1. Root Cause Analysis (RCA) in Corrective Actions
Asian Forensic Sciences Network
Quality Assurance & Standards Forum
26 May 2011
Root Cause Analysis (RCA) in Corrective Actions
Dr Michael Tay
Forensic Science Division
Health Sciences Authority

2. ISO Requirement
Root cause analysis is a requirement under section “4.11 Corrective action” of ISO17025
Section deals with “Cause analysis”. “The procedure for corrective action shall start with an investigation to determine the root cause(s) of the problem.”
Formal documented (written) procedures & policies are required.
Note: “Cause analysis is the key and sometimes the most difficult part in the corrective action procedure.”
Why did it go wrong” instead of just “What went wrong?” Often, non-conformance is merely the symptom of an underlying problem.
By looking deeper into the quality system and identifying the root cause and implementing the appropriate corrective action, the recurrence of a similar non-conformance will be reduced.

3. Non-conformity, near-miss & close call
Non-conformity: Non-fulfillment of a specified requirement.
Similar terms: non-conformance, deficiency, accident, incident, event, adverse event, error, occurrence.
Near-miss: any process variation that did not affect an outcome, but for which a recurrence carries a significant chance of a serious adverse outcome. Similar terms: sentinel event, near-miss incident.
Close call: Event or situation that could have resulted in an adverse event, accident, injury, miscarriage of justice, etc, but did not, either by chance or through timely intervention.
Compare errors detected before & after issue of forensic report.

4. Correction Don’t confuse correction with corrective action.
Correction is an action to eliminate a detected non-conformity.
Remedial action that addresses the event and its consequences.

5. Corrective action
Action taken to eliminate the cause of a detected non-conformity or other undesirable situation. The damage is done. Corrective action prevents recurrence.
Corrective action has two components:
remedial action (i.e. correction) and
root cause analysis.
Corrective actions learn from the event and avoid its recurrence. They should be feasible, appropriate, clearly state any new risks, and allow the primary objectives of the work to be met.

6. Corrective actions are of 2 kinds
On-the-spot or immediate corrective actions to correct or repair non-conforming data, reporting or equipment.
actions routinely made by analysts, technicians and supervisors.
deals with the immediate problem.
Long-term corrective action to eliminate causes of non-conformance or a complex deficiency normally identified by audits.

7. Preventive action
Preventive action: taken to eliminate the cause of a potential non-conformity or other potentially undesirable situation. Prevent occurrence.
Preventive action has 2 components:
risk assessment and
continuous improvement.

8. Root cause
the basic (fundamental) or underlying cause of an event which can be reasonably identified that management has control to fix.
Eliminating the root cause should prevent the recurrence or greatly reduce the probability of recurrence of the event.

9. Other causes
Contributing cause: a cause that contributed to the occurrence, but by itself would not have caused the occurrence.
Direct cause or proximate cause: event that is closest or immediately responsible for producing the non-conformity. Often wrongly thought to be the real reason or root cause.

10. Identification of quality problems in a forensic lab
Investigation of suspected quality problems is initiated as a result of:
quality control criteria being exceeded,
specified requirements not being met,
Internal or external audit findings indicating systematic problems,
management reviews or
feedback or complaints from customers and staff.
The number of errors an agency detects may depend on how hard it looks for errors.
Reporting, documentation, investigation, corrective action and tracking of errors should be mandatory.

11. Common non-conformities
Sample mix-up
Contamination
Loss of sample integrity
Broken chain of custody
Loss of exhibit
Incorrect calibration
Departure from written SOPs
Calculation errors or transcription errors
Wrong interpretation of data and incorrect conclusion
Wrong proficiency test results

12. Goals of Root Cause Analysis
RCA is a problem-solving and improvement technique.
Design processes that will prevent errors (“mistake-proofing”) through:
standardization and
redundancy
Create systems to make errors more visible, and detect errors as soon as they occur
Implement processes to mitigate the adverse effect of errors

13. Primary focus of RCA Fixing the system, not the symptoms.
Looks beyond the immediate result and identifies the chain of events or contributing factors which led to the error.
Uses a structured and process-focused framework to analyse errors: to identify what happened, why it occurred, and what can be done to prevent recurrence.
Process looks at both active errors (acts or omissions by people performing the forensic examinations) and latent errors (inordinate time pressures, inadequate staff, equipment failures) and avoids the tendency to assign individual blame.

14. RCA is a challenging exercise
“Root cause analysis is the most challenging aspect of the corrective action process and should be used as a tool for continuous improvement, which may reduce or eliminate the likelihood of future deficiencies.”
“Understanding why an event occurred is the key to developing effective corrective actions. In some cases, the root cause is singular and easily discerned solutions; in most cases it is not, and there may be multiple root causes. Because of this, there is no single “recipe”.” A2LA (2010).

15. Frustrations in RCA
Identifying the root cause can be confusing, complex and frustrating.
“So what was the root cause?”
“No root cause identified”
“Multiple potential root causes”
“Equipment fault”
“Human error”
“Freak weather”
“External factors (beyond our control)”
What effective recommendations can be proposed for such vague root causes?

16. Root causes are not …
Statements of a root cause which are essentially a restatement of the deficiency (i.e. non-conformity) provide no new information beyond the deficiency and are of little benefit to you and are not considered to be an acceptable response. The American Association for Laboratory Accreditation (2010).

17. Examples of restatements
Finding: The lab has no clear written procedures on the electronic transmission of results.
Root cause: No procedure in current Quality Manual on electronic transmission of results.
Finding: The laboratory did not address transport and storage of measuring equipment in its procedures.
Root cause: Transport and storage of measuring equipment not addressed in lab manuals.
Finding: LIMS screen on labtop #4 was in the logged in mode without any password protection. Lab staff explained that this is a common terminal that is always logged on.
Root cause: Delayed logging out of LIMS after use.

18. Does every non-conformity require a full scale RCA?
Do we need to set up a team and spend many man-hours brainstorming, interviewing staff, analysing, flowcharting, etc?
Finding: Pipettes send out for external calibration is not checked by the lab before use upon return to lab.
Root cause: No procedure for performance check on pipettes in current Method Manual.

19. Graded approach
Corrective action should be to a degree appropriate to the magnitude and the risk of the problem.
The levels of analyses, documentation and actions used to comply with requirements should commensurate with the adverse impact of the problem.

20. Don’t go for quick temporary fixes
Most of the time, correcting the detected non-conformity becomes priority. This action results only in correction.
Most corrective action processes look only at the short term – the quick fix. These “solutions” do not last, resulting in repeat findings.
Repeat finding: a finding (deficiency) previously observed in an evaluation, is again observed in a subsequent evaluation in the same or other areas of the laboratory.
Repeat findings are a symptom of quality system failure.
Fixing the same problem time after time means a deeper underlying root cause has not been dealt with.

21. Dos and Don’ts in RCA Take a positive approach.
Root cause analysis should be led by an expert with no direct or indirect interest in the outcome of the root cause analysis.
Keep good records of all problems, investigations and actions taken.
Start ASAP as memories fade, and traceability decreases.
Monitor/track trends in errors.
Avoid a culture of name, blame and shame.
Sometimes RCA fails to identify true root causes to avoid embarrassing management personnel.

22. Categories of causes
Manpower (staff): inadequate qualifications, skills, training, worker fatigue, illness, hunger, taking unnecessary risks, inadequate staffing, character and integrity problems
Communication & coordination: inadequate supervision, language barrier, misunderstanding, misinterpretation, unclear instructions, poor communication, teamwork problems.
Methods, procedures & policies: inconsistent, unclear, insufficient or non-existent procedures, possible errors not identified, outdated methods, lack of preventive measures, no safety net, no code of conduct and ethics
Organisational: culture, structure, management decisions
Work environment: workflow, location, lack of space, over-crowding, lighting, non-conducive or distracting environment,
Equipment, materials & supplies: inadequate equipment, wrong tools, expired unstable standards and reagents, calibration, malfunctioning equipment, breakdown, using lowest-cost equipment
Sample: Improper collection, storage, handling or preparation, challenging sample, sample specifications, beyond lab’s technical capability
Customer: inordinate expectations, requirements, tough deadlines

23. Corrective action process
Closed-loop process that includes:
Detection and identification of a non-conformity (NC)
Investigation: understand and analyse the NC. Examine the extent and impact of the problem): Look for similarity with other events. Document findings and conclusions
Identify all possible causes and determine the root cause so as to control and prevent recurrence of the problem.

24. Corrective action process
Propose corrective action that addresses the root cause – Develop solutions. How can that be prevented?
Examine and accept the corrective action -Assess feasibility from resource and economics’ view point (cost-benefit)
Implement the corrective action - Assign someone the responsibility to implement the solution.
Monitor and verify its effectiveness - Assign someone else to verify. Loop back to (3) root cause determination if similar NC is detected again, and propose and implement a different or modified corrective action.

25. Questions to ask in RCA What could have happened?
After collecting data, generate hypotheses.
Consider less obvious and possible but unlikely hypotheses also.
Hypotheses are proved or disproved by factual evidence or expert knowledge.
Why did this occur?
What contributed to the event?
How did this happen?
Has this occurred before?
Why did the previous solution fail?
Which of the foundation systems is affected?

26. Toyota’s 5 Whys technique
Also known as “Why-why analysis”.
Simple but effective technique to help understand the reasons for problems occurring.
Steps
State the problem and ask why the problem occurred.
Once the reason for the problem occurring is identified, the question “Why?” is again, and so on.
Continue asking “Why?” until either
a cause seems sufficiently self-contained to be addressed by itself or
no more answers to the question “Why?” can be generated.

27. Example of the 5 Whys technique
The daily QC result for the quantitation of an analyte was outside the tolerance limits. When a fresh calibration standard of the analyte was used, the results were within the tolerance. A similar situation occurred a week later was resolved in the same manner. The same problem recurred a week later. This issue was surfaced to the supervisor.
First Why: Why was the QC result an outlier?
Reason: The prepared QC standard did not have the correct analyte concentration.
Second Why: Why didn’t the prepared QC standard have the correct analyte concentration?
Reason: Perhaps the QC analyte in the vial was unstable and degraded after being opened.

28. Use of the 5 Whys technique
Third Why: Why did the QC analyte in the vial degrade after being opened?
Reason: Because the QC standard was not maintained at the prescribed temperature during storage.
Fourth Why: Why was the QC standard vial not maintained at the prescribed temperature?
Reason: Because the QC standard vial was stored with other chemicals and reagents in the refrigerator whose door was frequently opened every day for the search, removal and storage of other items.
Fifth Why: Why was the QC standard stored with these other chemicals and reagents?
Reason: Because the lab does not have a second cold storage area.

29. Example of the 5 Whys technique
Root cause: Lack of a dedicated refrigerator to ensure stability of the opened standard.
Proposed corrective action: The lab will purchase a small refrigerator and store the opened standard in this dedicated refrigerator with no other reagents stored in it. This standard will be taken out only once a day from the refrigerator to take out the required amount of standard from the vial.
Verifying the effectiveness of the corrective action: The QC results for the analyte were monitored and found to be satisfactory over the 15 days that the QC standard lasted.
Conclusion: The correct root cause was identified.

30. Cause-effect diagrams
Non-compliance
Materials
Methods
Money
Machinery
Manpower
Cause #1
Cause #2
Cause #3
Fish-bone or Ishikawa diagrams
Cause-effect diagrams determine root causes by asking the what, when, where, how and why questions, and adding possible answers in an explicit way.
Identify areas where further data is needed.
Widely used in improvement programs.

31. Cause-effect diagrams
Steps
State the non-compliance (problem) in the fish-head or effect box on the right.
Identify the main categories for possible causes of the problem: machinery (equipment), methods, manpower, etc.
Use systematic fact-finding and group discussion to generate possible causes under these categories. Anything that may result in the effect being considered should be put down as a potential cause.
Record all potential causes on the diagram under each category, and discuss each item in order to combine and clarify causes.
Circle particularly significant clauses and drill down to the root cause(s).

32. Conclusions Root cause analysis is a requirement under ISO 17025.
Corrective action must start with an investigation into the root causes of the problem.
Root cause analysis eliminates the underlying cause of a non-conformity rather than merely address the symptoms of the problem.
Without dealing with the root cause, the corrective action will be ineffective and the problem will recur.
Useful RCA tools include the 5 Whys analysis and the Cause-Effect diagram.
RCA is a challenging exercise, but we get better with practice.
The tracking of non-conformities and root causes allows management to pinpoint fundamental weaknesses in the quality system tool and to address them.