Presenting CAPA, Root Cause Analysis, and Risk Management Information

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CAPA, Root Cause Analysis, and Risk Management
Documented by Shubham Khandelwal
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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.

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CAPA is Part of the Seven Quality Subsystems
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• 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.
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Nonconformance Control Steps
1. Identify nonconforming items.
2. Move items away from work area.
3. Decide what should be done.
4. Take remedial action.
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Components Of Corrective Action

• Collect and analyze data to identify
  nonconforming
• product, incidents, concerns or other quality
• problems that would be worth the effort to
  correct
• Investigate and identify root cause
• Implement the correct solution
• Verify or validate effectiveness

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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.
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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
  obvious.
• 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.

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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
  occurred.
• 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
  teams.
• 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.

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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.

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Simple Fishbone DiagramBioburden Levels Out of
Specifications
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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.

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More Detailed Fishbone Diagram
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Simple Fishbone DiagramPatient Received
Incorrect Dose of Medication
Equipment needs not met
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Very Detailed Fishbone DiagramIncreased
Outpatient Department Waiting Time
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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.

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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.

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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).

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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.
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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.

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Advantages of Pareto Charts

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

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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.

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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.

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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
  methods.
• After completing an FTA, you can focus your
  efforts on improving system safety and
  reliability.

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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
  gate.
• 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

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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.
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Medical Device Fault Tree Analysis
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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
  personnel.
• Graphic description clearly communicates the
  possible causes of failure.

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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.

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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.

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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 followingRPN (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 .

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Corrective Action for High Ranking Failures

• Recommended action(s) to address potential
  failures that have a high RPN could include for
  example
• -specific inspection, testing or quality
  procedures
• -selection of different components or materials
  
• -limiting the operating range or environmental
  stresses
• -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
  tracking.

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Consequence x Likelihood Risk Matrix
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Follow Up on Corrective Actions for High RFP
Failures

• 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
  again.
• 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.

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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
  improvement.

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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
  reduced.

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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
  example).

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Preventive Action and Risk Management (continued)

• Determine your risk tolerance (also called risk
  appetite)
• Apply resources to lower unacceptable risks
  through
• ATM
• accept if the risk is acceptable let it go
  reevaluate
• it later
• transfer if the risk is unacceptable, the risk
  should
• 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.

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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.
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Quality Data Sources
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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
  general
• Forward information for management review
• Work with staff and management to produce
  continuous quality improvement

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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)

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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

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• 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
  procedure
• 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

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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
  program
• Present these programs to management and to the
  staff
• Revise the nonconformity, CA, and PA forms
• Conduct formal CAPA training
• Reinforce CAPA awareness in verbal communications
• Provide a Quality Update at the companys
  monthly
• staff meeting

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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

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Pre-CAPA
Post-CAPA
Post-CAPA
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Thank you