Deviation and root cause analysis in Pharma

• 1. Title: Deviation and Root Cause Analysis Content

• Deviation and Type of Deviation
• Regulatory expectation
• Basic process flow for Deviation handling
• Root Cause Analysis Tools and Technique for Root
Cause
• 2. WHAT IS DEVIATION? Deviation is a departure from a
documented standard or procedure Deviations are measured
differences between observed value and expected or normal
value for a process or product condition, or a departure from
approved procedure or established standard or specification
There are two types of deviations
• 1)Planned Deviation : Planned deviations, which are described,
and pre-approved deviation from the current operational
document/system, covering a specified period of time or number
of batches. Planned deviation shall be approved before execution
• 2)Unplanned Deviation: Unplanned deviations also called as incident.
It is defined as unplanned or uncontrolled event in the form of non-
compliance from the designed systems or procedures at any stage of
manufacturing, packaging, testing, holding and storage of drug
product due to system failure or equipment breakdown or manual
error. WHY INVEISTIGATE DEVIATION? To prevent reoccurrence
Failures are cost to company Failures can have adverse health impact
on the consumers if go undetected To identify the cause and take
corrective actions To identify other similar situations and take
preventive actions Continuous improvement Regulatory requirement
• 3. Regulatory Expectation
• “Any unexplained discrepancy…shall be thoroughly
investigated…The investigation shall extend to other batches
…that can have been associated with the specific failure or
discrepancy. A written record of the investigation shall be made
and shall include the conclusions and follow-up 21 CFR 211.192
•“Any deviations from instructions or procedures should be
avoided as far as possible. If a deviation occurs, it should be
approved in writing by a competent person…”
• Any significant deviations [from defined procedures
and instructions] are fully recorded and investigated EC
Guide to GMP, Chapter 5 (5.15)
• Any deviation from established procedures should be
documented and explained. Critical deviations should
be investigated, and the investigation and its
conclusions should be documented. ICHQ7A
• The organization should ensure process outputs, products, and services
that do not conform to requirements are identified and controlled to
prevent unintended use or delivery. The organization should take
appropriate action based on nature of nonconformity and its impact on
conformity of products and services. This is applicable also to
nonconforming products and services detected after delivery of products
during or after provision of service ISO 9001:2015,Clause 8.7 When a
deviation occurs the responsible firm must undertake and investigation to
determine what went wrong and what damage, if any , the product might
have suffered.
• 4. Basic Process flow for Deviation handling
Identification of deviation Immediate correction &
initial impact assessment (Containment action)
Define and classified deviation Major :Impact on
product quality Critical: Impact on product quality,
safety & efficacy Minor: No impact on product
quality, safety & efficacy
•Impact Assessment
•Corrections & closure of incident
•Impact Assessment
•Investigation •Corrections / CAPA
•Closure of incident
•CAPA implementation & effectiveness check
Related to what? When and Where? What is the
extent? What are the immediate action taken Any
interim control
• 5. Root Cause Analysis
• Root cause analysis(RCA) is a method that used to address a deviation
or non conformance in order to get to the true root cause of the
problem.
• RCA is application of a series of well known technique which can
produce a systematic, quantified and documented approach to the
identification, under stand and resolution of under causes.
• As a PROCESS it is more effective when it’s adequately defined,
provisioned with appropriate resources, and performed by trained
personnel.
• Goals - Failure identification - Failure analysis - Failure
resolution
• Iterative Process: - Complete prevention of recurrence
by a single intervention is not always possible. Basic
steps involved in Root Cause Analysis Define Event
Gather data Investigation Identify the Root Causes
Eliminate items that are not root causes
Recommendation s CAPA Improvement
• 6. RCA Tools and Technique
• Brainstorming A creative approach to generate a high volume of ideas
free of criticism and judgment.
• What are the rules?
• Every idea is captured.
• Ideas are written as said.
• No comments, discussion, or criticism.
• Everyone contributes.
• Five Whys? The 5 Whys is a questions‐asking method used to explore the
cause/effect relationships underlying a particular problem. Ultimately, the
goal of applying the 5 Whys method is to determine a root cause of a
defect or problem. Keep asking Why till you reach root cause
• Cause and Effect Diagram Technique to graphically identify and organize
many possible causes of a problem Advantages - Helps to discover the
most likely ROOT CAUSES of a problem Teach a team to reach a common
understanding of a problem.  Fishbone Analysis Components : -  Head
of a Fish : Problem or Effect  Horizontal Branches : Causes Sub –
branches : Reason
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