Raktim Dey

Dy. Manager-Validations and Qualifications

Granules India Limited
What is Deviation?
 Deviation is the Departure from a documented or established procedure with respect to Product,
Patient or System.

 Deviation can be classified into two types: Planned Deviations and Un-Planned Deviations.

 Planned Deviations are initiated considering the risk associated with the deviation, hence are less
vulnerable to pose any impact on the Product quality, however a comprehensive risk assessment is
recommended to assess the impact of a planned deviation.

 Unplanned Deviations on the other hand is un-predictive and the extent of impact on product,
patient or system cannot be predetermined whatsoever. Therefore any unplanned deviations must be
thoroughly investigated to determine the root cause and a suitable CAPA shall be initiated to
mitigate the cause of Deviation and to prevent reoccurrences.

 A deviation is, when there is a failure to follow the instructions guiding the performance
of how an activity should be executed for optimal results. Deviations relate to non-
compliance and are a serious issue. While not all deviations are equal in their impact
on product and quality however all should be investigated.
Categorization of Deviations:
Category Description Examples

Any deviation that may cause significant effect on the safety • Product mix-ups
of the product and likely to have adverse physiological • Cross contamination of the
response to the patient, leading to severe damage or even product due to improper
death. cleaning.
Critical • Microbial contamination
• Use of obsolete batch
documents / methods
• Etc.

Any deviation that has produced or may produce a product • Machine breakdowns during
that does not comply to the marketing authorizations, processing
however not impacting the product quality attributes that • Use of non-complying raw
may have adverse physiological response to the patient, materials
leading to severe damage or even death. • Weighing/Process error
• Maximum hold time period
exceeding
Major • In-process controls not
performed as required.
• Misprinting of batch data
(Mfg., Expiry date in cartons)
• Color variations of packaging
materials w.r.t standard
artworks.
• Etc.
Categorization of Deviations:
Category Description Examples

Any deviation that does not have any direct impact on the • Minor errors in batch records
product quality or document not affecting the
(Strength, Identity, Purity and Safety) integrity of the data.
• Spillage of materials
Minor • Failure to meet environmental
conditions during
manufacturing.
DEVIATION HANDLING PROCEDURE:
 Deviation shall be identified by the user in respective areas.
 QA Personnel shall evaluate the nature of deviations and categorize the same into
Minor, Major or Critical deviations, based on the criticality and initial assessment.
 Once the categorization is done, a deviation shall be logged and the deviation
form shall be circulated to relevant cross functional team for further comments.
 Deviations shall be notified to all stake holders and Regulatory Affairs if required.
 An investigation committee shall be formed including Initiator, HODs for
respective departments, QA representative and other SMEs as per the
requirement and seriousness of the deviation.
 A thorough investigation shall be performed by the investigation team to
excavate the root cause of the noted deviation.
 Investigation can be carried out using various tools like Why-Why analysis, Fish
Bone Analysis, FMECA etc.
 Selection of the right tool for proceeding deviation investigation is of utmost
importance. Otherwise accurate root cause identification stands difficult.
DEVIATION HANDLING PROCEDURE (Contd.):
 Based upon the outcome of the investigation , a suitable CAPA shall be initiated
to mitigate the impact of deviation and restrict it’s future recurrences.
 The action item/items of the CAPA shall be assigned to relevant personnel with a
stipulated target date for completion of the assigned Action items.
 Once all the necessary CAPA is implemented, the deviation report shall be closed
with recommendations, if any.
 Basis to the nature of deviations, retrospective evaluation shall be carried out;
for example,
Case-I: If the root cause of a noted deviation is found to be human error,
retrospective review shall be performed, whether similar kind of deviation were
repeated in the past or not. If the same kind of deviations reported in the past,
the previously undertaken CAPA shall be revisited, for lacunas and a new CAPA
with more robust approach shall be proposed.
Case-II: if the noted deviation occurred for the first time , suitable CAPA shall be
initiated as agreed upon by the investigation team.
TRACKING AND CLOSURE OF DEVIATION:
 File all forms with any MOMs, follow up reports and CAPA documents with the
respective deviation form and deviation log shall be updated accordingly.
 If deviation is related to the product attributes, the deviation number shall be
reflected in Batch records and/or other relevant documents for future reference.
 Ideally all deviation investigations shall be closed with 30 working days from the
day of deviation reporting.
 If investigation of deviation cannot be completed within a span of 30 Days, an
extension request can be raised with appropriate justification. The extension
request shall be approved by Head QA/Designee.
 Trending of deviations shall be carried out on a monthly basis or quarterly basis as
defined in company SOPs.
 QA personnel shall keep a track on each deviation initiated w.r.t to the following,
but not limited to:
A) Deviation investigation status ( Closed/ Not-Closed)
B) Action items associated with the CAPA initiated in the purview of the
deviation closed/not-closed.
C) Coordinating with the initiating department for timely closure of the deviation
TRENDING OF DEVIATION:
 As already discussed, all the deviation logged should be trended along with
graphical representations.
 Following are the example how trending of the deviation are performed:
A) Number of deviations initiated by Cross Functional teams during the year 2020-
2021 (1st Quarter):
Department wise Deviations
Total No. of Deviation initiated
Departments No. of Deviations in the 1st
Quarter 1% Production
1%
1% 23% (Formulation)
Quality Control 11
Production (PFI)
Production 23
Quality Assurance
Technology Transfer 04
Quality Control
Formulation Development 02

50% Engineering
Packaging 16 21%

Engineering 09 3% Packaging
Development
Quality Assurance 08

The values and department mentioned are examples only

TRENDING OF DEVIATION (Contd.):
B) Type of Deviations reported during the year 2020-2021 (1st Quarter):

Category Wise Deviations Category of Deviation

6%
Category No. of Deviations in the 1st
Quarter Critical
45%
Critical 04 Major
49% Minor
Major 36
Minor 33

C) Sources of Deviations reported during the year 2020-2021 (1st Quarter):

Sources of Deviation
Sources. of Deviations
Sources No. of Deviations in the 1st 11%
Quarter 17%

MAN 27 Man

MACHINE 17 Machine

METHOD 09 Method
37%
12% Material
MATERIAL 12
Others
OTHERS 08

23%

The values mentioned are examples only

TRENDING OF DEVIATION (Contd.):
D) Status of Deviation during the year 2020-2021 (1st Quarter):

Status of Deviations
Open 12

Closed 61
Status of Deviation
16%

Closed
Open

84%

The values mentioned are examples only

 TRENDING OF DEVIATION (Contd.):
E) Trending of Repeated Deviations during the year 2020-2021 (1st Quarter):
Repeated Deviations
No. of times repeated
No. of
S. No. Nature of Deviation times
14 13
repeated 12
12 11
1 Missing of entries in Batch Records 13
10 9 9
Missing In-process checks as per
2 11 8
specified frequency
Delayed analysis of RM/ PM/ Finished 6 5 5
3 9 4
Product/ Stability Samples 4 3
2
Wrong acceptance criteria used for CV 2
4 2
samples 0

5 Saving the data in wrong folder 5

6 Line clearance failure 4

7 Compression machine breakdown 9

Weight print out not came for QC

8 3
Balance
No. of times repeated
9 Outer cartons colour variations 12
10 Others 5

The values and Nature of deviations mentioned are examples only

Summary and Conclusion for Deviation Trends
2020-2021 (1st Quarter):
Based upon the review of Deviation trend for the year 2020-2021 (1st Quarter)
following is the summary:

 All the deviations were investigated to find out probable root cause and suitable
CAPA were proposed.


 Deviations arisen due to personnel were found to be more in number for which
appropriate CAPA was proposed, concerned personnel were trained extensively to
avoid recurrence.
 Most of the deviations reported due to machine were of similar type and not
repeatedly occurred based on which it can be inferred that CAPA proposed was
efficient enough.
 However, for the repeated events proper action plan shall be derived upon
discussion with the cross functional teams to prevent reoccurrences
 The CAPAs which are under progress will be monitored till satisfactory ending
Hence it can be concluded that the Quality system is being maintained efficiently.
Summary and Conclusion for Deviation Trends 2020-2021
(1st Quarter):
Based upon the review of Deviation trend for the year 2020-2021 (1st Quarter)
following is the summary:

 All the deviations reported are categorized into Critical , Major and Minor.
 Appropriate CAPA is initiated for all Major and Critical Deviations.
 Through risk assessment were performed for all Major and Critical deviations.
 Deviations that were generated human error are taken care off, by appropriately
training the concerned personnel's in their respective areas.
 Wherever required additional check points implemented to mitigate the recurrences
of deviations.
 Tracking of all deviations are up to date and periodic coordination with CFTs are
established to close the deviation and associated CAPAs within stipulated timeline.
Contents of a Deviation Form, but not limited to:
 A typical example regarding the contents of a Deviation Form is as follows:
1. Deviation number _______________
2. Initiating Department _______________
3. Deviation Source: Man Material Method Machine Others
4. Description of Deviations: ___________________________________________
5. Affected Product/Batch/Material/ etc., if any:__________________________
6. Name & Signature of the Initiator______________
7. HOD Comments (Sign & Date) _________________________________________
8. Initial Assessment by QA:_____________________________________________
9. Classification of the Deviation: Minor Major Critical
10. Quality Risk Assessment report: Required / Not Required
11. Review Comments by CFTs : Production, QC, QA , Engineering , FR&D, RA, IT, Safety
etc.
Contents of a Deviation Form, but not limited to (Contd.):

 A typical example regarding the contents of a Deviation Form is as follows:

12. Details of Investigation:___________________________________________________
13. Root Cause / Probable Root cause: _________________________________________
14. Impact Assessment: ______________________________________________________
15. Proposed Corrective Actions:_______________________________________________
16. Proposed Preventive Actions: ______________________________________________
17. Conclusion, Summary and Deviation closure comments: _______________________

This is a template Deviation Form, the contents might vary based upon the company requirements.
What’s the best process for investigating deviations?
There is no single best process for investigating deviations. The ultimate goal of deviation
investigations is to determine why something went wrong, what caused it to go wrong,
and how to address the issue and prevent its recurrence. To achieve successful resolution
of deviations, keep the following general considerations in mind:

 A one-size investigation doesn’t fit all situations. Simple errors require simple
documentation while more serious deviations require broader investigations.

 The best tool to have is inquisitiveness. Ask yourself how far this deviation could extend.

 Widen your perspective. Look for ways to relate, not separate, similar issues.

 Human error is rarely a sufficient root cause.

 Always verify information or your instincts and never assume you are correct without
proper data to support your instincts.
“Human error as the most common cause of Deviation”-
This is not acceptable:

 The overuse of human error as a root cause to a deviation represents lost

opportunities to reduce future issues by masking the identity of the true root
cause.

 Herein is the human error in Human Error. The question that needs to be asked
during the initial investigation into a deviation is what caused the employee to
make the human error? Is it a system failure that led to human error?

 Asking this question early in the investigation leads to better root cause
identification and opportunities for continued improvement.
Brief Flow Diagram of Deviation Investigation
Identification of the
deviation Related to
What?

Immediate correction of the reported deviation and

Initial impact assessment (Containment Action)

When and
Where?
Categorization of the Deviation

Minor Major Critical What is

the
Impact on extent?
No impact on Impact on Product
Product Product Quality, Safety
Quality, Safety Quality, Safety and efficacy,
and efficacy and efficacy Impact on
Patients
Are there any What are the
• Impact assessment • Impact assessment interim immediate
• Corrective actions • Investigation
• CAPA
Controls? action taken?
and Closure of
• Closure of Deviation
deviation
• CAPA implementation and
effectiveness check.