1. Following are some examples of deviations raised from different functional areas of business:
2. Production Deviation - usually raised during the manufacture of a batch production.
3. EHS Deviation - raised due to an environmental, health and safety hazards.
4. Quality Improvement Deviation - may be raised if a potential weakness has been identified and the implementation will require project approval.
5. Audit Deviation - raised to flag non-conformance identified during internal, external, supplier or corporate audits.
6. Customer Service Deviation - raised to track implementation measures related to customer complaints.
7. Technical Deviation - can be raised for validation discrepancies. For example: changes in Manufacturing Instruction.
8. Material Complaint - raised to document any issues with regards to non-conforming, superseded or obsolete raw materials/components, packaging or imported finished goods.
9. System Routing Deviation - raised to track changes made to Bill of materials as a result of an Artwork change.
All batch production deviations (planned or unintended) covering all manufacturing facilities, equipments, operations, distribution, procedures, systems and record keeping must be reported and investigated for corrective and preventative action.
Different Levels of Deviation Risks:
For the ease of assessing risk any deviation can be classified into one of the three levels 1, 2 & 3 based on the magnitude and seriousness of a deviation.
Level 1: Critical Deviation
Deviation from Company Standards and/or current regulatory expectations that provide immediate and significant risk to product quality, patient safety or data integrity or a combination/repetition of major deficiencies that indicate a critical failure of systems
QA delegate has to conduct a primary Investigation on the deviation reported and evaluate the following information
1. Scope of the deviation - batch affected (both in-process and previously released)
2. Trends relating to (but limited to) similar products, materials, equipment and testing processes, product complaints, previous deviations, annual product reviews, and /or returned goods etc where appropriate.
3. A review of similar causes.
4. Potential quality impact.
5. Regulatory commitment impact.
6. Other batches potentially affected.
7. Market actions (i.e. recall etc)