A Standard Procedure For Quality Assurance Deviation Management

What is a Deviation:
A Deviation is a departure from standard procedures or specifications resulting in non-conforming material and/or processes or where there have been unusual or unexplained events which have the potential to impact on product quality, system integrity or personal safety. For compliance to GMP and the sake of continuous improvement, these deviations are recorded in the form of Deviation Report (DR).

Types of Deviations:
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 Material Complaint - raised to document any issues with regards to non-conforming, superseded or obsolete raw materials/components, packaging or imported finished goods.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.

When to Report Deviation:
A Deviation should be raised when there is a deviation from methods or controls specified in manufacturing documents, material control documents, standard operating procedure for products and confirmed out of specification results and from the occurrence of an event and observation suggesting the existence of a real or potential quality related problems.

A deviation should be reported if a trend is noticed that requires further investigation.
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.

Reporting deviation is required regardless of final batch disposition. If a batch is rejected a deviation reporting is still required.

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

Level 2: Serious Deviation
Deviation from Company Standards and/or current regulatory expectations that provide a potentially significant risk to product quality, patient safety or data integrity or could potentially result in significant observations from a regulatory agency or a combination/repetition of "other" deficiencies that indicate a failure of system(s).

Level 3: Standard Deviation
Observations of a less serious or isolated nature that are not deemed Critical or Major, but require correction or suggestions given on how to improve systems or procedures that may be compliant but would benefit from improvement (e.g. incorrect data entry).

How to Manage Reported Deviation:
The department Manager or delegate should initiate the deviation report by using a standard deviation form as soon as a deviation is found. Write a short description of the fact 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 evaluate the deviation and assess the potential impact to the product quality, validation and regulatory requirement. All completed deviation investigations are to be approved by QA Manager or delegate. QA Manger has to justify wither the deviation is a Critical, Serious or Standard in nature. For a deviation of either critical or serious nature QA delegate has to arrange a Cross Functional Investigation.

For a standard type deviation a Cross functional Investigation (CFI) is not necessary. Immediate corrective actions have to be completed before the final disposition of a batch. Final batch disposition is the responsibility of 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 should be completed within 30 business days of the observation of deviation. If a deviation with CFI can not be completed within 30 business days, an interim report should be generated detailing the reason for the delay and the progress so far.

After successful completion of the Follow up tasks Deviation should be completed and attached with the Batch Report /Audit report/ Product complaint report /Safety investigation report as appropriate.

What To Check During The Deviation Assessment:
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)

Essential elements of a good quality management system are described in this article for pharmaceutical industry. Check more in Pharmaceutical Quality Procedures