Root cause analysis (RCA) is a true multidisciplinary process. Good RCA requires that technical and human aspects of process failures are evaluated conscientiously.
The application of RCA should be consistently applied in almost every interaction you have in the quality realm. In meetings, you should apply these methods in determining if you are hearing a perspective or hearing fact. In conversations about investigations you need to communicate what your intent is; to solve the problem so it does not happen again. You are trying to make the system better for them. Its the process, not the people*.
With consistency every interaction will become more focused and personnel will become more compliant. Everyone who has gone through RCA with you, or knows of your reputation will know that you will not be satisfied with the established narrative. You ask questions. And you will keep asking if it does not make sense. You are going to ask for documentation. You are going to ask for objective evidence. You are going to talk to everyone you can. You may ask for testing of the product. You will pull electronic files and evaluate machinery. You check timelines.
This does not mean that each person involved is going to lie or not be forthcoming, it is human nature to paint the issue in the best possible light, or to state that they do not know what happened even if they do because of the perception that blame will be assigned. No one wants to get anyone into trouble including themselves.
*Get this through your head now: You are not looking to fire someone or to have them fired. If you are please recuse yourself. Otherwise there may be an investigation of another type into you and your motivations with people who are motivated to find blames and reduce personnel risk.. I caveat this statement here as you should to those under investigation: If there is a trend of making the same mistake (not learning from past mistakes through good RCA), if there is a coverup, if there is someone who has been hurt because you knowingly did not do something you knew you had to do (trained on a procedure), if you don't care about what happened, if you do not evaluate potential for accountability, there may be no way that you can end up turned loose on the process you were trained to do again. That does not mean fired, it means scrutiny as to what processes can be completed with that mindset. There may be very few of those seats on the bus.
In short: If you were a bad actor we will find out. If you were conscientiously executing the process and something went wrong, they should have NOTHING to worry about.
I use this as a philosophy about the investigation of human based processes. If the person involved can articulate the circumstances, the headspace, the objective evidence, the status of equipment, the information they were provided, and any other information borne out by the investigation and I can understand the result of the process including how they could have made those decisions knowing what they knew and when, then it is a process issue. This does not include excusing poor judgment. This does not excuse doing what they were told. But it does take into account human limitations:
- Was this at the beginning or end of the shift?
- Have they been moved from day to nights or swings?
- How many hours have they been working this week?
- How long have they been doing this process?
- When was the last time this equipment was serviced?
- Were they set up for success?
- What work constraints are they under?
This post is not about excuses. This is about objectively looking at how the process failed and human factors impact human operated processes. This isn't about finding a smoking gun.
So with all of this narrative, I now can discuss what I think root cause analysis is
Root Cause Analysis (RCA) is a structured investigation that aims to identify the true cause of a problem and the actions necessary to eliminate it. RCA helps understand which aspects of a problem need to be resolved and describes the real nature of the problem and its consequences.
The following workflow can be used as a tool to help with this process. It is especially useful when applied to the procedures used to resolve deviations and to design corrective and preventative actions. The user may employ any other techniques, alone or in conjunction with this procedure, to resolve nonconformances and should always be aware that there may be more than one cause/condition that leads to an unexpected event. The attached spreadsheet can be used to document the RCA process.
The RCA process is described in three parts:
1) A detailed description of the symptoms of the nonconforming event, its source and its criticality.
2) A determination of the probable causal factors/conditions and selection of the likely root cause(s).
3) A determination and implementation of corrective action(s) needed to eliminate the cause and an assessment of the efficacy of those actions.
My general workflow:
0). Investigation and Collection of Evidence
As discussed above, you need to come up with an investigation technique. Your technique should be adaptable to the situation. If you have a batch that a simple question needs to be answered for release would require a different tact (maybe?) than a serious adverse event. I can blather about investigation technique all day (...no really, you don't say).
1) Event Symptoms
a) Description
i) Concisely state the objective evidence that supports the existence of an undesirable event. A thorough understanding of the process is required to effectively complete this description.
ii) Describe what actually happened (What, When, Where, Who, Why). Flow charts and other visual aids should be used as needed and included in the RCA summary package.
iii) Include a description of what was expected to occur. This information may exist in various forms:
(1) Written (e.g. internal/external specifications, PO, regulatory standards).
(2) Verbal (e.g. something agreed upon but is not in writing).
(3) Assumptions (e.g. common sense, public opinion generally accepted practices).
iv) Describe the discrepancy between the expectations and what actually happened.
b) Information Source
i) List the source of the information about the event (e.g. complaints, information from personnel, literature, business journals, adverse events records, audits).
c) Criticality
i) Assess the criticality of the events. Identify what really are the most troublesome symptoms of the event.
ii) Assign a criticality level (e.g. High/Med; Low; 1, 3, 5; etc.). Use this assignment to determine the appropriate resources/time to commit to the resolution of the problem.
iii) Include a justification for the criticality assignment.
2) Possible Causal Factors/Conditions
a) Description
i) Generate a list of factors that may have caused the undesirable event. Consider any associated conditions that are required in order to make the causal factor assignment.
ii) Answer the question “What Caused the Change And What Condition Existed That Allowed This Change To Have an Impact On The Process?”
iii) Analyze any changes observed in the process (random, non-random). Consider the impact of the following groups/causes on the event:
(1) People – Poor Work Practices, Inadequate Training/Education, Ineffectively Defined Job Descriptions, Poorly Designed Schedules, Ineffective Management.
(2) Materials – Incorrect Materials, Materials Out-of-Specification/Expired, Unqualified Vendor.
(3) Machine/Instruments –Ineffective Maintenance, Calibration Expired, Poor/Expired Warranties, Complex or Dangerous Man/Machine Interface.
(4) Methods – Inadequate SOP Quality, Ineffective Training Quality, Incorrect Method Used, Method Used Incorrectly, Method Not Validated, Inferior Reagents Purchased/Used.
(5) Environment – Temperature Excursions, Exposed Hazards, Noise Levels too high to Concentrate, Crowded Work Area.
(6) Process Controls – Ineffectively Designed, Process Changed, Analytical Methods Changed, Lack of Validation, Incorrect Critical Control Points Identified.
iv) Determine cause and effect relationships. Include the “5-Whys” approach.
v) Chart data as needed to improve understanding.
vi) Create a hypothesis on the root cause and justify.
b) Likelihood
i) Assign a probability that the identified causal factor and condition represent a possible root cause (High/Med/Low; 1, 3, 5; etc.).
c) Information
i) Detail all information that supports the assignment of a potential root cause and any tests or further information that are needed to verify the description.
d) Obtain consensus on the probable root cause.
3) Possible Corrective Actions
a) Description
i) Describe possible actions that could be used to correct the root cause.
ii) Ensure that these actions can generate measureable outcomes.
b) Risks
i) Describe risks associated with implementing the corrective actions.
ii) Assign a probability that the risk would occur (High/Med/Low; 1, 3, 5; etc.).
iii) Detail actions that could be used to mitigate the risk and assess the degree of mitigation (i.e. High reduced to medium, or 5 reduced to 1).
iv) Determine if the mitigated risk level is acceptable.
c) Measure Effectiveness
i) Identify test methods and acceptance criteria that would provide objective evidence for effectiveness of the corrective actions. Address any required timelines for completion of the corrective actions.
ii) Documents results as they become available and present them for discussion.
iii) Document conclusions derived from the presented results.
iv) Obtain consensus on the efficacy of the corrective actions and determine changes required to any processes required as a result of these conclusions.
4) Closure
a) Obtain required signature approvals for completion of the RCA process.
b) Include this information in any associated process documents (CAPA, Deviations and Investigations, Audit Responses, etc.)
Okay, so you made it through this post. You can make it through an RCA. Good luck. Hit me up if you ever need to talk about something unique or challenging. I would like that. Yes I am that weird.
Good Background:
https://en.wikipedia.org/wiki/Root_cause_analysis