risk analysis and control nhsiq 2014

© NHS Improving Quality 2014

Risk Analysis and Control

Patient Safety Team


“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)


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.


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

Incidentreporting

Risk monitoring

0

10

20

30

40

50

60

Jan Feb Mar Apr May June

Dose

Frequency

Drug


ResilienceG: 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 resilienceadequate

Culture of safetyestablished

Pro-active riskmonitoring established


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


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.


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


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


FMEA Process1. Select Step

2. Apply Failure Mode

3. Identify Causes

4. Determine Consequences

5. Assess Risk

7. Assess Acceptability

6. Determine Mitigation

Next Step

Next FailureMode

If risk is not acceptable, determine further mitigation


FMEA Template

Step Failure Mode Causes Consequences

RiskMitigationFreq * Sev*Det = Risk


Risk Matrix


Variation: Detection

Step Failure Mode Causes Consequences

RiskMitigation

Freq * Sev * Det = Risk

Risk Component Low High

Frequency 1 5

Severity 1 5

Detection 5 1


EXAMPLEStep Failure

ModeCauses 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


EXERCISE

• Using your process map complete the FMEA for your process.


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


Cartoon Example: Pitfall


Why was there a hole on the road in the first place?!


Redundancy & Diversity: Defences in depth

Violations & latent failures: Safety Management & Safety Culture


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


REDUNDANCY & MITIGATION

Failure Occurs Adverse Event

Failure Occurs Adverse Event

Mechanism To prevent

Failure

Mechanism toDetect and

Recover fromFailure


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


Common Barrier SystemsProcedural / 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 progressinge.g. Keyboard will stop working if not wiped regularly

Physical:

Isolation of patients


Some Problems With Redundancy

• Redundant steps have to be independent, but often are notOver-reliance:

• On people: double-checking• On machines: mammography reading

– Cultural aspects: hierarchy– Unclear allocation of responsibility

• Increased system complexity– New failure modes– Unanticipated interactions


Process Map & Standardisation

Identify and Prioritise Risk

Barriers and Mitigation

Test and Refine

Deliberate reliable design


EXERCISE

• Design a redundancy for your process.


HARM

risk analysis and control nhsiq 2014

Healthcare