented in the Effectiveness Check record. Traceability among all these records must be ensured by referencing the first record in the new one.
What are the timelines for Swissmedic notification for Complaint when needed?
• 24 hours Class I
• 3 Calendar Days Class II
• 5 Calendar Days Illegal trading
• 15 Calendar Days Class III