Deviation management System

• Deviation management is the systematic process of identifying,

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Deviation management System
What Is a Deviation?
• A deviation is any departure from approved processes, procedures,
instructions, specifications, or established standards.

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Deviation management System
What Are the Different Classification Types of Deviation?
• There are two main classification types of deviations: planned and
unplanned deviations.

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Planned Deviation
• Planned deviations refer to pre-approved and intentional deviations from standard procedures or processes.
• These deviations are planned and justified in advance, serving various purposes, such as process
improvement, method validation, and temporary process changes.
• Some examples of planned deviations include:
• Implementing a temporary manufacturing process change to test and validate potential efficiency
improvements.
• Using an alternative raw material as part of a trial to assess its suitability without affecting product quality.
• Temporarily adopting an alternative testing method to validate its accuracy and reliability compared to the
standard method.
• Change control and change requests are essential components of managing planned deviations in a controlled
and systematic manner.
• Change request documents are part of the change control process. They provide a formal and structured way
to propose and justify the planned deviation, outlining its purpose, scope, and potential impact.
• The change control process in the pharmaceutical industry ensures that relevant personnel can assess and
approve the proposed change, considering its implications on product quality, safety, and regulatory
compliance.

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Unplanned Deviations:
• Unplanned deviations refer to a departure from approved procedures
without prior notice or intention.
• Various factors, such as equipment malfunction, employee error,
environmental events, or others, can cause them.
• Unplanned deviations can significantly impact product quality and
safety, and such deviations should be investigated promptly to identify
the root cause and prevent them from happening again.

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How Are Events Categorized Based on Risk?
• Deviations are categorized based on risk levels to assess their potential
impact on product quality, patient safety, and the regulatory
requirements companies are subject to:
• The risk-based deviation categories usually include:
1. Incidents
2. Minor deviations
3. Major deviations
4. Critical deviations

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How Are Events Categorized Based on Risk?

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Incident
• An incident is an unplanned or uncontrolled event that does not
directly affect the manufacturing process parameters or product
quality.
• Incidents are generally unrelated to GMP requirements and are often
not considered deviations.
• It does not affect a product attribute, a manufacturing operational
parameter or affect the product's quality
• An Incident that does not require a formal investigation and can be
corrected immediately

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Incident
Examples of incidents are listed below:
• A minor typographical error in the documentation that does not affect
the overall process or product outcome.
• Manually cleaned equipment that does not meet visual inspection.
• Temporary power failure in a warehouse where no temperature
sensitive materials are stored, with no temperature excursion from the
established range.

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Minor Deviations:
• A minor deviation involves divergences from established procedures
or standards that have a noticeable but limited impact on product
quality or regulatory compliance.
• Slightly impact on product SISPQ (Strength, Identity, Stability, Purity
and Quality)

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Major Deviations:
• A major deviation indicates a significant departure from established
procedures or standards that can considerably impact pharmaceutical
drug quality and regulatory requirements.
• Moderate impact on product SISPQ (Strength, Identity, Stability,
Purity and Quality)

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Critical Deviations:
• A critical deviation denotes a severe nonconformance from established
procedures or standards that poses meaningful risks to product quality,
patient safety, or compliance with applicable requirements.
• Examples of critical deviations are given below:
• Contamination of a critical raw material used in the production process
that may lead to a serious health risk for patients.
• The failure of the HEPA filters in the cleanroom that may lead to
potential contamination risks and compromise the integrity of the
controlled environment.

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Handling of the Deviations procedure:
• Identification
• Reporting
• Investigation
• Documentation
• Implementation

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1. Identification of the Deviation:
• Phase 1: Event documentation
• The first thing to be done when a deviation has been discovered is to
document the existing data. Immediate actions may become
necessary as soon as the deviation occurs, to eliminate the defect and
remove any threat to the quality of the intermediate stage or of the
product

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2. Reporting of the deviation:
• Phase 2: Description of problem
• Once the event has been happened, the observer will raise an event
notification illustrating a comprehensive description of the case by
answering all the following questions:
1. What ?
2. When ?
3. Where ?
4. Who ?
5. Why ? If known
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2. Reporting of the deviation:
• Then mention the Immediate actions that have been taken:
• Immediate actions:
Actions to be taken by deviation issuing responsible person to safe
guard the product or segregation of the defective product& will be
performed under the supervision of department manager/ supervisor.

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3. Failure investigation:
• Investigation:
• All timely, unbiased, thorough, well documented, and scientifically sound
steps, studies, reviews used to determine the root cause of undesired
situations using Root Cause Analysis.
• Root Cause:
• The basic cause for the deviation, which if corrected, will prevent
recurrence of the deviation i.e. is the specific reason that occurred and led to
get an undesirable situation, it is the main target of the investigation.
• Root Cause Analysis:
• Is a tool designed to help identifying not only what and how an event
occurred, but also, why it happened by asking Why? Questions and digging
deep into the situation until the fundamental reason for the problem is
found.
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3. Failure investigation:
• Investigation Tools:
1) 6M root cause analysis:
➢Method: Will be checked vs, identity, validity of test methods implementation.. .etc.
➢Machine: Will be checked vs. the qualification documents, calibration document & its due
date, critical parameters entered to the equipment.. .etc.
➢Man: will be checked Vs the training of the employee, qualifications of the employee,
accuracy of the employee, overload.. .etc.
➢Material: will be checked from the point of purchase request of this shipment; validity of
material, supplier of the material analysis, quantity dispensed. ... etc.
➢Measurements: will be checked Vs unit of measure, calculation, quantity used...etc.
➢Mother nature: will be checked Vs any interaction could affect the accuracy of the result
overload, non-comfortable environment, temp, RH %, differential pressure, AHU or
HVAC problem.. .etc.

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3. Failure investigation:
2) 5 Why:

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3. Failure investigation:
3) 5W+H
➢What: Focuses on providing a clear description of the problem, specifying its type and
the conditions under which it occurs.
➢Who: Refers to the individuals related with the problem including those affected by the
problem and those contributed to its occurrence.
➢Where: Indicates the location or place of the problem or situation, including the
specific process where the problem is occurring.
➢When: Involves the time or duration of the problem or situation, including details such as
dates, deadlines, and other time-related information
➢Why: Focuses on the reasons or motivations behind the problem or situation and the need
for taking actions to address it. This can be conducted as a standalone exercise known as
the 5 Whys
➢How: Focuses on the mechanics of how something has happened. It may cover the
methods, tools, resources, and costs involved.

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3. Failure investigation:
4) Brain Storming:
• a group problem-solving technique that involves the spontaneous
contribution of ideas from all members of the group and interviews
with the involved persons.

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3. Failure investigation:
▪ After following the findings that observed divided to:
1. Relevant gaps (Root cause)
2. Irrelevant gaps (other defects found during investigation but does
not lead to the root cause).
• the investigation team reaches the root cause or at least the potential
root causes of the problem then investigation team will detect the
corrective action, preventive action

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3. Failure investigation:
• Impacted product or batches (Final Disposition) status will be:
• No product/s shall be shipped until:
❖The related Deviation report is completely investigated & closed in
case of critical cases.
❖Completing the decision taken for the batch (e.g. 100% inspection,
sorting . . .etc).

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4. Documentation
Phase 4: Specifying actions
Corrective Actions:
• Corrective actions (CA) take steps to fix the cause of a problem after
the problem has occurred
Preventive Actions:
• preventive actions (PA) involve noticing the problem before it occurs,
and taking steps to address the cause of the problem before it happens.

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4. Documentation
• CAPA:
• An action plan for each Deviation report will contain:
• The list of required corrective actions, preventive actions & related
actions.
1. The responsible department and/or person.
2. Expected due date.
3. CAPA reference number

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5. Implementation:
• Phase 5: Implementing the actions
• The actions are implemented in accordance with the approved Action
Plan. The status of the individual actions can be monitored or
supervised both manually and/or by a supporting computer system
• Test for Effectiveness
• The test for effectiveness of the actions should be performed in a
timely fashion in order to keep the suitability of the actions

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