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 non-conforming 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. To meet GMP and continually improve, these deviations are recorded in the form of a Deviation Report (DR).
Types of deviations:
1. Below are some examples of deviations arising from different functional areas of the business:
2. Production deviation: usually arises during the manufacture of a batch production.
3. EHS Deviation – Raised due to environmental, health and safety hazards.
4. Quality improvement deviation: can be raised if a potential weakness has been identified and implementation will require project approval.
5. Audit deviation: it is activated to indicate the non-conformities identified during the internal, external, supplier or corporate audits.
6. Customer Service Deviation – Raised to track implementation actions related to customer complaints.
7. Technical deviation: may arise due to validation discrepancies. For example: changes in the manufacturing instruction.
8. Material Claim – filed to document any issues regarding non-conforming, replaced, or obsolete raw materials / components, packaging, or imported finished products.
9. System Routing Deviation – Generated to track changes made to the bill of materials as a result of a change in artwork.
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 procedure for products and confirmed results out of specification and the occurrence of an event and observation that suggests the existence of an actual event or potential quality-related issues.
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 should be reported and investigated for corrective and preventive action.
It is necessary to report the deviation regardless of the final disposition of the lot. If a batch is rejected, a variance report is still required.
Different levels of risk of deviation:
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 the deviation.
Level 1: critical deviation
Deviation from company standards and / or current regulatory expectations that provide an immediate and significant risk to product quality, patient safety, or data integrity or a combination / repeat 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 lead to important observations from a regulatory agency or a combination / repetition of “other” deficiencies indicating a 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 comply with but would benefit from improvement (for example, incorrect data entry).
How to manage reported deviation:
The department manager or delegate should start 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 table on the form and notify the Quality Assurance department within one business day to identify the investigation.
QA 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 delegate. QA Manger has to justify whether the deviation is critical, serious or standard in nature. For a deviation of a critical or serious nature, the QA delegate should organize a cross functional investigation.
For a standard deviation, a cross functional investigation (CFI) is not necessary. Immediate corrective actions must be completed prior to final disposal of a lot. 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 should be determined and follow-up tasks should be assigned to area representatives. Follow-up tasks must be completed within 30 business days of observing the deviation. If a deviation cannot be completed with CFI within 30 business days, an interim report must be generated detailing the reason for the delay and the progress thus far.
After 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 applicable.
What to check during the deviation assessment:
A QA delegate should conduct a primary investigation on the reported deviation and evaluate the following information
1. Scope of the deviation: affected lot (both in process and previously released)
2. Trends related to (but limited to) similar test products, materials, equipment and processes, product complaints, prior deviations, annual product reviews and / or returned products, etc., where applicable.
3. A review of similar causes.
4. Potential impact on quality.
5. Impact of the regulatory commitment.
6. Other potentially affected lots.
7. Market actions (ie recovery, etc.)
