What is a deviation?
A Deviation is a departure from standard procedures or specifications that results in nonconforming material and/or processes or where there have been unusual or unexplained events that have the potential to affect product quality, system integrity, or personal safety. For GMP compliance and the sake of continuous improvement, these deviations are recorded in the form of a Deviation Report (DR).
Types of deviations:
1. Below are some examples of deviations raised from different functional areas of the business:
2. Production deviation: It usually occurs during the manufacturing of a batch production.
3. EHS Deviation: Increased due to environmental, health, and safety hazards.
4. Quality Improvement Deviation – May be increased if a potential weakness has been identified and implementation will require project approval.
5. Audit Deviation – Generated to flag nonconformity identified during internal, external, vendor, or corporate audits.
6. Customer Service Deviation: Raised to track implementation actions related to customer complaints.
7. Technical deviation: can be generated by validation discrepancies. For example: changes in the Manufacturing Instruction.
8. Material Claim: Filed to document any issues related to non-conforming, replaced, or obsolete imported raw materials/components, packaging, or finished goods.
9. System Routing Deviation – Generated to track changes made to the BOM as a result of a design change.
When to report deviation:
A Deviation should be raised when there is a deviation from the methods or controls specified in manufacturing documents, material control documents, standard operating procedures for confirmed out-of-specification products and results, and from the occurrence of an event and observation suggesting the existence of an actual problem or potential problems related to quality.
A deviation should be reported if a trend is observed that requires further investigation.
All batch production deviations (planned or unintended) covering all manufacturing facilities, equipment, operations, distribution, procedures, systems, and record keeping must be reported and investigated for corrective and preventative action.
It is required to inform the deviation regardless of the final disposition of the lot. If a lot is rejected, a deviation report is still required.
Different levels of deviation risks:
To facilitate risk assessment, any deviation can be classified into one of three levels 1, 2 and 3 based on the magnitude and severity of a deviation.
Level 1: Critical Deviation
Deviation from current company standards and/or regulatory expectations that creates an immediate and significant risk to product quality, patient safety, or data integrity or a combination/recurrence of significant deficiencies indicating a critical product failure. the systems
Level 2: Serious Deviation
Deviation from company standards and/or current regulatory expectations that pose a potentially significant risk to product quality, patient safety, or data integrity or that could result in significant observations from a regulatory agency or combination/recurrence of “other” deficiencies indicating failure of system(s).
Level 3: Standard Deviation
Observations of a less serious or isolated nature that are not considered Critical or Major, but require correction or suggestions on how to improve systems or procedures that may be compliant but would benefit from improvement (eg, incorrect data entry).
How to manage the notified deviation:
The department manager or delegate should initiate the deviation report using a standard deviation form as soon as a deviation is found. Write a brief description of the event with a title in the form table and notify the Quality Assurance department within one business day to identify the investigation.
Quality control has to assess the deviation and assess the potential impact on product quality, validation and regulatory requirements. All completed deviation investigations must be approved by the Quality Control Manager or his/her designee. QA Manager must justify if the deviation is of a critical, serious or standard nature. For a deviation of a critical or serious nature, the QA delegate has to organize a cross-functional investigation.
For a standard type deviation, a cross-functional investigation (CFI) is not necessary. Immediate corrective actions must be completed prior to final disposition of a lot. The final disposal of the batch is the responsibility of the Quality Assurance Department.
If a critical or serious deviation leads to a CFI, corrective and preventive actions must be determined and follow-up tasks assigned to area representatives. Follow-up tasks must be completed within 30 business days of the deviation being observed. If a deviation with CFI cannot be completed within 30 business days, an interim report should be generated detailing the reason for the delay and progress to date.
After successful completion of the follow-up tasks, the deviation must be completed and attached with the batch report/audit report/product complaint report/safety investigation report, as applicable.
What to check during deviation evaluation:
The QC Delegate must conduct a primary investigation into the reported deviation and evaluate the following information
1. Scope of the deviation: batch affected (both in process and previously released)
2. Trends related to (but limited to) similar products, materials, equipment and testing processes, product complaints, past deviations, annual product reviews and/or product returns, etc., as applicable.
3. A review of similar causes.
4. Potential impact on quality.
5. Impact of the regulatory commitment.
6. Other batches potentially affected.
7. Market actions (ie recovery, etc.)
