Deviation Management

1. PURPOSE
To describe the method for;
1.1. Reporting and analyzing all deviations from standard operating procedures or established analytical
procedures or specifications.
1.2. Taking corrective/ preventive actions to minimize reoccurrence of deviations.
2. SCOPE
All warehousing, manufacturing and control departments (Quality control & Quality assurance) involved
in ensuring a quality product.
3. RESPONSIBILITY
3.1 The person(s) who actually witnessed the deviation in the first place is responsible for raising the
“Deviation Report”. It can be any person from Warehouse, Production, Quality Control, Quality
Assurance, Maintenance (e.g. product failure due to improper handling of equipment/system) or any
other relevant department of the company.
3.2 The Section Incharge / HOD of the concerned department is responsible for ensuring that Q.A
department is notified immediately.
3.3 In case of Deviation of QC Department from the established testing or calibration procedure, QC
Manager/ Senior QC Analysts are responsible for in time generation of “Deviation Report” form.
3.4 Q.A Manager is responsible for halting of work and withholding the test reports (as necessary)
investigating the matter, resumption of work (if required), ensuring proper corrective/ preventive action
is taken and final closing of the deviation report.
3.5 Q.A Officers during their daily assurance rounds also ensure that Deviation Report is raised by
concerned sections in case a deviation has occurred.
4. MATERIAL & EQUIPMENT
4.1 Material / Equipment related to deviation
5. PROCEDURE
5.1 DEFINITIONS
5.1.1 Minor Deviation
When the deviation does not affect any quality attribute, a critical process parameter, or an
equipment or instrument critical for process or control e.g.
a. Skip of FEFO principle (first expired-first out) in raw material handling.
b. Balance out of tolerance used to determine gross weight of raw materials upon reception.
c. Pressure differential out of established limits in class D washing area.
d. Inadequately trained personnel to perform warehouse cleaning activities.
e. Process temperature briefly out of specification.
f. Equipment malfunction not affecting the product etc.
5.1.2 Major Deviation
When the deviation affects a quality attribute, a critical process parameter, an equipment or
instrument critical for process or control, of which the impact to patients (or
personnel/environment) is unlikely
e.g.
a) Use of unapproved reference standard to test an API or drug product.
b) Inadequately trained personnel to perform sterility tests.
c) Production started without line clearance.
d) Gross misbehavior of staff in a critical aseptic process.
e) Operational parameter out of range for a parameter defined as non-critical.
f) Untrained personnel responsible for segregating the approved and rejected raw material in the
warehouse etc.
5.1.3 Critical Deviation

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When the deviation affects a quality attribute, a critical process parameter, equipment or
instrument critical for process or control, of which the impact to patients (or personnel or
environment) is highly probable, including life threatening situation, e.g.
a) Expired or rejected API component used.
b) Incorrect raw material or amount used.
c) Product mislabeled etc.
5.1.4 Deviation
Any non-compliance of an established GMP standard or of approved requirements, specifications
and standard operating procedures.
5.1.5 Planned Deviation
A decision to carry out a process in a different way from which it is established in a SOP, Method
or Manufacturing Batch Record (e.g., a reprocess) due to an unforeseen event.
Usually, planned deviations associated to onetime events, and change control to permanent
changes.
5.1.6 Unplanned Deviation
A decision to carry out a process in a different way from established SOP due to foreseen problem
Unplanned deviations associated to unexpected events.
5.2 DEVIATION REPORTING AND HANDLING SYSTEM
5.2.1 The person(s) who actually witnessed the deviation in the first place raises a “Deviation Report”
form by entering key points of deviation and immediately forwards it to Q.A Manager/ Q.A
Officer. If formulation/packing/analytical method or specification change is needed then
Deviation Report Form must be linked with a “Product Change Request form”.
5.2.2 Q.A Manager/ Q.A Officer assign the “Deviation Report” number and enroll it in the “Deviation Log
book”. The numbering system followed is as follows;
Dev./YY/Sr #, Dev./15/001
5.2.3 “Planned deviation” is frequently used to describe a decision to carry out a process in a different way
from which it is established in a SOP, Method or Manufacturing Batch Record (e.g., a reprocess)
due to an unforeseen event. Planned deviations need to be fully documented and justified.
Usually, planned deviations associated to onetime events, and change control to permanent
changes.
5.2.4 Correction
a. Respective department has to provide root cause and immediate actions in-case of planned
deviation.
b. Q.A Manager approves the immediate action(s) to be taken e.g. segregation, sorting, holding,
reworking, retesting etc.
c. Q.A department ensures that these actions are taken as soon as the decision has been made.
d. Minor deviation may not require detail investigation and can be closed after immediate action.

5.2.5 Root cause Investigation & Risk Assessment

a. Incase of Major or Critical Deviation personnel are assigned by QA Manger to investigate the
root cause.
b. Investigation Team investigates the root cause by using the “5 Whys” or “Ishikawa Fish Bone
Diagram” and Quality Risk Management Principles.
 The “5 Whys” refers to a series of sequential questions (i.e. each response given is asked
“why”, normally from 3 up to 5 times). This exercise allows a thorough understanding of the
underlying or root causes of the deviation, which may be related to a systemic problem.
 The Fish bone diagram is a cause-effect type of analysis where the product / process is the
main spine, the effect is the actual nonconformance, and the secondary spines are the
different factors or causes that could have affected or “caused” the deviation (i.e., materials,
controls, personnel, equipment, procedures, etc.).
c. All the probable causes are listed and most probable cause is tested to check whether it is the
cause of deviation.
5.2.6 Corrective / Preventive Actions
a. Actions to be taken, person responsible for taking the action along with expected completion
date are noted on the Deviation Report.
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b. The person(s) responsible for corrective/preventive action provides data or references proving
that the corrective/ preventive actions have been completed.
5.2.7 After confirmation that all actions have been completed, Q.A closes the Deviation report and
updates the deviation log book”.
5.2.8 After closing the Deviation Report, QA does follow up to check whether the corrective /
preventive actions were effective or not and that the resulting change was communicated to all
concerned parties or not. The follow up is done within a week of deviation closing.
5.2.9 The copy of completed Deviation Report related to Product batch (regarding manufacturing and
testing is retained in the Deviation record file.
5.2.10 After every year QA does a trend analysis of all raised Deviation reports and bar graphs prepared.
5.2.11 The trend analysis report is prepared by QA dept. and forwarded to Executive Director for
comments and signatures.
5.2.12 Deviation Report if still open after one year must be evaluated by Q.A. Manager and if delay is
justified then existing report should be closed and a new report with same issue should be raised.

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