Department | Quality Management | Document no | QMS-130 | ||
Title | Cross Functional Investigation | ||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
DOCUMENT OWNER
Technical/Quality Manager
PURPOSE
This procedure describes the guidelines for initiating, communicating, conducting and documenting Cross-Functional Investigations (CFI) related to process, system, product, material, facility and laboratory deviations. A Cross–Functional Investigation is an extended investigation conducted in order to identify a Root Cause.
SCOPE
The Scope of this SOP covers Cross Functional Investigations also known as extended investigations. CFI’s are raised when a deviation occurs or there is a complaint trend, Annual Product Review trend or trend in any other Quality aspect identified by a Quality System.
This SOP does not cover Continuous Improvement Projects/Investigations that have been identified and are not related to a Deviation or any other Quality Failure or Trend.
A CFI, also known as an extended investigation is raised for unexplained deviations (i.e. defects that are outside normal operating parameters or the failure of a drug product to meet any of it’s specifications), where the assignable cause is not readily apparent.
RESPONSIBILITY
4.1 Business Rules
4.1.1 CFI’s are raised when the following occur:
The cause of the deviation cannot be determined.
There is a probable cause based on available evidence, but the cause is not confirmed.
A deviation demonstrates repeated trends, or when there are repeated trends indicated by other quality systems, for e.g. Complaints, Annual Products Reviews.
4.1.2 The CFI Investigation process should follow the Right First Time, Cause – Effect, DMAIC process, which is described in the Six Sigma DMAIC process chart. (Please see the following reference for more on DMAIC process http://www.vrds.com/sixsigma/dmaic.htm)
4.1.3 Summary and recommendations for all CFIs are presented at the site meeting.
4.2 Responsibility
4.2.1 Responsibility of Quality Assurance Manager
The Quality Assurance Manager or Delegate determines the need for a CFI.
4.2.1.1 The Interim report is approved by the Quality Assurance Manager or delegate.
4.2.1.2 To track progress of the CFI report actions and recommendations and request interim reports where required.
4.2.1.3 To compile Progress reports of outstanding CFI reports, outstanding Action items and Recommendations in a Monthly Report which is sent to management and responsible persons.
4.2.2 Responsibility of CFI Team Leader and CFI Team
4.2.2.1 To carry out the CFI process using appropriate investigation tool and follow the DMAIC process.
4.2.2.2 To attend all CFI meetings and carry out all actions assigned to each member.
4.2.3 Responsibility of quality review team
4.2.3.1 To review and approve the final CFI report.
4.2.3.2 To review and assess CFI’s that are greater than 90 days.
4.2.3.3 To review and assess CFI’s where an assignable cause cannot be determined after investigation is complete.
4.2.3.4 To review the progress of the closure of CFI reports, actions and recommendations.
PROCEDURE
5.1 Quality Assurance and Compliance Manager or Delegate is responsible for recommending the initiation of a CFI when the root cause of a deviation cannot be determined, or when there is repeated trends in deviations, Customer Complaints, Annual Product Review Systems or any other Quality System.
5.2 The Quality Assurance Manager or Delegate assigns a CFI Team Leader to progress the investigation.
5.3 Use the Cause – Effect and DMAIC Process Chart to investigate. The DMAIC process gathers facts from interviewing colleagues, batch record review, complaint files, retain samples, procedures, stability data, trends in deviations or CFI’s, Product Change Control, Annual Product reviews, etc. as appropriate. The investigation is extended to other batches of the same product or other products that may be associated with the specific failure or incident as required. Facts are gathered from other sites, and or outside vendors, if required.
5.4 Use the Cause – Effect Investigation Report to document the CFI process.
5.5 When potential root causes have been identified, ensure the following are addressed:
5.5.1 Impact on Product Quality, Qualifications or Validations of equipment, Systems, Processes, Analytical Methods
5.5.2 Ask questions such as: How does the problem item compare to items without the particular deviation? Does the difference in the problem item suggest a change may have occurred? How many units have the problem?
5.5.3 Other lots or products that might have been affected, are the raw materials from the same lot affected, the use of common pieces of equipment needs to be identified and considered for a similar situation.
5.5.4 If the results of a product quality impact assessment pertain to any product in the field, the members of the site quality review team need to be notified immediately.
5.6 An Investigation Report is then written, identifying the Summary, Investigation results, Impact on Product Quality, Corrective Actions, Conclusion, Recommendation and Disposition.
5.7 As part of the Investigation Report, develop and document all Corrective Actions and Preventative Actions that were taken to solve the immediate problem and measures taken to prevent recurrence. The Preventative Actions taken should attempt to assure a permanent solution to solving the issue, not a temporary fix. If the Preventative Actions taken cannot be implemented prior to completion of the CFI, document the Preventative Action, person responsible and the time line for completion in the Report.
5.8 The Investigation Report conclusion details a summary of the Investigation Results, Potential root causes, Corrective Actions carried out, Preventative Actions and/or Recommendations in relation to the root causes identified, and Disposition of the batch(es). A Risk Assessment may be used to justify the disposition.
5.9 If after the CFI investigation has been completed, the root causes cannot be identified, the CFI will be brought to the attention of the site quality review team where it will reviewed and further actions assessed.