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A Standard Procedure For Deviation

This document outlines standard procedures for handling deviations from normal processes. It defines what a deviation is and provides examples of different types of deviations. It describes when deviations should be reported, how they are classified based on risk level, how they are managed, and what should be evaluated during the deviation assessment process. Deviations are recorded in Deviation Reports to ensure compliance and continuous improvement.

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GAURAV SHARMA
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905 views

A Standard Procedure For Deviation

This document outlines standard procedures for handling deviations from normal processes. It defines what a deviation is and provides examples of different types of deviations. It describes when deviations should be reported, how they are classified based on risk level, how they are managed, and what should be evaluated during the deviation assessment process. Deviations are recorded in Deviation Reports to ensure compliance and continuous improvement.

Uploaded by

GAURAV SHARMA
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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A Standard Procedure For Deviation

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 ( Home Page. 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 ( Home Page. recall etc)

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