A Standard Procedure For Quality Assurance Deviation Management

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 uncommon or unexplained events which have the possible 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 possible 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 Material Complaint – raised to document any issues with regards to non-conforming, superseded or out of use raw materials/elements, packaging or imported finished goods.

9. System Routing Deviation – raised to track changes made to Bill of materials as a consequence of an Artwork change.

When to Report Deviation:

A Deviation should be raised when there is a deviation from methods or controls stated 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 possible 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, dispensing, procedures, systems and record keeping must be reported and investigated for corrective and preventative action.

Reporting deviation is required in spite of of final batch disposition. If a batch is rejected a deviation reporting is nevertheless 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 extent and seriousness of a deviation.

Level 1: basic Deviation

Deviation from Company Standards and/or current regulatory expectations that provide immediate and meaningful risk to product quality, patient safety or data integrity or a combination/repetition of major deficiencies that indicate a basic failure of systems

Level 2: Serious Deviation

Deviation from Company Standards and/or current regulatory expectations that provide a potentially meaningful risk to product quality, patient safety or data integrity or could potentially consequence in meaningful 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 secluded character that are not deemed basic or Major, but require correction or suggestions given on how to enhance systems or procedures that may be compliant but would assistance from improvement (e.g. incorrect data entry).

How to Manage Reported Deviation:

The department Manager or delegate should begin 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 clarify the investigation.

QA has to estimate the deviation and estimate the possible 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 basic, Serious or Standard in character. For a deviation of either basic or serious character QA delegate has to position a Cross Functional Investigation.

For a standard kind 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 basic or serious deviation leads to a CFI, corrective and preventive actions should be determined and follow up responsibilities should be stated to area representatives. Follow up responsibilities 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 responsibilities 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 dominant Investigation on the deviation reported and estimate the following information

1. Scope of the deviation – batch affected (both in-course of action and before released)

2. Trends relating to (but limited to) similar products, materials, equipment and testing processes, product complaints, past deviations, annual product reviews, and /or returned goods etc where appropriate.

3. A review of similar causes.

4. possible quality impact.

5. Regulatory commitment impact.

6. Other batches potentially affected.

7. Market actions (i.e. ingemination etc)

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