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AcmeLimited Risk Analysis

AcmeLi
Risk mangement plan

Product Name: Date: Criteria for risk ac

Product Number:

Life cycle phases for which this plan is applicable (tick all applicable)

Design and development

Manufacturing process

Storage and transportation

End user

Verification
For completeness of plan the following must be verified:

Title Responsibility Due date Verification by Date


Risk analysis
Comments
Risk evaluation

Risk control

Risk management report

Responsibilities
Who will be responsible for the following?

Title Responsibility
Risk analsis team

Risk analysis

Risk evaluation

Risk control

Risk management report

Setting of acceptance criteria

Authority to change plan


Signed
Resource management

Position
AcmeLimited Risk Analysis
Risk mangement plan

eria for risk acceptability

ments

Date:
AcmeLimited Risk Analysis
Intended use/purpose worksheet

Product Name:

Product Number:

Reviewed by: Date:

Technical description of product and construction.

Step 1 Intended use / intended purpose of the device.


AcmeLimited Risk Analysis
Hazard identification worksheet
Step 2 List all foreseeable hazards in both normal and fault conditions.
AcmeLimited Risk management
Risk control charts
Severity
Severity Criteria Rating
A very minor failure which has no effect on product/system performance, customer would not
1
Minor notice failure.
A minor failure causing only slight customer annoyance. Customer would not notice any 2
Low deterioration in product/system performance. 3
A failure which would cause some customer dissatisfaction or annoyance (eg low flow) and 4
would cause noticeable deterioration in product/system performance but not affect the safety 5
Moderate of the product/system. 6
A failure which would involve a high degree of customer dissatisfaction but does not affect 7
High product/system safety. 8
Very high A failure which would affect safety (near incident). 9
Catastrophic A failure that could cause death or serious injury to user or patient (incident). 10

Occurance

Occurrence Criteria CPK Rate Rating


Remote It would be unreasonable to expect the failure to occur ≥1.67 ≤ 1 to 1,500,000 1
≥1.50 1:150,000 2
Failure unlikely to occur
Low ≥1.33 1:15,000 3
≥1.17 1:2000 4
Failure could occur, but not in major quantities ≥1.00 1:400 5
Moderate ≥0.83 1:80 6
≥0.67 1:20 7
Failure will occur
High ≥0..51 1:08 8
≥0.33 9
Failure certain ≥1:2
Very high <0.33 10

Detection

Detection Criteria Rating


Almost certain Current controls almost certain to detect failure mode. 0 to 5% 1
Very high likelihood that current controls will detect failure mode. The defect is obvious or all
product is 100% automatically inspected with regular calibration and preventative 6 to 15% 2
Very high maintenance of the inspection equipment.
Very high likelihood that current controls will detect failure mode. All product is 100%
16 to 25% 3
High automatically inspected.
High likelihood that current controls will detect failure mode. SPC is used an immediate
26 to 35% 4
Moderately high corrective actions to out-of control conditions.
Moderate likelihood that current controls will detect failure mode. Some SPC is used in
36 to 45% 5
Moderate process and product is final inspected off line.
Low likelihood that current controls will detect failure mode. Product is 100% manually
46 to 50% 6
Low inspected in process using gauges or other mistake-proofing gauges.
Very low likelihood that current controls will detect failure mode. Product is 100%
51 to 65% 7
Very Low manually/visually inspected in process.
Remote likelihood that current controls will detect failure mode. Product is accepted based on
66 to 75% 8
Remote no defects in sample.
Very remote likelihood that current controls will detect failure mode. Product is sampled,
76 to 85% 9
Very Remote inspected and released on an AQL sampling plan.
Absolute No known control available to detect the failure mode. 86 to 100% 10
uncertainty

The above tables have been reviewed and accepted as the standard to be used for this Risk analysis of the
following product:

Signed
Position
AcmeLimited Risk Analysis

Product Name: 0 Initial issue Date: Revision Date:

Product Number: 0 Sheet 1 of Revision Issue

Team Members: R.Saunders, S.Hodgkins, R.McMullin

Occurrence
Action results

Detection
Recommended

Severity
Hazard Potential Failure Potential Effects of Potential causes of Risk index Resp. & target
Risk control method (SxOxD) actions for risk
ID mode (Hazard) Failure (Risk) failure completion date Action taken &

Index
Completion

Sev
reduction

occ
det
verification reference Date

-
AcmeLimited Risk Analysis

Product Name: 0 Initial issue Date: Revision Date:

Product Number: 0 Sheet 1 of Revision Issue

Team Members: R.Saunders, S.Hodgkins, R.McMullin

Occurrence
Action results

Detection
Recommended

Severity
Hazard Potential Failure Potential Effects of Potential causes of Risk index Resp. & target
Risk control method (SxOxD) actions for risk
ID mode (Hazard) Failure (Risk) failure completion date Action taken &

Index
Completion

Sev
reduction

occ
det
verification reference Date

-
AcmeLimited Risk Analysis
Risk reduction - Option analysis worksheet

Product Name:

Product Number:

Reviewed by: Date:

Step 7 All residual risks shall be evaluated against the criteria defined in the risk management plan.
If the risk does not meet the criteria then a new risk assement and control measure plan (FMEA)
shall be implemented, if acceptable all relevent information necessary to explain the residual risks
shall be placed in the appropriate documentation supplied by the manufacturer.

Hazard ID Risk identified Acceptability justification


Risk Analysis
ion analysis worksheet

k management plan.
ure plan (FMEA)
n the residual risks
AcmeLimited Risk Analysis
Risk Reduction - Risk/benefit analysis

Product Name:

Product Number:

Reviewed by: Date:

Step 8 Does the medical benefit out-weigh the risk (s) involved?
To be completed if the risk is judged unacceptable and further risk control is impractical.
List all unavoidable risks list all medical benefits
Attach all evidence to report

The medical benefits have been/not been proved to outweigh the risks involved in using this device
We therefore judge this device to have an un/acceptable risk level an will inform the user of any residual risk
involved in the use of this device.

Signed: Date:
Position:
al risk
AcmeLimited Risk Analysis
Risk reduction - Generated hazards worksheet

Product Name:

Product Number:

Reviewed by: Date:

Step 9 Other generated hazards


List all hazards generated from risk control measures (if any). These are to be transferred to risk evaluation
worksheet and re-evaluated.
AcmeLimited Risk Analysis
Completeness of assessment worksheet

Product Name:

Product Number:

Reviewed by: Date:

Step 10 Completeness review of risk evaluation.

Review all hazards listed in step 2 for completeness of risk evaluation, list any risk (s) that have been omitted
and enter onto new risk evaluation worksheet at step 3.

Sign: Date:
Position:
been omitted
AcmeLimited Risk Analysis
Overall residual risk evaluation worksheet

Product Name:

Product Number:

Reviewed by: Date:

Step 11 Does the overall medical benefit out-weigh the residual risks involved?
List all unavoidable residual risks list all medical benefits
Attach all evidence to report

The medical benefits have been/not been proved to outweigh the risks involved in using this device
We therefore judge this device to have an un/acceptable risk level an will inform the user of any residual risk
involved in the use of this device.

Signed: Date:
Position:
al risk
AcmeLimited Risk Analysis
Risk Management report

Product Name:

Product Number:

Reviewed by: Date:

Risk Management report.

Have the following reviews been completed and judged acceptable?


Check list: Sign Date

Step 1 Intended use/purpose and identification of characteristics related


to the safety of the device

Step 2 Identification of known or foreseeable hazards.

Step 3 Estimation of the risk (s) for each hazard.

Step 4 Risk evaluation.

Step 5 Risk reduction - option analysis

Step 6 Risk reduction - Implementation of risk control measures

Step 7 Risk reduction - residual risk evaluation

Step 8 Risk reduction - risk/benefit analysis

Step 9 Risk reduction - Other generated hazards

Step 10 Completeness of risk evaluation.

Step 11 Overall residual risk evaluation.

We have studied the hazards and risks associated with the above product (s) and have judged
that the risk (s) arising from hazard (s) generated by the manufacture and use of this product are
of an acceptable level at this time. We will review any new risk (s) arising and update the risk
management file accordingly.

Signed: Date:

Position: