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Presenting CAPA, Root Cause Analysis, and Risk Management Information


V Group Introducing in-depth information about CAPA, Root Cause Analysis, and Risk Management under the Pharmaceutical domain and describes the quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of nonconforming product, processes, and other quality problems. – PowerPoint PPT presentation

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Title: Presenting CAPA, Root Cause Analysis, and Risk Management Information

CAPA, Root Cause Analysis, and Risk Management
Documented by Shubham Khandelwal
What is CAPA?
  • Corrective and Preventative Action (CAPA) is a
    system of quality procedures required to
    eliminate the causes of an existing nonconformity
    and to prevent recurrence of nonconforming
    product, processes, and other quality problems.

CAPA is Part of the Seven Quality Subsystems
  • Terminology

Nonconforming Material or Process (Discrepancy) -
Any material or process that does not meet its
required specifications or documented procedure.
Correction Refers to repair, rework, or
adjustment and relates to the disposition of an
existing nonconformity. Corrective Action - To
identify and eliminate the causes of existing
nonconforming product and other quality
problems. Preventive Action - To identify and
eliminate the causes of potential nonconforming
product and other quality problems.
Nonconformance Control Steps
1. Identify nonconforming items.
2. Move items away from work area.
3. Decide what should be done.
4. Take remedial action.
Components Of Corrective Action
  • Collect and analyze data to identify
  • product, incidents, concerns or other quality
  • problems that would be worth the effort to
  • Investigate and identify root cause
  • Implement the correct solution
  • Verify or validate effectiveness

Corrective Action (CA) Steps
1. Would the correction be worth the effort.
2. Identify root cause.
3. Change the system.
4. See if it worked.
Ascertaining Root Cause
  • Root cause and the weed
  • Weeds can be difficult to remove once they
  • start to grow and spread.
  • On the surface, the weed is easy to see.
  • However, the underlying cause of the weed, its
    root, lies below the surface and is not so
  • To eradicate the weed you have to get below the
    surface, identify the root, and pluck it out.
  • Thus, you have to go beyond the obvious,
    ascertain an accurate route cause, so the
    appropriate corrective action can be pursued to
    prevent recurrence.

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Tools for Ascertaining Root Cause
  • Include the following
  • The five whys, a simplistic approach exhausting
    the question Why?.
  • Fishbone diagram, a cause and effect diagram also
    known as the Ishikawa diagram.
  • Pareto analysis, the 80/20 rule premised on a
    predefined database of known problems.
  • Fault tree analysis, a quantitative diagram used
    to identify possible system failures.
  • Failure modes and effects analysis (FMEA), which
    lists all potential failure modes and the
    potential consequences associated with each
    failure mode.

The Five Whys Technique
  • The 5 Whys technique is a simpler form of fault
    tree analysis for investigations, especially
    investigations of specific accidents as opposed
    to chronic problems.
  • The 5 Whys technique is a brainstorming technique
    that identifies root causes of accidents by
    asking why events occurred or conditions existed.
  • The 5 Whys process involves selecting one event
    associated with an accident and asking why this
    event occurred. This produces the most direct
    cause of the event.
  • Drill down further indicating if their were any
    sub-causes of the event, and ask why they
  • Repeat the process for the other events
    associated with the accident.

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Disadvantages of the 5 Whys Technique
  • This time consuming brainstorming process may be
    tedious for team members trying to reach
    consensus. This is especially true for large
  • Results are not reproducible or consistent.
    Another team analyzing the same issue may reach a
    different solution. The particular brainstorming
    process that was utilized may be difficult, if
    not impossible, to duplicate.
  • Root causes may not be identified. The 5 Whys
    technique does not provide a means to ensure that
    root causes have been identified.

Creating a Fishbone Diagram Initial Steps
  • A fishbone diagram is a cause and effect diagram
    that looks much like a skeleton of a fish.
  • It is also called a Ishikawa diagram after the
    inventor of the tool, Kaoru Ishikawa who first
    used the technique in the 1960s.
  • To draw the diagram, first list the problem/issue
    to be studied in the head of the fish.
  • Label each bone of the fish. The major categories
    typically used are The 6 Ms Machines, Methods,
    Materials, Measurements, Mother Nature
    (Environment), Manpower (People).
  • Repeat this procedure with each factor under the
    category to produce sub-factors.
  • Continue asking, Why is this happening? and put
    additional segments under each sub-factor.

Simple Fishbone Diagram Bioburden Levels Out of
Creating a Fishbone Diagram Further Steps
  • Continue adding sub-factors to your diagram
    until you no longer get useful information as you
    ask, Why is that happening?
  • Analyze the results of the fishbone after team
    members agree that an adequate amount of detail
    has been provided under each major category. Do
    this by looking for those items that appear in
    more than one category. These become the most
    likely causes.
  • For those items identified as the most likely
    causes, the team should reach consensus on
    listing those items in priority order with the
    first item being the most probable cause.

More Detailed Fishbone Diagram
Simple Fishbone Diagram Patient Received
Incorrect Dose of Medication
Equipment needs not met
Very Detailed Fishbone Diagram Increased
Outpatient Department Waiting Time
Advantages of Fishbone Diagrams
  • Fishbone diagrams do provide value in that they
  • (1) organize potential causes,
  • (2) help a team to think through causes they
    might otherwise miss, and
  • (3) provide a living document that shows the
    status of all potential causes and whether they
    have been proved/disproved/acted upon.

Limitations of Fishbone Diagrams
  • One danger with fishbone diagrams is that they
    create a divergent approach to problem solving,
    where the team expends a great deal of energy
    speculating about potential causes, many of which
    have no significant effect on the problem.  
  • This approach may leave a team feeling frustrated
    and hopeless.
  • Therefore in deciding which problems to explore
    the team needs to closely look at the evidence in
    order to separate fact from opinion.

Pareto Charts
  • The Pareto chart is a bar graph whose invention
    is attributed to the Italy economist, Mr.
    Vilfredo Pareto.
  • In 1906, Vilfredo Pareto made the well-known
    observation that 20 of the population owned 80
    of the property in Italy.
  • This was later generalized by Joseph M. Juran and
    others into the so-called Pareto principle that
    for many phenomena, 80 of consequences stem from
    20 of the causes.
  • In the Pareto chart, the lengths of the bars
    represent frequency or cost (time or money), and
    are arranged with longest bars on the left and
    the shortest to the right. In this way the chart
    visually depicts which situations are more
    significant (a Pareto analysis).

Pareto Frequency Chart
Shipping Documents Complaints 4th
Quarter 2014
Results This Pareto Chart shows that approx. 70
of the document complaints reported involve
quality certificates. Significance More care
should be given to how quality certificates are
written and added to the shipping package.
When to Use a Pareto Chart
  • When analyzing data about the frequency of
    problems or causes in a process.
  • When there are many problems or causes and you
    want to focus on the most significant.
  • When analyzing broad causes by looking at their
    specific components.
  • When communicating with others about your data.

Advantages of Pareto Charts
  • The main advantages of Pareto charts are that
    they are easy to understand as well as to
  • Many managers prefer to see an analysis that is
    easy to represent and understand and a Pareto
    chart is strong tool for that.

Disadvantages of Pareto Charts
  • Focusing on the Pareto chart alone may lead to
    the exclusion from further consideration of minor
    sources driving defects and non-conformances.
  • Another disadvantage of generating Pareto charts
    is that they cannot be used to calculate the
    average of the data, its variability or changes
    in the measured attribute over time. Without
    quantitative data it isn't possible to
    mathematically test the values or to determine
    whether or not a process can stay within a
    specification limit.

Fault Tree Analysis (FTA)
  • Fault tree analysis was first introduced by Bell
    Laboratories and is one of the most widely used
    methods in system reliability, maintainability
    and safety analysis.
  • It is a deductive procedure used to determine the
    various combinations of hardware and software
    failures and human errors that could cause
    undesired events (referred to as top events) at
    the system level.
  • The deductive analysis begins with a general
    conclusion, then attempts to determine the
    specific causes of the conclusion by constructing
    a logic diagram called a fault tree. This is also
    known as taking a top-down approach.

Fault Tree Analysis (continued)
  • The main purpose of the fault tree analysis is to
    help identify potential causes of system failures
    before the failures actually occur.
  • It can also be used to evaluate the probability
    of the top event using analytical or statistical
  • After completing an FTA, you can focus your
    efforts on improving system safety and

To do a comprehensive FTA, follow these steps
  • 1.Define the fault condition, and write down the
    top level failure.
  • 2.Using technical information and professional
    judgments, determine the possible reasons for the
    failure to occur. These are level two elements
    because they fall just below the top level
    failure in the tree.
  • 3.Continue to break down each element with
    additional gates to lower levels. Consider the
    relationships between the elements to help you
    decide whether to use an "and" or an "or" logic
  • 4.Finalize and review the complete diagram. The
    chain can only be terminated in a basic fault
    human, hardware or software.
  • 5. If possible, evaluate the probability of
    occurrence for each of the lowest level elements
    and calculate the statistical probabilities

A Simple Fault Tree Analysis
Symbols are used to represent various events and
describe relationships                  
And gate - represents a condition in which all the events shown below the gate (input gate) must be present for the event shown above the gate (output event) to occur. This means the output event will occur only if all of the input events exist simultaneously.
Or gate - represents a situation in which any of the events shown below the gate (input gate) will lead to the event shown above the gate (output event). The event will occur if only one or any combination of the input events exists.
Medical Device Fault Tree Analysis
Advantages of Fault Tree Analysis
  • FTA focuses on the judgment of experts from
    varied disciplines and provides a common language
    and perspective for the problem.
  • Both agreements and differences in opinion on the
    inputs and importance are accounted for in FTA.
  • Members are not likely to feel threatened, due to
    the focus on how the system operates, not
  • Graphic description clearly communicates the
    possible causes of failure.

Disadvantages of Fault Tree Analysis
  • FTA relies on several expert opinions and
    judgments at several stages. This makes it very
    prone to inaccuracy.
  • In large systems, computer algorithms are needed
    to accomplish the quantitative analysis.

Failure Modes and Effects Analysis (FMEA)
  • Begun in the 1940s by the United States military,
    FMEA was further developed by the aerospace and
    automotive industries.
  • FMEA is a step-by-step approach for identifying
    all possible failures
  • - in a design (design FMEA),
  • - in a manufacturing or assembly process
    (process FMEA),
  • - or in a final product or service (use FMEA).
  • Failures are any errors or defects, especially
    ones that affect the customer, and can be
    potential or actual.
  • Failure modes means the ways, or modes, in
    which something might fail.
  • Effects analysis refers to studying the
    consequences, or effects, of those failures.

Analyzing Failure Effects through FMEA
  • Failure can be represented by a Risk Priority
    Number (RPN).
  • Risk Priority Numbers (RPNs), can be ranked
    according to the following RPN (Potential
    Severity) x (Likelihood of Occurrence) x (Ability
    to Detect).
  • For all numerical weights, a common industry
    standard is to us a 1 to 5 scale. For likelihood
    of occurrence for example use 1 to represent
    practically impossible and 5 to indicate
    occurs frequently.
  • When applying FMEA, the high-priority
    failuresidentified by higher RPNsare examined
    first. For the failure, a root cause is
    identified and a corrective action is developed
    to eliminate the root cause .

Corrective Action for High Ranking Failures
  • Recommended action(s) to address potential
    failures that have a high RPN could include for
  • -specific inspection, testing or quality
  • -selection of different components or materials
  • -limiting the operating range or environmental
  • -redesign of the item to avoid the failure mode
  • -monitoring mechanisms
  • -performing preventative maintenance
  • -operator retraining
  • -inclusion of back-up systems or redundancy.
  • Assign responsibility and a target completion
    date for the above actions. This makes
    responsibility clear-cut and facilitates

Consequence x Likelihood Risk Matrix
Follow Up on Corrective Actions for High RFP
  • Indicate the action(s) taken for each high
    ranking failure (those having a high RPN).
  • After those actions have been taken, re-assign a
    new RPN based on the likelihood for the failure
    to occur again, and to what severity, and also as
    to how easy or harder it would be to detect
  • Determine with the new RPNs to what extent the
    failures are now under control. Are any further
    actions required?
  • Update the FMEA as to how the design, process, or
    final product/service has been improved.

Advantages of FMEA
  • Stimulates open communication of potential
    failures and their outcomes.
  • Requires that all known or suspected potential
    failures be considered.
  • Ranks failures according to risk.
  • Results in actions to reduce failure.
  • Results in actions to reduce risk.
  • Includes a follow up system and re-evaluation of
    potential failures that favors continual

Limitations of FMEA
  • FMEA may not be able to discover complex failure
    modes involving multiple failures or subsystems.
  • Without follow up sessions, the process will not
    be effective.
  • Follow up RPNs may be less instructive regarding
    improvement from severe failure since detection
    and occurrence can always be reduced but it is
    only in rare cases that severity ratings can be

Preventive Action and Risk Management
  • It involves the gathering of precursor data the
  • analysis of their risk.
  • Risk is a combination of likelihood of those or
    similar events happening at your site, how easy
    they are to detect, and what would be the
    consequences (as can be seen in the RPNs for

Preventive Action and Risk Management (continued)
  • Determine your risk tolerance (also called risk
  • Apply resources to lower unacceptable risks
  • ATM
  • accept if the risk is acceptable let it go
  • it later
  • transfer if the risk is unacceptable, the risk
  • perhaps be transferred to an insurance carrier
  • mitigate use change management principles to
    mitigate reoccurrence (the preventive action).
  • Refresh your data by adjusting the risk profile
    achieved after ATM and whether the risks are now
    within your risk tolerance.

Preventive Action and Risk Management (continued)
1. Gather and analyze precursor data.
2. Determine risk tolerance. Compare the risk
you are facing versus your risk tolerance.
4. Follow-up on the the appropriateness and
effectiveness of the actions taken.
3. Accept risk, transfer risk, or decrease risk
through preventive action.
Quality Data Sources

Communications Component Of Corrective And
Preventive Action (CAPA)
  • Communicate information about quality problems,
  • changes made, outcomes, and trends to those
    persons directly responsible and to the staff in
  • Forward information for management review
  • Work with staff and management to produce
    continuous quality improvement

CAPA Case Studies
  • Weak CA, Weak PA (Common)
  • Weak CA, Strong PA (Unusual)
  • Strong CA, Weak or Unlinked PA (Common)
  • Strong PA Linked to a Strong CA (Ideal)

Case Study No. 1
  • The company develops biopharmaceuticals
  • The company has a CAPA program
  • A review of existing internal and external audits
    reveal that
  • nonconformities are documented
  • corrections are proposed (a temporary or
    permanent change, repair, rework, or scrap)
  • corrections made are timely
  • but the same nonconformities seem to reoccur over
    and over again
  • customers are complaining

  • The current investigation indicates that
  • nonconformities are not adequately categorized
    and trended
  • the root causes of existing nonconformities are
    not adequately investigated or addressed
  • preventive actions are not sufficient to
    eliminate the reoccurrence of the nonconformity
  • discrepancy and CAPA procedures are not
    well-written or difficult to follow
  • the forms utilized dont follow the flow of the
  • the forms do not provide enough space for more
    than a brief entry
  • verbal decisions are not written down
  • responsible people are assigned but a timelines
    for the follow-ups is not given or is vague

The Solution
  • Revise all Quality Assurance Procedures to
    emphasize CAPA and to link discrepancy reporting
    and disposition to preventive action
  • Initiate a trending and root cause analysis
  • Present these programs to management and to the
  • Revise the nonconformity, CA, and PA forms
  • Conduct formal CAPA training
  • Reinforce CAPA awareness in verbal communications
  • Provide a Quality Update at the companys
  • staff meeting

The Results
  • Easier to follow quality procedures
  • More user-friendly forms
  • A better understanding of processes obtained
    through root cause analysis
  • More proactive thinking vs. reactive thinking
  • Fewer nonconformities
  • Less scrap and rework
  • Fewer customer complaints

Thank you