Root Cause Analysis (RCA)

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1.0 Purpose 
 
 The purpose of this procedure is to provide principles and tools for Root Cause Analysis
 (RCA). 
 
 2.0 Scope 
 
 Root cause analysis is a core building block to continuous improvement efforts made at Ion
 Nutritional Labs. It may be required in investigations for Quality Events or process
 
 improvements, including the following: 
 
 ° Non-conformances 
 
 e Deviations 
 
 ® Out of Specification / Out of Trend laboratory results 
 
 e Complaints 
 
 e Adverse Events 
 
 e Audit Findings 
 
 Risk Assessment / Risk Management 
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of all employees assigned to complete a root cause analysis to
 
 follow this procedure. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 Root Cause Analysis (RCA) QS-111 1 Page 2 of 9 
 
 3.2 It is the responsibility of Quality to keep this procedure aligned with current practices.
 
 4.0 Definitions 
 
 4.1 Cause — the reason something happened. Causes of failure have sub-classifications as
 
 direct, indirect, potential, and /or root causes 
 
 4.2 Direct Cause — A cause clearly linked to the problem of failure 
 
 4.3 Indirect Cause — A cause that creates a circumstance or action that ultimately causes
 the problem or failure 
 
 4.4 Potential Cause — A cause that could be a direct or indirect cause to the problem or
 failure, but either was not or is not proven as a cause in the specific instance
 
 4.5 RCA — Root Cause Analysis; A collective term that describes a wide range of
 approaches, tools, and techniques used to uncover causes of problems or failures and
 
 then analysis of those causes to determine the root cause(s) 
 
 4.6 Root Cause —The core or fundamental issue that sets in motion the entire cause-and-
 effect reaction that ultimately leads to the problem(s) or failure(s). Strict definitions of
 
 root cause restrict RCA to only one root cause; however, there are often multiple causes
 to a problem or failure. The root cause is the largest contributor and other causes are
 
 secondary. For the purpose of RCA, Ion Labs allows more than one cause labeled as a
 root cause as long as each root cause is a significant contributor to the problem or
 
 failure. 
 
 4.7 Quality Event — The issuance of an event number for a quality system subject to SOP
 QS-112 and as defined in the scope of specific SOPs associated with that system
 
 4.8 cGMP — Current Good Manufacturing Practices 
 
 4.9 CAPA -— Corrective and Preventative Action as defined in SOP QS-108
 
 
 

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 Standard Operating Procedure SOP No Rev 
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 4.10 OOS — Out of Specification 
 
 4.11 SME — Subject Matter Expert 
 
 5.0 References 
 
 5.1 QS-111-F1, Form, Root Cause Analysis Form 
 
 D2 C-105, SOP, Protocol and Report Documentation Requirements 
 
 5.3 QS-114,SOP, Quality Risk Management 
 
 5.4 QS-112, SOP, Core Quality Systems and Quality Events 
 
 5.5 C-201, SOP, Deviation and Investigation Procedure 
 
 5.6 C-501, SOP, Document Control 
 
 5.7 C-502, SOP, Record Storage, Retention, and Destruction 
 
 5.8 D-105, SOP, Out of Specification / Out of Trend Investigation 
 
 ee QS-101, SOP, Complaints 
 
 5.10 QS-102, SOP, Adverse Events 
 
 5.11 QS-108, SOP, Corrective and Preventative Action (CAPA) 
 
 6.0 Procedure 
 
 6.1 General Principles 
 
 6.1.1 Base RCA on scientific knowledge and the protection of the patient / customer.
 
 6.1.2 Adjust the level of effort, formality, and documentation of the RCA to be
 commensurate with the level of risk. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
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 6.2 RCA Documentation 
 
 6.2.1 For simple RCA, document the risk assessment directly in the documentation
 
 associated with the problem or failure. 
 
 6.2.2 For complex RCA, document the RCA in a report (see SOP C-105 Protocol and
 
 Report Documentation Requirements for report documentation). 
 
 6.2.3 Use form QS-111-F1 Root Cause Analysis Form to document all other RCA.
 
 6.3 RCA Problem / Failure Sources 
 
 6.3.1 Initiate RCA in response to exception data (ie. Quality Events that may
 
 negatively affect the quality of components, materials, products, procedures, or
 
 systems). These sources include, but are not limited to: 
 
 6.3.1.1 Complaints - SOP QS-101 
 
 6.3.1.2 Deviations — SOP C-201 
 
 6.3.1.3 OOS —SOP D-105 
 
 6.3.1.4 Audits or FDA Inspections 
 
 6.3.1.5 Product rejections / nonconformities 
 
 6.3.1.6 Recalls 
 
 6.3.2 Initiate RCA in response to non-exception data such as: 
 
 6.3.2.1 Data trending and holistic data reviews 
 
 6.3.2.2 Continuous improvement projects 
 
 6.3.2.3 Industry and regulatory surveillance 
 
 
 

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 6.4 RCA Steps 
 
 6.4.1 Define the problem. The source typically defines the problem as well. If
 
 necessary, clarify the problem such that the problem or failure to analyze s clear.
 
 6.4.2 Collect data to better understand the problem. Analyze the situation fully before
 
 moving on to identify contributing factors. Be cautious about making decisions
 on assumptions and theories. If possible, verify assumptions and theories with
 
 facts. Use the RCA tools as applicable. 
 
 6.4.3 Identify contributing factors. Identify as many potential causes for the problem
 as possible. Use the RCA tools in Section 6.5 as applicable. 
 
 6.4.4 Identify root cause(s). 
 
 6.4.5 Identify CAPA as applicable. 
 
 6.5 RCA Tools 
 
 6.5.1 5 Whys — the 5 whys method is a powerful RCA tool. This process must include
 
 individuals with practical experience with the system or process that is the
 source of the RCA investigation. The process simply asks the question “why” at
 
 least five (5) time. Each additional question is framed to ask why the previous
 why answer is true. See example in Attachment 1. 
 
 6.5.1.1 In general, ask “why” as many times as it takes to get to a root cause.
 
 6.5.1.2. Do not ask why too many times such that unreasonable answers result.
 
 Asking why 5 times is an arbitrary number. 
 
 6.5.1.3. Search for factual answers, not opinions or guesses.
 
 6.5.1.4 There may be more than one cause. In these cases, the 5 whys analysis
 
 may look more like a matrix with different branches. 
 
 
 

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 6.5.1.5 Ifapplicable, use this tool in combination with a Fish Bone Diagram.
 
 6.5.2 Fish Bone Diagram — this RCA tool is also known as “The Cause and Effect”
 
 diagram. The diagram visually displays potential causes for a specific problem
 or effect. To construct a fishbone, start with stating the problem in the form ofa
 
 question (i.e. “Why did X happen”) and place it in a box at the head of the
 fishbone. See example in Attachment 2. The rest of the diagram consists of one
 
 line drawn across the page attached the problem statement and several lines, or
 
 “bones” coming vertically from the main line. The branches are labeled with
 different categories. The categories you use are up to you, but the following are
 
 good examples for manufacturing processes: 
 
 6.5.2.1 Machines (Equipment) 
 
 6.5.2.2. Methods (SOPs, Policies, Procedures) 
 
 6.5.2.3 Materials (Raw Materials 
 
 6.5.2.4 Measurements 
 
 6.5.2.5 Mother Nature (Environment) 
 
 6.5.2.6 Manpower (People) 
 
 6.5.3 Review — review of documentation and data records associated with a problem
 
 or failure may provide insight to the cause. 
 
 6.5.4 Interview — interviews of operators or individuals that observed or participated
 in the events that led to the problem or failure are often valuable. Additionally,
 
 interviewees that are Subject Matter Experts (SME) on a related subject may
 have insight into causes of the problem/ failure. 
 
 
 

[SOP 

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 6.5.5 Search — research on a subject related to the problem is similar to interviewing
 an SME. Solutions to the problem may already be well documented and could
 
 be referenced. 
 
 6.5.6 Other — root cause analysis is a common process to many industries. There are a
 
 number of good RCA tools available and many good training courses. Any tool
 or process that helps improve product quality and compliance is allowed.
 
 6.6 Documentation Maintenance 
 
 6.6.1 All completed RCA forms will be maintained as outlined in SOP C-501
 
 Document Control and SOP C-502 Record Storage, Retention, and Destruction.
 
 6.6.2 When applicable, completed RCA forms will be filed with the Quality Event
 documentation to which it pertains (i.e. deviation, OOS, complaint).
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 01/14/20 | New. N/A K. Burris ; OONSiA8 A Sc d h d e d s u e l ct e i d o n r e f v o i r e w d : o c u u p m d e at n e t l m o a g i o n t a e n n d a n f c o e r . m at. Revise responsibilities. CO2 9 a 4 - . O 210) Ae BUBU ; S | - | - |

 8.0 Attachments 
 
 8.1 Attachment 1 — 5 Whys Example 
 8.2 Attachment 2 — Fish Bone Diagram Example 
 
 
 

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 Attachment 1 —5 Whys Example 
 
 Problem 
 Our client is refusing to pay for leaflets we printed for him
 
 The delivery was late, so the = a sd ee 
 leaflets couldn't be used Why? Reason 2 Why? Reason 1 
 | 
 ¢ 
 
 Why? | Reseee 2 | 
 The Job took longer than 
 we expected : | 
 
 < $ 
 
 We ran out of printer ink Why? | Reason2 — | Reason1 
 
 = z < ) = Fto 4 nb ~ 
 
 The ink was all used ona | Reason 1 | | Reason 1 | | Reason 2 | 
 large, last-minute order ! 
 
 & 
 
 We didn’t have enough Ink in 
 stock, and couldn't order new 
 supplies in time 
 
 Counter-measure 
 
 Find an Ink suppller who can deliver at short notice, so that we can continue to minimize
 inventory, reduce waste, and respond to customer demand. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 Root Cause Analysis (RCA) QS-111 1 | Page %of9 
 
 Attachment 2 — Fish Bone Diagram Example 
 
 CAUSE 4 EFFECT 
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 Training Size of Ball Aiming Point I 
 Consistency Lopsidedness \ Bend Knees = ' 
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 Concentration \ Grain/Feel (Grip) \ Hand Position \ 
 Motivation Air Pressure Follow-Through hy 
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 Wind Gusts/Sun/Rain Rim Alignment / 
 - Open Air Environment 
 Rim Height 
 Rim “pl- Taighytne”ss / 
 Backboard Stability / 
 
 SASALIEY 
 Hoop & Backboard 
 
 
 

[SOP 

 ION 
 Root Cause Analysis Form 
 NLuatbrsi tional Form: QS-111-F1 CCR No. CC-23-0470 Revision: 1 
 
 Root Cause Analysis (RCA) — Title / Description / Background 
 
 Source / Reference 
 (i.e. DEV #, INV#, Etc.) 
 Note: For complex RCA, write a report instead of using this form (see SOP C-105 for reports). For simple RCA, document the RCA
 directly in the source instead of using this form. Adjust the level of effort, formality, and documentation to the level of risk.
 RCA- Use tools discussed in SOP QS-111 to identify potential causes and list viable causes in the RCA summary table
 on this form. Check all RCA tools used as applicable form the list below 
 5 Whys Fish Bone Review Records (specify) 
 
 Interview Observers / Operators (specify): 
 Interview Subject Matter Experts (specify): 
 
 Search Resources (specify): 
 Other (specify): 
 
 RCA Summary — Evaluate each listed cause and indicate the cause type (check all that apply). List CAPA as applicable.
 Note: A “Potential Cause” cause type indicates that this cause did not contribute in this instance.
 Cause Cause Type Action Plan 
 0 N/A or 0 Cause (specify) C) Potential Cause Cl CAPA 
 C) Direct Cause O None 
 C Indirect Cause 
 C Root Cause 
 OC N/A or O Cause (specify) O Potential Cause O CAPA 
 C] Direct Cause O Accept 
 C Indirect Cause 
 OC Root Cause 
 N/A or C0 Cause (specify) C Potential Cause C1 CAPA 
 ZC Direct Cause O Accept 
 C) Indirect Cause 
 C Root Cause 
 1 N/A or CO Cause (specify) C Potential Cause O CAPA 
 CO Direct Cause CO Accept 
 OC Indirect Cause 
 OC Root Cause 
 C N/A or O Cause (specify) C Potential Cause OO CAPA 
 CO] Direct Cause 0 Accept 
 O Indirect Cause 
 C1 Root Cause 
 Approval Signatures 
 Name Title Signature Date 
 Completed By: 
 (Initiator) 
 Approved By: 
 (Quality)