Risk analysis and control nhsiq 2014
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Risk analysis and control FMEA: Failure Mode and Effects Analysis (FMEA) is often the first step of a system reliability study. It involves reviewing as many components, assemblies, processes and subsystems as possible to identify failure modes, and their causes and effects. For each component, the failure modes and their resulting effects on the rest of the system are recorded in a specific FMEA worksheet. - more at http://www.nhsiq.nhs.uk/improvement-programmes/patient-safety/learning-and-resources.aspx
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Risk analysis and control nhsiq 2014
- 1. © NHS Improving Quality 2014 Risk Analysis and Control Patient Safety Team
- 2. © NHS Improving Quality 2014 “Unfortunately, I think historically the way a lot of issues have been identified has been in a reactive fashion, after something has occurred.” (Duke CEO)
- 3. © NHS Improving Quality 2014 Safety Assessment • Enhancing the reliability of processes usually forms part of a detailed safety assessment • The aim of Safety Assessment (SA) is the identification and control of risks • SA forms part of an organisational Safety Management System (SMS) • The aim of the SMS is to identify and control known hazards (SA), to monitor safety performance, to learn safety lessons and to identify novel risks.
- 4. © NHS Improving Quality 2014 Scope of Safety Management System G: System is safe Risk from hazards is reduced to an acceptable level Risk control interventions are implemented and operational Novel risks are identified and assessed FMEA Proposed intervention Incident reporting Risk monitoring 0 10 20 30 40 50 60 Jan Feb Mar Apr May June Dose Frequency Drug
- 5. © NHS Improving Quality 2014 Resilience G: System is safe Risk from hazards is reduced to an acceptable level Risk control interventions are implemented and operational Novel risks are identified and assessed Intrinsic resilience adequate Culture of safety established Pro-active risk monitoring established
- 6. © NHS Improving Quality 2014 The Tools / Approaches Approach Step Use Process Mapping System Definition •Document actual process •Create shared understanding •Basis for analysis Failure Mode and Effects Analysis Risk Analysis •Proactively identify risks •Prioritise risks and efforts Redundancy Risk Control •Prevent failures •Failure detection •Mitigate consequences of failures Primo –software program Risk Monitoring •Proactively identify processes that may lead to latent conditions •Prioritise efforts
- 7. © NHS Improving Quality 2014 Failure Modes and Effects Analysis (FMEA) & Root Cause Analysis • RCA is a retrospective method (process) to understand what went wrong and why. It is applied after an adverse event has happened. • FMEA is a proactive method to understand how things could go wrong and what could be the consequences of failure. It is applied before things go wrong to prevent them from going wrong.
- 8. © NHS Improving Quality 2014 FMEA is a ……………. • systematic method of identifying and preventing product and process problems before they occur. • Way of focussing on the prevention of – Defects – Enhancing safety – Increasing customer satisfaction Ideally this is done when designing the process BUT FMEA on existing processes is equally valid
- 9. © NHS Improving Quality 2014 FMEA • Systematically identify ways in which the system can cause harm (hazard identification) • Assessment of those situations for the risk they pose (risk analysis) • Particularly useful for detecting conditions where a single failure can result in a dangerous situation • Prioritise risks to focus on those situations that pose the highest risk
- 10. © NHS Improving Quality 2014 FMEA Process 1. Select Step 2. Apply Failure Mode 3. Identify Causes 4. Determine Consequences 5. Assess Risk 7. Assess Acceptability 6. Determine Mitigation Next Step Next Failure Mode If risk is not acceptable, determine further mitigation
- 11. © NHS Improving Quality 2014 FMEA Template Step Failure Mode Causes Consequences Risk MitigationFreq * Sev*Det = Risk
- 12. © NHS Improving Quality 2014 Risk Matrix
- 13. © NHS Improving Quality 2014 Variation: Detection Step Failure Mode Causes Consequences Risk Mitigation Freq * Sev * Det = Risk Risk Component Low High Frequency 1 5 Severity 1 5 Detection 5 1
- 14. © NHS Improving Quality 2014 EXAMPLE Step Failure Mode Causes Consequences Risk Freq x sevxdet = risk Mitigation Establish Medication History Failure to identify the medicines that the patient is taking at home Patient confused about medication Relatives not available Medical notes not available Patient did not bring medicines to the hospital Wrong medicine or dose prescribed Omission of required medication 4x3x1=12 Raise awareness in community for patients to bring their current medicines into the hospital
- 15. © NHS Improving Quality 2014 EXERCISE • Using your process map complete the FMEA for your process.
- 16. © NHS Improving Quality 2014 Failure Detection (Redundancy) & Mitigation • Using the strategies discussed earlier, we can reduce human error, but we will never be able to eliminate it. • We need ways of coping with (mitigating) failures in our systems and processes
- 17. © NHS Improving Quality 2014 Cartoon Example: Pitfall
- 18. © NHS Improving Quality 2014 Why was there a hole on the road in the first place?!
- 19. © NHS Improving Quality 2014 Redundancy & Diversity: Defences in depth Violations & latent failures: Safety Management & Safety Culture
- 20. © NHS Improving Quality 2014 Redundancy • Failure detection and mitigation are achieved by some form of redundancy • Having a system that is more complex than that needed simply to perform the task
- 21. © NHS Improving Quality 2014 REDUNDANCY & MITIGATION Failure Occurs Adverse Event Failure Occurs Adverse Event Mechanism To prevent Failure Mechanism to Detect and Recover from Failure
- 22. © NHS Improving Quality 2014 Common Failure Detection Mechanisms Make failures visible: Self-soiling mattress Checking: Double checking Information redundancy: Diverse patient identifiers Consistency check: Does the medication dose make sense? Loopback testing: Reading back on the phone Watchdog timer: If results have not come back within an hour, query the lab
- 23. © NHS Improving Quality 2014 Common Barrier Systems Procedural / Cultural: Procedures e.g peer pressure for hand hygiene Symbolic: Signs e.g. hand hygiene when entering wards Functional: Must fulfill a pre-condition before progressing e.g. Keyboard will stop working if not wiped regularly Physical: Isolation of patients
- 24. © NHS Improving Quality 2014 Some Problems With Redundancy • Redundant steps have to be independent, but often are not Over-reliance: • On people: double-checking • On machines: mammography reading – Cultural aspects: hierarchy – Unclear allocation of responsibility • Increased system complexity – New failure modes – Unanticipated interactions
- 25. © NHS Improving Quality 2014 Process Map & Standardisation Identify and Prioritise Risk Barriers and Mitigation Test and Refine Deliberate reliable design
- 26. © NHS Improving Quality 2014 EXERCISE • Design a redundancy for your process.
- 27. © NHS Improving Quality 2014
- 28. © NHS Improving Quality 2014