AGP HEALTH CARE (PVT) LTD.

STANDARD OPERATING PROCEDURE

TITLE: Root cause analysis S.O.P. NO.: QA013 REVISION: NIL REASON FOR REVISION: NEW DOCUMENT EFECTIVE DATE : 29-JUN-2011 TO BE REVIEWED ON: 29-JUN-2013

OBJECTIVE: This document is designed to assist the investigation team when undertaking root cause analysis of serious adverse events, complaints,deviations and non conforming products. Not all the techniques in this document need to be used in every investigation and further advice may be sought from the Q.A department as to the appropriateness of different techniques in each investigation. SCOPE:
This procedure encompasses

a. Resolution of customer complaints and returns. b. Disposition of non-conforming material c. Corrective action plans resulting from internal and external audits. d) Deviations handling

DEFINITIONS: Root Cause A root cause is a fundamental cause, which if resolved will eradicate, or significantly contribute to the resolution, of the identified problem (adverse incident). Root Cause Analysis Root Cause Analysis (RCA) is a structured investigation to identify the real cause(s) of a problem and the actions that are necessary to either eliminate or significantly reduce the risk

Brain Storming There are two main approaches to Brain Storming, Structured and Unstructured. Structured Brain Storming is where the facilitator asks each member of the group to contribute a suggestion or idea. This is a useful approach if some members of the group are very dominant, making it difficult for other members to contribute. Unstructured Brain Storming is a free for all. This enables spontaneitybut can lead to ideas being lost. The key to successful brainstorming is to focus on all members contributing their ideas, and not allowing any in-depth questioning or exploration until the process of brain storming is completed. The facilitator must also be careful to record ideas as they are spoken. Brain Writing This is a similar technique to Brain Storming but all members are given blank post it notes and contribute ideas anonymously. This technique is useful as participants are more willing and able to share their thoughts if given the privacy to do so. If this method is used it is important to set a time limit on the exercise and give participants enough space to enable privacy. Once the set time is up then the facilitator collects up the post it notes and notes all the ideas on the flip chart. If there are only a few issues raised then these can be explored using the Five Whys, Cause and Effect or Fishbone Diagram. However, if there are numerous issues raised the group must prioritise these and the most significant investigated. Nominal Group Technique This technique is a consensus-building tool. It can be used to assist the group in prioritising the issues they consider most significant in contributing to the event and therefore requiring root cause analysis. It can also be used to help the group decide the most fundamental root causes and to agree the priority recommendations arising from the investigation. It is important that all participants agree that they are bound by the results of this process. Firstly problems are identified using Brain Writing or Brain Storming technique. Then all ideas are transferred to a flip chart, with issues grouped together logically and duplicates removed. Each individual idea is then given a number. Each participant is given a rank chart and asked to choose 5 issues they feel are most important and prioritise them, with number 1 being the most important issue. Rank Chart:

Problem/Recommendation

Priority Rating

The facilitator then collects all the rank charts and totals up the points for each issue raised. The issues with the lowest scores form the list of prioritised issues for root cause analysis (or the prioritised list of recommendations). When using this technique to prioritise recommendations, actions requiring additional resources or senior management support are not necessarily more important than actions that the team themselves can implement.

The Five Whys This technique is best suited to non-complex problems and is a basic cause and effect technique. It can be very useful for department managers / service leads when exploring local incidents. It is important to remember that you should only undertake one cause and effect at a time. If this process identifies more and more problems it may be wise to transfer to the Fishbone Diagram Fishbone Diagram Technique The Fishbone Diagram technique is useful when needing to identify the influencing factors for a number of identified problemswithin a range of contributory factors. For example, the main problem to be investigated may be Theatre Delays and there may be several identified contributory factors within this. The Fishbone Diagram: For further information on Contributory Factors please see Appendix 4. The process should not only identify negative influences but positive also. A distinction should be made between the negative and positive factors by placing a + next the positive factors

Change Analysis Change analysis is used to identify the knock-on effects that everyday changes in the healthcare environment can bring. Firstly you map out the normal procedure that should occur without the adverse event occurring. Alongside this you map out what did actually happen resulting in the adverse event. Then you compare the two processes and identify the differences.

Then you identify whether the difference, or change, had a direct impact on the adverse event occurring. Once you have identified the changes that did impact then a further analysis can be undertaken as to why the changes occurred and if necessary barrier analysis can be undertaken Once this process has been carried out the investigator should analyse why these changes occurred. Barrier Analysis is a useful tool at this stage, along with the Five Whys and the Fishbone

PROCEDURAL DESCRIPTION:
Steps to root cause analysis a. Identify problem. b. Prepare investigation team. c. Select a tool for root cause analysis and determine the root cause. d.Determine corrective and preventive actions using CAPA procedure.

Root Cause Analysis Methods There are several techniques used in the process of root cause analysis:
i. Basic a. 5 Whys b. Brainstorming. c. Brain writing. d. Root cause analysis flow chart. ii. Intermediate a. Cause and effect Matrix b. Fishbone /Ishikawa/Cause and effect Diagram. c. Nominal group technique. d. Change analysis. iii. Advanced a. Statistics/ANOVA/SPC Chart b. FMEA. c. Management oversight risk ree (MORT)

-Change analysis - an investigation technique often used for problems or accidents. It is based on comparing a situation that does not exhibit the problem to one that does, in order to identify the changes or differences that might explain why the problem occurred.

3.1

Basic elements of root cause using Management Oversight Risk Tree (MORT) Approach Classification
Materials Defective raw material Wrong type for job Lack of raw material Man Power Inadequate capability Lack of Knowledge Lack of skill Stress Improper motivation Machine / Equipment Incorrect tool selection Poor maintenance or design Poor equipment or tool placement Defective equipment or tool Environment Disordered workplace Poor job design and/or layout of work Surfaces poorly maintained Inability to meet physical demands of the task Forces of nature Management Lack of management involvement Inattention to task Task hazards not dealt with properly Other (horseplay, inattention....) Stress demands Lack of Process Lack of Communication Methods No or poor procedures Practices are not the same as written procedures Poor communication Management system Training or education lacking Poor employee involvement Poor recognition of hazard Previously identified hazards were not eliminated