A standard procedure for managing quality assurance deviations
What is a deviation?
A Deviation is a deviation 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. Following are some examples of deviations raised from different functional areas of the business:
2. Production deviation: 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, supplier, or corporate audits.
6. Customer Service Deviation: Raised to track implementation measures 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 Material Claim: Filed to document any issue related to nonconforming, superseded, or obsolete imported raw materials/components, packaging, or finished products.
9. System Routing Deviation – Generated to track changes made to the BOM as a result of a design change.
When to report the deviation:
A Deviation should be raised when there is a deviation from the methods or controls specified in the manufacturing documents, material control documents, standard operating procedures for products and confirmed out-of-specification results and from the occurrence of an event and observation that suggests 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.
The deviation is required to be reported 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 create an immediate and significant risk to product quality, patient safety, or data integrity or a combination/repetition of significant deficiencies that indicate a critical failure of 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 by a regulatory agency or a combination/repetition of “other” deficiencies that indicate a failure of the 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 reported 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 fact with a title in the table of the form 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 Assurance Manager or his designee. QA Manager must justify whether 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 disposal 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 must be assigned to area representatives. Follow-up tasks must be completed within 30 business days of observing the deviation. If a deviation with CFI cannot be completed within 30 business days, an interim report must be generated detailing the reason for the delay and progress thus far.
After the successful completion of the follow-up tasks, the deviation should be completed and attached with the batch report/audit report/product complaint report/safety investigation report, as appropriate.
What to check during deviation assessment:
The quality control delegate should conduct a primary investigation on the reported deviation and evaluate the following information
1. Scope of the deviation: affected batch (both in process and previously released)
2. Trends related to (but limited to) similar products, materials, equipment and testing processes, product complaints, prior 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 regulatory commitment.
6. Other lots potentially affected.
7. Market actions (ie recovery etc.)