Root Cause Analysis the OOS report

 

1.0              OBJECTIVE:

To lay down the procedure for Root Cause Analysis.

2.0              SCOPE:

This sop is applicable for Root Cause Analysis the OOS report, self inspection observation, deviation, trend analysis, batch failure, annual product quality review, market complaint, quality audit report etc available to --------------

3.0              RESPONSIBILITY:

The responsibility of root cause analysis lies with Quality Assurance Executive and Quality Assurance Head.

4.0              ACCOUNTABILITY:                       

The Accountability of the sop is of concerned department /Quality Assurance Head.

5.0              PROCEDURE:          

5.1              Root Cause Analysis (RCA):

5.1.1        Definition: RCA is a problem solving technique for identifying the basic or causal factor(s) that underlie the occurrence or possible occurrence of an adverse event in a process similar to diagnosis of disease – with the goal always in mind of preventing recurrence. 

                                    RCA is done after an event has occurred. By gaining expertise in RCA, it can be used for preventing problems from occurring.

5.1.2        Following requisites for performing RCA:

5.1.2.1  Basic knowledge and experience of incidents and investigations.

5.1.2.2  Understanding of process and systems.

5.1.2.3  Gathering data from people, environment, material, measurement, machine, process etc.           

5.1.2.4  Analysis of data for all causal factors.

5.1.2.5  Use of appropriate RCA tools.

5.1.2.6  Determining all root causal factor.

5.1.2.7  CAPA, its implementation and continual improvement.

5.2              Tools to be used in RCA:

5.2.1        Why analysis: This tool is used in case of:

5.2.1.1  Incident involving human factor.

5.2.1.2  Obvious errors.

5.2.1.3  Stages:

5.2.1.3.1  Write down the specific problem.

5.2.1.3.2  Ask why the problem happened and write down the answer    below the problem.

5.2.1.3.3  If the answer written in first instance doesn’t identify the root cause of the problem, then again repeat the question why and again write down the answer.

5.2.1.3.4  Repeat this exercise until the investigation team is in agreement that the root cause is identified.

5.2.1.3.5  Specimen annexure for “5 why analysis” is given as Format   no F/QA-026-001.

5.2.1.3.6  This tool can be used individually or as a part of the fish bone diagram.

 

 

5.2.2        Fish bone Diagram:

5.2.2.1  The fish bone diagram is aimed at first generating possible root causes for the problem and then narrowing focus into the most probable cause for the problem.

5.2.2.2  This tool shall be used in case there is a need to display and explore many possible causes of a specific problem or condition.

5.2.2.3  Stages:

5.2.2.3.1        Define the problem.

5.2.2.3.2        Categories and brain storm the main causes (6Ms).

5.2.2.3.3        Identify the most likely cause/causes.

5.2.2.3.4        Priorities the causes based on severity i.e. the most probable cause.

5.2.2.3.5        CAPA

5.2.2.4  Pictorial representation of fish bone diagram of root cause analysis includes.

Head of fish: Problem or effect.

Bones of the fish: Causes

Example major causes: machine, materials, man, method, measurement, milieu/mother nature (Environment) etc. More groups can be added, if necessary.

Sub-branches: Sub causes.

5.2.2.5  Draw the Fishbone diagram/Ishikawa/cause and effect diagram as follow:

·         Write the problem on the far right side of diagram and draw a long horizontal arrow pointing towards it.

·         From the horizontal arrow, branch off main causes (6Ms) of this problem.

·         These 6 Ms are machine (technology), method (Process), material (includes raw material), man power (physical work), measurement (inspection) and milieu/mother nature (environment).

The above causes are the most significant causes, or potential causes of the problem. These will form the main branches from the “backbone arrow”. Any additional cause identified should be included as a separate category. If required.

·         From these continue to brainstorm in more detail, and explore why these factors may be problem. It is best to develop as many hypotheses as possible so that no potential root cause is overlooked.

·         In case of fish bone diagram, for defining sub causes, refer Format no. F/QA-026-02. In this annexure, 6 Ms causes are defined along with applicable questions. Each question need to answered in the form of ‘Yes’, ‘No’ and ‘Not applicable’. Any more questions apart from questions defined can be written in blank space provided under each cause. During identification of sub-causes, if the answer to any question in Format no. F/QA-026-02 reveal any abnormal finding, same should be evaluated further by performing “5-Why analysis” as per Format no. F/QA-026-01. These causes should be considered as “most likely causes”.

5.2.3        RCA team should ask a series of “why’s” repeat this with each major cause to      produce sub causes. Continue asking “why’s” and classify them on the diagram. If an idea fits on more than one branch place it on both. Be sure that the causes have a direct, logical relationship to the problem or effect stated at the head of the fish bone. Continue until potential root cause has been identified. A root cause is one that can explain the “effect” and if removed would eliminate the problem.

 

5.2.4        Example for causes/ reasons of non conformance that may be identified by per forming RCA are as follows:

5.2.4.1  ‘’Method/process’’ may include but not limited to, No or poor procedures, particles are not the same as written procedure, poorly communicated, not validated etc.

5.2.4.2  ‘’Measurement” may include but not limited to, procedures not followed, particles are not the same as written procedure, measuring technique not validated.

5.2.4.3  ‘’Environment / Mother Nature’’ may include but not limited to, improper maintenance of temperature, humidity conditions, and storage condition during transportation etc.

5.2.4.4  “Material” may include but not limited to, defective material, wrong material, contaminated material, mix-up in material, material from unapproved source, inappropriate sampling and testing, etc.

5.2.4.5  “Man” may include but not limited to, unauthorized to operate, unskilled and untrained, insufficient number of people, not following procedure, role and responsibility of people etc.

5.2.4.6  “Machine/Equipment” may include but not limited to, incorrect tool selection, poor maintenance or design, defective equipment or tool, out of calibration, inappropriate capacity, etc.

5.3              Summary report should be prepared as per Format no.: F/QA-026-03. In this annexure, the sub causes identified as per Format no.: F/QA-026-02 which is further to be subjected to 5-why analysis is to be considered as most likely causes (as per point 5.2.2.5).

5.4              Look for those items that appear in more than one category. This should be evaluated by RCA team member. These become the “most probable causes”

5.5              From those items identified as the “most probable causes” the team should reach a consensus using the team’s best collective judgment on listing those items being the “most Probable cause”.

5.6              During evaluation, team should priorities the causes as per the severity and same should be recorded in Format no.: F/QA-026-03. The most significant cause should be given the highest priority and accordingly recorded in Format no.: F/QA-026-03. For example in case the non conformity is due to 3 causes, the most significant cause should be given highest priority and numbered as 1 while the second most significant cause should be numbered as 2 and so on.

6.0              LIST OF ANNEXURE AND FORMATS:                            

Sr. No.	Title of Format	Format No.
01	5-Why Analysis	F / QA – 026– 01
02	Identification Of Sub -Cause	F / QA – 026– 02
03	Root Cause Analysis Summary Report	F / QA – 026 – 03