Department | Quality Management | Document no | QMS-120 | ||
Title | Quality Concern Investigation Process | ||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
Document Owner
Quality Assurance Manager
Affected Parties
All manufacturing personnel
Purpose
To define the procedures to be followed when conducting Investigations and to raise and assess Deviation Report when an Investigation or Incident Investigation occurs.
This procedure is to be used in conjunction with SOP QMS-035, which covers the approval and follow-up activities associated with a Deviation Report.
Scope
This procedure applies to Quality Assurance Personnel, Management Personnel and Production Staff who are involved in Investigation and Incident Investigations.
Definition
DR | Deviation Report is a documentation system for recording, investigation and analysis of material and processes that do not comply with company requirements. |
Corrective Action | Corrective actions are actions taken to fix the current problem and can be rapidly implemented. |
Preventive Action | Preventive actions are actions taken whose implementation should eliminate the possibility of the future recurrence of the issue/problem. |
Related Documents
Form-450 | Deviation Report Form |
Form-455 | Incident or Investigation Report Form |
QMS-020 | Documentation Rule for GMP Documents |
QMS-035 | Deviation Report System |
QMS-065 | Rework Procedure |
QMS-080 | Audits |
QMS-055 | Product Complaint Procedure |
EHS Statement
There is no EHS impact.
Procedure
1. Batch Record Comments
1.1. Definition
Batch record comment is a minor event, which is something that is expected to occur, is usually isolated to a single batch, the cause is known with certainty, no follow-up action is required and is non-recurring within a short period of time. For example line stoppages at certain time, etc.
1.2. Timelines
Batch Record comments must be documented immediately when event occurs.
1.3. Investigation Steps
Define the problem, be specific about who, what, when, where, how and why
1.4. Reporting
1.4.1. Batch Record Comments must be documented within the comments section of the Manufacturing Instruction Sheet.
1.4.2. Batch Record Comments are reviewed by a Quality Assurance Staff at the time of batch record review for batch release.
2. Deviation Report (DR)
2.1. Definition
Deviation Report is a documentation system for recording, investigating and analyzing of materials and processes that do not comply with in-house requirements and are raised for events that require investigation. DRs are relatively minor, usually isolated events or deviations from agreed/ approved procedures or processes that usually result in rapid implementation of corrective action and are unlikely to have any impact on product quality, safety or efficacy. DRs are also raised for serious and standard audit observations.
2.2. Timelines
2.2.1. A Deviation Report (DR) should be documented within a maximum of 2 working days from the event being observed and submitted to QA Management Review.
2.2.2. A Deviation Report (DR) should be analyzed, appropriate follow-up actions defined. Management response tasks should be completed within 5 working days, if possible.
2.2.3. Any follow-up corrective or preventive actions are to be completed within agreed timeframes.
2.3. Investigation Steps
Define the problem, be specific about who, what, when, where, how and why.
2.4. Reporting
Comments, Corrective & Preventive Actions (CAPA) must be documented within the management tasks and follow up tasks as appropriate. . A Deviation Report Form (Form-450) needs to be completed after an investigation by the Area Manager, where the deviation occurred, and QA management.
3. Cross Functional Investigations (CFI)
In addition to any corrective actions already taken, a Cross Functional Investigation, (which applies to Investigations, Repeat Investigations, Incidents and Repeat Incidents) is required in order to identify the root cause(s) and may require the proposal and implementation of suitable (long-term) preventive actions.
3.1. Definitions
3.1.1. An Investigation is a DR, which has been identified as requiring more in depth investigation with the involvement of different functional departments. It is a relatively minor, isolated event or deviation from agreed/ approved procedures or processes that is unlikely to have an impact on product quality, safety or efficacy but requires the implementation of corrective and preventive action plans. This also includes the rejection of partial batches in-process.
3.1.2. A Repeat Investigation is an investigation event, which has occurred more than once within 12 months with the same root cause on the same team or an investigation event that occurred more than three times within 12 months with the same root cause across all teams.
3.1.3. An Incident is a DR, which has been identified as an event or deviation from agreed/approved procedures or processes that has an actual or potential adverse effect on product quality, safety or efficacy. This also may arise as a result of three or more repeat investigations or a critical audit observation, and also includes the rejection of finished product batches.
3.1.4. A Repeat Incident is an incident investigation event, which has occurred more than once within 12 months with the same root cause on the same team or an incident investigation event that occurred more than two times within 12 months with the same root cause across all teams.
3.2. Timelines
3.2.1. A Deviation Report Form (Form-450) should be documented within a maximum of 2 working days from the event being observed and submitted to QA Management team for Review.
3.2.2. QA Management Rep. should organize an Investigation Meeting with all relevant parties within 5 working days of the generation of the Report. Management response tasks and Follow up tasks are raised for the appropriate persons. Management response tasks are to be completed by the Area Manager where the deviation occurred and QA management after the investigation will be completed.
3.2.3. A Draft Incident or Investigation Report Form (Form-455) is raised after the meeting. Meeting minutes are documented in the form and circulated to all present for comment as soon as possible and responded to within 2 working days of receipt.
3.2.4. An electronic copy of the completed Investigation report is circulated to key members of the Management team upon completion.
3.2.5. The Investigation Report with meeting minutes, supporting documentation and agreed corrective / preventive actions assigned is targeted for completion within 30 working days from the time DR was raised, or for more complex investigations, 10 days after the close-out meeting of an on-going investigation.
3.2.6. As the investigation report is finalized, QA management Rep. to circulate the DR, which was raised initially, to complete the management response tasks.
3.2.7. In the event an Investigation is on-going, and takes longer than 30 working days to complete, minutes of on-going meetings, which include justification for production and additional actions taken should be circulated to management and maintained with the final Investigation report.
The hard copy file number (see section 3.4.4) of the signed Investigation Report and supporting documentation is held in the QA office for the current year, and is assigned a investigation when archived.
3.2.8. Follow up tasks in the DR should be assigned to a QA member, for 3 months to check on completeness of implementation, if preventive actions are not completed at the time of closeout of Investigation. In the event that the preventive actions take longer than 3 months to complete additional follow-up task may need to be assigned to track the preventive action to completion.
3.2.9. Upon completion of all management response tasks and preventive action follow up tasks in the DR, hardcopy deviation report is printed and filed with the Investigation Report.
3.3. Investigation Steps
3.3.1. It is the responsibility of the department, where the problem originated, to involve in the investigation in consultation with the Quality Assurance Department to ensure adequacy of the investigation.
3.3.2. Define the problem in detail. Include who, what, when, where and how. Briefly describe why the event is a problem. This should be a statement of facts.
3.3.3. Identify the probable causes. These could be raw materials, processing/operations error or problem, equipment or instrument problems, adverse environmental conditions, supporting utilities, and/or testing, analytical errors.
3.3.4. Investigate each probable cause. Prepare a list of questions and records needed for review. Assign and delegate the gathering of information.
3.3.5. Analyze the information and identify the actual or suspect cause(s). Analysis of data must be objective and logical.
3.3.6. Determine the extent of the problem. Is this an isolated occurrence limited to one batch or is this a recurring or potentially system related problem. Evaluate the effects on other processes, products and batches.
3.3.7. Propose actions and recommendations for the affected batch(s). Evaluate the following aspects of the batch:
Quality Aspects such as product safety and integrity, product purity and efficacy, product stability, customer perception and potential complaints.
Regulatory Aspects such as deviations from product registration commitments.
Compliance Aspects such as violation of cGMP, or deviations from revalidation / re-qualification requirements.
3.3.8. Develop corrective/preventive actions (CAPA); determine need for new data.
Develop corrective actions to support affected batch or batches. Corrective actions relating to batch disposition are documented in the Management Response Tasks of the DR (i.e. confirm rejection of the batch).
Develop preventive actions to avoid recurrence.
Corrective and preventive actions must be monitored to completion.
All other Corrective actions and Preventive actions are documented in the follow up tasks of the DR and tracked to completion as per section 3.2.7 of this SOP.
3.3.9. Document and approve.
3.3.10. Track actions to completion.
3.3.11. Trend causes – add all the investigation outcomes including the root cause/s, corrective and preventive actions on a spreadsheet for the current year to facilitate in trending the repetitive issues.
3.4. Reporting
3.4.1. The report must be documented on Incident/Investigation Report Form Form-455.
3.4.2. The report must be organized, detailed, include all attachments and be written for the outside reader.
3.4.3. The report should include the following:
a. Data in tables or traceability matrix where applicable. It should avoid checklist approach.
b. A brief description of process/testing and identify materials used in batch.
c. Problem description, problem discovery (who, what, when, where, why, how) and include test specifications for each pertinent test result.
d. Documentation of each probable cause.
e. Documentation of the investigation findings relative to each probable cause.
f. Evaluation of each probable cause.
g. Elaboration on actual or suspect causes(s).
h. Documentation of the logic used, cite the data being used.
i. Evaluation and documentation of whether other batches are potentially involved.
j. Provision of the rationale for investigation conclusions.
k. Corrective and preventive actions; short term, long term, global
l. Impact on batch(s) disposition.
3.4.4. The incident or investigations are given a number as reference before filing.
Investigations are referenced as YY-INV-XXX where YY are the last 2 digits of the year in which the investigation took place, INV stands for investigation and XXX is the three digit number unique for the report, assigned sequentially up to the end of the year. i.e. 05-INV-001.
Incidents are referenced as YY-INI-XXX where YY are the last 2 digits of the year in which the investigation for incident took place, INI stands for incident and XXX is the three digit number unique for the report, assigned sequentially up to the end of the year. i.e. 05-INI-001.
All Deviation Report numbers are cross referenced in the investigation or incident report for future traceability.
3.4.5. The report is reviewed and approved by the Production Manager and QA Representative. Signed copy of form Form-455 should be returned to QA within 30 days from issue of report. The Production Manager and QA Representative holds a meeting on a monthly basis, if required, to review Investigation / Incident Report (FM-0686) and supporting documentation for completeness and close the Investigation by signing the reports.
4. Product Complaints Investigation
In the event a complaint received is deemed of a nature that requires extensive investigation, it is raised to an Investigation, a DR is raised and a Investigation meeting is organized and follows the process as described in Section 3.
5. Product Recall Procedure and Investigation
In the event a complaint or an investigation of a Quality Concerns leads to the determination that a Product Recall is necessary, the investigation shall be escalated to a Product Recall.
Summary of Changes
Version # | Revision History |
QMS-120 | New |
Appendix 1: Related Forms
Form 450: Deviation Report Form
DR Number: | DRX-YYYY | Priority |
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Author(Reported by) | Date Reported | Area/Team Responsible | |||||||||
DR Type: (fill in applicable information) | |||||||||||
DR5 Customer Complaint Deviation | |||||||||||
Customer No.: | Delivery Doc. No.: | ||||||||||
Sales Order No.: | Customer Material No.: | ||||||||||
Sold to Party No: | |||||||||||
DR8 Material Complaint Deviation | |||||||||||
Vendor No. or Vendor Name: | Purchasing Doc. Number: | ||||||||||
Material Doc. No.: | Vendors Material No.: | ||||||||||
DR1 Process / Procedural Deviation | |||||||||||
Product code: | Equipment No. | ||||||||||
MI Sheet No.: | Batch (BPN): | ||||||||||
DR4 Audit Deviation | |||||||||||
Audit Ref. No. | Audit Type | ||||||||||
DR2 EHS Deviation | |||||||||||
Deviation Title | |||||||||||
Description (Must be filled in for all deviation types) | |||||||||||
Management Response Tasks | |||||||||||
1. Area Manager Response Tasks(Describe the facts, corrective actions taken. If a preventative action is necessary list in the Follow up tasks. Sent the report to Second management response tasks) | |||||||||||
Name: | Sign: | Date: | |||||||||
2. Second Management Response Tasks(Review area manger’s response and justify efficacy of corrective actions taken. If a preventative action is necessary list in the Follow up tasks. Sent the report to QA management response tasks) | |||||||||||
3. QA Management Response TasksQA Manager to evaluate the deviation and assess the potential impact to the product quality, validation and regulatory requirement. Asses efficacy of the actions taken. Approve the DR) | |||||||||||
Name: | Sign: | Date: | |||||||||
Follow up Tasks | |||||||||||
Task 1: | |||||||||||
Assigned To | Planned finished date | ||||||||||
Confirm Task 1 completed: | Sign: | Date: | |||||||||
Task 2: | |||||||||||
Assigned To | Planned finished date | ||||||||||
Confirm Task 2 completed: | Sign: | Date: | |||||||||
QA manager Approval Task | |||||||||||
Confirm follow up tasks completed: | Sign: | Date: | |||||||||
List all follow up tasks in the QA Metrics Sheet. Place the completed report into completed DR file. If a DR is process related affecting any BPN, attach one completed copy with the batch documents. | |||||||||||
Investigation Type
This should list the type of investigation
(eg. Process Failure, Operator Error, etc.).
Executive Summary
The executive summary should contain a brief description of the event, root cause found during the investigation and a final summary on product disposition.
Name (Position) | Signature | Date |
Prepared by: | ||
Checked by: | ||
Authorized by: | ||
Approved by: |
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- Event
Description of event and details to be added here.
Process Line(s), Product Name(s), Product Code(s) and Batch No.(s) to be added here.
Initial Scope of the investigation and any immediate action/segregation/blocking of stock for sale should be listed here.
2. Batch Chronology
This table is an example of events that may need to be documented in a batch investigation chronology. Table can be customized (or even omitted) to fit the sequence of events in an investigation.
Date(dd/mm/yyyy) | Time(24 hrs) | Description |
dd/mm/yyyy | 00:00 | Example – Batch planned / scheduled |
dd/mm/yyyy | 00:00 | Example – Batch commenced filling |
00:30 | Example – Shipper No at time of event | |
05:00 | Example – Line Clearance performed after event | |
06:00 | Example – DR raised at this point |
3. Suspect Causes and Rationales
No. | Cause Description | Primary / Contributing / Unlikely |
3.1 | Enter suspect cause here | Choose one type from above |
Rationale: This is where you enter your rationale as to why a suspect cause is likely to be correct or why you have discounted this particular cause | ||
3.2 | Enter suspect cause here | Primary / Contributing / Unlikely |
Rationale: This is where you enter your rationale as to why a suspect cause is likely to be correct or why you have discounted this particular cause | ||
3.3 | Enter suspect cause here | Primary / Contributing / Unlikely |
Rationale: This is where you enter your rationale as to why a suspect cause is likely to be correct or why you have discounted this particular cause | ||
4. Corrective and Preventive actions to be taken
State corrective and preventive actions, which need to be taken and the reasoning behind decisions made.
5. Risk Analysis – Potential impact on other processes
Here is where you outline whether this event could have an impact on any other equipment or processes and your rational as to why you have made this conclusion.
You should also explore whether this is a repeat event or the first time this has occurred.
6. Product Disposition
6.1. Product made prior to the event
Here is where you outline the risk assessment and impact to product made prior to the event and rationale as to why it is either acceptable or not.
6.2. Product made during the event
Here is where you outline the risk assessment and impact to product made during the event and rationale as to why it is either acceptable or not.
6.3. Product made after the event
Here is where you outline the risk assessment and impact to product made after the event and rationale as to why it is either acceptable or not.
7. Summary
Here is where you write your conclusion to the investigation, you must summaries the overall root cause found during the investigation, the impact on this batch and any other batches and the overall batch disposition.
8. Root Cause
State the root cause or suspect cause if root cause was not determined.
8.1. Repeat Event
State if a similar event occurred in the last 12 months and DR reference.
8.2. Batch Disposition
State final batch disposition and reasoning behind the decision.
8.3. Impact on other batches / processes
State if other batches/processes are impacted and reasoning behind the decision.
9. List of Attachments
Brief list of attachments to be added here
9.1. Attachment – Summary of Investigation Tasks
Task Description | Responsible | DateDue | Date Completed |
Enter tasks here |
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9.2. Attachment – Summary of Corrective Actions Tasks
Task Description | Responsible | DateDue | Date Completed |
Enter tasks here |
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9.3. Attachment – Summary of Preventative Actions Tasks
Task Description | Responsible | DateDue | Date Completed |
Enter tasks here |
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Note: Batch release may occur prior to the preventative items being completed
Attachment – Investigation meeting minutes
9.4. Meeting Minutes
If there are multiple meetings or discussions these should be listed on this page
9.5. Attachment – Supporting batch documentation
9.6. Attachment – Deviation Report/s
If there are multiple DR associated with this event then these should be listed on this page.
9.7. Attachment – Supporting Batch Documentation / Log Books
If there are exerts from the batch documentation or copies of log book pages associated with this event then these should be listed on this page.
9.8. Attachment – Supporting Facilities Data
List copies of in-process checks printed from the production lines.
9.9. Attachment – Supporting Analytical Data
Copies of Analytical data associated with this event.
9.10. Attachment – Validation Data
Copies of Validation data associated with this event.
Attachment – Evidence of actions completed
9.11. Attachment – Employee Awareness Forms
Employees counselled as a result of this event should sign a form to say that they understand the nature of their involvement and be filed behind this attachment.
9.12. Attachment – SOP Updates
Evidence of critical updates to SOPs to be filed behind this attachment.
9.13. Attachment – Training / Assessment Updates
Evidence of critical updates to training and assessment be filed behind this attachment.