Risk Management SOP for ISO14971

LOGO HERE Doc. No: : SOP-013

Rev. No: : 0

Effective Date : 5 Mar 2014

Risk Management Page : 1 of 17

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1.0 PURPOSE

1.1 The purpose of this process is to specify the working methodology by which various product risks can be identified, estimated, evaluated and controlled during the various design and production phases of the project.

2.0 SCOPE

2.1 This procedure is applicable to the design process undertaken for a new or modified product.

2.2 This procedure is applicable to the production process undertaken for a new or modified product, where applicable.

3.0 REFERENCES

3.1 ISO 14971 Medical Devices – Application of risk management to medical devices

4.0 APPLICABLE DOCUMENTS

4.1 Customer Requirements Checklist4.2 Product Risk Management 4.3 Process Risk Management

5.0 RESPONSIBILITIES

5.1 The Project Leader shall be responsible, with the project team, in defining Risk Acceptability due to product risk management, taking into account relevant international standards and national or regional regulations.

5.2 The Project Leader shall be responsible for an up-to-date record of Product Risk Management listing product risks identified, estimated, evaluated and controlled from reviews of the product risk management activities at each Design Review or when required.

5.3 The Project Leader shall be responsible, with the Process Owner/s and/or Foundry Manager, in defining the Risk Acceptability due to process risk management, taking into account relevant international standards and national or regional regulations.

6.0 RISK MANAGEMENT PROCEDURES

6.1 Product Risk Management



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6.1.1 Risk Management Planning

The various steps involved in the product risk management planning include: (a) Availability of Information

The participating team members shall gather appropriate technical information, such as those captured in Customer Requirements Form and post-market information, such as complaints/incidents of the product from previous iterations or of similar products, etc to identify product risks.

(b) Identifying the Risk Management Process The participating team members define the scope of the plan as to which devices and their intended use.

(c) Assignment of ResponsibilitiesThe participating team members shall assume their respective responsibilities based on expertise, representation and level of involvement in the respective phase of the project. Service providers should be appropriately involved if the need arises.

(d) Defining Risk Acceptability CriteriaThe participating team members shall review the existing risk acceptability criteria which are based on Likelihood of Occurrence, Likelihood of Detection and Severity factors as listed in 6.1.3 Risk Identification and Analysis.

6.1.2 Conducting of Risk Management Process

(a) The risk management process consists of 5 steps, namely:

(i) Risk Identification and Analysis(ii) Risk Evaluation(iii) Risk Control(iv) Residual Risk Evaluation(v) Post Production Information

the outcome of which is recorded in Product Risk Management

6.1.3 Risk Identification and Analysis

(a) The team starts with the identification of risks and/or reviews the post-production information, safety characteristics and control plan, to list known and/or foreseeable risks in both normal and fault conditions using the Product Risk Management whenever there is a new or change in the product design of the device.

(b) For each hazard identified, deliberate if the effects of the hazard will be catastrophic or chaotic (i.e. C factor). If it is, it will be recorded accordingly and no further action is required in this step.



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(c) If it is not, proceed to rate the hazard’s

(i) Likelihood of Occurrence (i.e. O factor)(ii) Likelihood of Detection (i.e. D factor) (iii) Severity (i.e. S factor)

according to 6.1.3(d) Table 1 - Likelihood of Occurrence (O) Factor, 6.1.3(e) Table 2 - Likelihood of Detection (D) Factor and 6.1.3(f) Table 3 - Severity (S) Factor.

(d) Table 1 - Likelihood of Occurrence (O) Factor.Rating

O = Likelihood of Occurrence Criteria

X Cannot Be Estimated -5 Always 1 in 104 Frequent 1 in 1003 Occasional 1 in 1,0002 Probable 1 in 10,0001 Remote 1 in 100,000

(e) Table 2 – Likelihood of Detection (D) Factor.Rating

D = Likelihood of Detection Criteria


(f) Table 3 - Severity (S) Factor.Rating

S = Severity Criteria

5 CriticalCan result in user being hospitalised.Outcome does not mitigate hazard.Death or Serious Injury is possible.

4 SeriousWill require the user to consult a medical doctor.Outcome might mitigate hazard or 2 times better.

Death or Serious Injury is possible.



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3 MildWill need the user to monitor for ill effects.

Outcome barely mitigates hazard or 3 times better.Non-serious Injury is possible.

2 NormalRequires user to seek First Aid treatment.

Outcome partially mitigates hazard or 4 times better.Non-serious Injury is possible.

1 Negligible

Rinsing and Washing will suffice.Outcome completely mitigates hazard or 5 or more

times better.No Injury or damage to Health is possible.

(g) For hazards for which the probability of the occurrence of harm cannot be estimated, a listing of the possible consequences shall be made.

6.1.4 Risk Evaluation

(a) The Risk Priority Number is computed by the product of the O, D and S factors according to the FMEA Approach Strategy of ODS as shown in 6.1.4(c) Table 4 – Risk Evaluation Matrix.

(b) The value of the Risk Priority Number will result in the identified hazard falling into one of 4 possible regions:

(i) BlankThe value of the P, O and/or D cannot be estimated. The team or designate will evaluate the list of possible consequences and decide accordingly.

(ii) Intolerable, 50 ≤ RPN ≤ 125The C factor is “Yes” or the range of values for the Priority Factor falls into this region. Death or serious injury is possible. Control measures have to be implemented to further reduce it to the regions of ALARP or preferably to Broadly Acceptable. If it is not possible, a risk/benefit analysis has to be conducted. Refer also to 6.2.3 Risk Control and 6.2.4 Residual Risk Evaluation steps.

(iii) ALARP (As Low As Reasonably Practicable), 10 ≤ RPN ≤ 48Non-serious injury is possible. Control measures preferably have to be implemented to further reduce it to that of the Broadly Acceptable. If it is not possible, a risk/benefit analysis has to be conducted. Refer also to 6.2.3 Risk Control and 6.2.4 Residual Risk Evaluation steps.

(iv) Broadly Acceptable (BA), 1 ≤ RPN ≤ 9No Injury or damage to Health is possible. No control measures need to be implemented and the product can be used without any disruption.



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(c) Table 5 – Risk Evaluation matrixAlways(O =5 )Remote(D=5)

ALARP(RPN=25)

Intolerable(RPN=50)

Intolerable(RPN=75)

Intolerable(RPN=100)

Intolerable(RPN=125)

Frequent(O =4)

Probable(D=4)

ALARP(RPN=16)

ALARP(RPN=32)

ALARP(RPN=48)

Intolerable(RPN=64)

Intolerable(RPN=80)

Occasional(O =3)

Occasional(D=3)

BA(RPN=9)

ALARP(RPN=18)

ALARP(RPN=27)

ALARP(RPN=36)

ALARP(RPN=45)

Probable(O =2)

Frequent(D=2)

BA(RPN=4)

BA(RPN=8)

ALARP(RPN=12)

ALARP(RPN=16)

ALARP(RPN=20)

Remote(O =1)Always(D=1)

BA(RPN=1)

BA(RPN=2)

BA(RPN=3)

BA(RPN=4)

BA (RPN=5)

Negligible(S=1)

Normal(S=2)

Mild(S=3)

Serious(S=4)

Critical(S=5)

where: (i) Risk Priority Number, RPN = Likelihood of Occurrence (O) x Likelihood of Detection (D) x Severity (S)(ii) If the hazard is catastrophic, the risk evaluation is Intolerable regardless of the rating of the RPN.

6.1.5 Risk Control

(a) Hazards falling into the Intolerable region will require options to be generated for control and/or mitigation of the identified hazard. After having implemented the control measures, the Risk Priority Number shall be reviewed once again.

(b) The effectiveness of the control measures is reflected by the magnitude of the reduction in the Risk Priority Number.

6.1.6 Residual Risk Evaluation

(a) If, after risk control has been implemented, the outcome is still Intolerable, more control measures need to be implemented.



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(b) If this is not possible, a Risk/Benefit Analysis needs to be conducted. The decision as to whether risks are outweighed by benefits is essentially a matter of judgment by experienced and knowledgeable individuals. Those involved in the risk/benefit judgments have a responsibility to understand and take into account the technical, clinical, regulatory, economic, sociological and political context of their risk management decisions.

In order of preference, the following people should be employed to conduct the risk review and risk/benefit analysis:

(i) Expert or relevant to area of review (e.g. clinicians, researchers, subject experts)(ii) Engineers/Designers external to the project(iii) Cross functional project team members (e.g. Industrial Design, Biomedical, EE, ME)(iv) Literature review not dating back more than 10 years

(c) An important consideration in the acceptability of a residual risk is whether an anticipated clinical benefit can be achieved through the use of alternative design solutions that avoid exposure to the risk or reduce the overall risk.

(d) Benefit can be estimated from the below factors:

(i) the performance expected during clinical use(ii) the clinical outcome expected from that performance(iii) the factors relevant to the risks and benefits of other treatment options

(e) Provisional use of the product can be granted pending outcome of Risk/Benefit analysis for cases where the S is rated Serious or Critical.

(f) If other hazards are introduced by any risk control measures, the associated risks shall be assessed as per 6.1.3 Risk Identification and Analysis.

6.1.7 Signing-Off of Risk Management Report

(a) The team or designate shall assure that the risk(s) from all identified hazards have been evaluated and conclude on the acceptability or unacceptability of the overall residual risk evaluation as defined in the 6.1.1 Risk Management Planning.

(b) A signing-off of the Product Risk Management by all members of the team and the Management Representative as the final approving signature will indicate this. The individual functions and roles are to be appropriately defined in Product Risk Management.

6.1.8 Post Production Information

(a) The team shall review the information gained about the devices or similar devices in the postproduction. Information relevant to safety are evaluated, especially the following:

(i) if previously unrecognised hazards are present



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(ii) if the estimated risk risks arising from a hazard is no longer acceptable(iii) if the original assessment is otherwise invalidated

(b) If any of the above conditions (i), (ii) or (iii) is satisfied, the result will be input to the risk management process.

(c) If there is a potential that the residue risk or its acceptability has changed, the impact on previously implemented risk control measures shall be evaluated and the results recorded.

6.2 Process Risk Management

The process risk management is to be included for the in-house production provision. The various steps involved in the process risk management planning are:

6.2.1 Risk Management Planning

(a) Availability of InformationThe participating team members shall gather appropriate technical information and post-market information, such as complaints/incidents of the product from previous iterations or of similar products, etc to identify product risks due to process risks.

(b) Identifying the Risk Management Process The participating team members define the scope of the plan as to which devices and their intended use.

(c) Assignment of ResponsibilitiesThe participating team members shall assume their respective responsibilities based on expertise, representation and level of involvement in the respective phase of the project. Service providers should be appropriately involved if the need arises.

(d) Defining Risk Acceptability CriteriaThe participating team members shall review the existing risk acceptability criteria which are based on Likelihood of Occurrence, Likelihood of Detection and Severity factors as listed in 6.1.3 Risk Identification and Analysis.

6.2.2 Conducting of Risk Management Process

(a) The risk management process consists of 5 steps, namely:

(i) Risk Identification and Analysis(ii) Risk Evaluation(iii) Risk Control(iv) Residual Risk Evaluation(v) Post Production Information

the outcome of which is recorded in Process Risk Management



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6.2.3 Risk Identification and Analysis

(a) The team starts with the identification of process risks and/or reviews the post-production information, to list known and/or foreseeable risks in both normal and fault conditions using the Process Risk Management (-SOP-013-2) whenever there is a new or change in the production process of the device.

(b) For each hazard identified, deliberate the effects of the hazard on the process and on the end user or customer.

(c) If it is not, proceed to rate the hazard’s

(i) Likelihood of Occurrence (i.e. O factor)(ii) Likelihood of Detection (i.e. D factor) (iii) Severity (i.e. S factor)

according to Table 5 - Likelihood of Occurrence (O) Factor, Table 6 – Likelihood of Detection (D) Factor and Table 7 - Severity (S) Factor.

Table 5 - Likelihood of Occurance (O) FactorRating

O = Likelihood of Occurance Criteria


Table 6 - Likelihood of Detection (D) FactorRating

D =Likelihood of Detection

Criteria

X Cannot Be Estimated

-

5 Remote Failure mode cannot be detected or is not checked.4 Probable Failure mode cannot be easily detected.3 Occasional Control is achieved with 100% manual inspection by

visual means.2 Frequent Control is achieved with 100% manual inspection using

variable or attribute gauging.1 Always Failure mode is obvious or failure mode is not possible

because of error-proofing by process/product design.



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Table 7 - Severity (S) FactorRating

S =Severity Criteria

(Customer) Criteria (Process)

5 Critical Failure affects customer safety or involves noncompliance to government regulations

100% of the product may have to be scrapped.

4 Serious High degree of customer dissatisfaction due to failure of product function.

100% of the product may have to be reworked.

3 Mild Failure causes some deterioration of product performance, but will not result in failure of product function.

A portion of the product may have to be reworked/ scrapped.

2 Normal Failure causes slight deterioration of product performance.

May result in slight inconvenience with a subsequent process or assembly operation.

1 Negligible Unreasonable to expect that failure will have any noticeable effect on product performance.

Unreasonable to expect that the failure will have any noticeable effect on subsequent process or assembly operation.

(d) For hazards for which the probability of the occurrence of harm cannot be estimated, a listing of the possible consequences shall be made.

6.2.4 Risk Evaluation

(d) The Risk Priority Number is computed by the product of the O, D and S factors according to the FMEA Approach Strategy of ODS as shown in 6.1.4(c) Table 4 – Risk Evaluation Matrix.

(e) The value of the Risk Priority Number will result in the identified hazard falling into one of 4 possible regions:

(i) Blank The value of the P, O and/or D cannot be estimated. The team or designate will evaluate the list of possible consequences and decide accordingly.



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(ii) Intolerable, 50 ≤ RPN ≤ 125Death or serious injury is possible. Control measures have to be implemented to further reduce it to the regions of ALARP or preferably to Broadly Acceptable. If it is not possible, a risk/benefit analysis has to be conducted. Refer also to 6.2.3 Risk Control and 6.2.4 Residual Risk Evaluation steps.

(iii) ALARP (As Low As Reasonably Practicable), 10 ≤ RPN ≤ 48Non-serious injury is possible. Control measures preferably have to be implemented to further reduce it to that of the Broadly Acceptable. If it is not possible, a risk/benefit analysis has to be conducted. Refer also to 6.2.3 Risk Control and 6.2.4 Residual Risk Evaluation steps.

(iv) Broadly Acceptable (BA), 1 ≤ RPN ≤ 9No Injury or damage to Health is possible. No control measures need to be implemented and the product can be used without any disruption.

6.2.5 Risk Control

(a) The current process controls and any additional recommended process controls are to be implemented are listed. Based on the control measures, the Risk Priority Number shall be reviewed once again.

(b) The effectiveness of the control measures is reflected by the magnitude of the reduction in the Risk Priority Number.

6.2.6 Residual Risk Evaluation

(a) If, after risk control has been implemented, the outcome is still Intolerable, more control measures need to be implemented.

(b) If other hazards are introduced by any risk control measures, the associated risks shall be assessed as per 6.2.1 Risk Identification and Analysis.

6.2.7 Signing-Off of Risk Management Report

(a) The team or designate shall assure that the risk(s) from all identified hazards have been evaluated and conclude on the acceptability or unacceptability of the overall residual risk evaluation as defined in the 6.2.1 Risk Management Planning.

(b) A signing-off of the Process Risk Management (-SOP-013-2) by all members of the team will indicate this. The individual functions and roles are to be appropriately defined in Process Risk Management (-SOP-013-2).

6.2.8 Post Production Information

(b) The team shall review the information gained about the devices or similar devices in the postproduction. Information relevant to safety are evaluated, especially the following:



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(v) if previously unrecognised hazards are present(vi) if the estimated risk risks arising from a hazard is no longer acceptable(vii) if the original assessment is otherwise invalidated

(d) If any of the above conditions (i), (ii) or (iii) is satisfied, the result will be input to the risk management process.

(e) If there is a potential that the residue risk or its acceptability has changed, the impact on previously implemented risk control measures shall be evaluated and the results recorded.

6.3 Generating Risk Management Report

(a) The Product Risk Management (-SOP-013-1) shall contain the records of the proceedings on the conduct of the product risk management process.

(b) The Process Risk Management (-SOP-013-2) shall contain the records of the proceedings on the conduct of the process risk management process.

6.4 Evaluation of Risk Management Process

(a) The team shall review the results of risk management activities during the Design Review meeting or when required.

7.0 RECORDS

7.1 Applicable records specified in sub-paragraph 4 of this procedure shall be retained in accordance to procedure -SOP-002: Control of Records.


Doc. No: : -SOP-013-1

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Product Risk Management – Cover Sheet Page : 13 of 17Doc No: SIMT/ (8-digit WBS) - Rev - XX

Project/Product Name:

Date: (DD/MM/YY)

Per -SOP-04, Section 6.5.1, the Instructions For Use of the product are not within the project scope, nor the responsibility of the Design Team, unless stated otherwise in the project proposal.

S/N Name of Reviewer(at least 2, one of which must be the customer)

Designation Function/Role Qualification Signature Date(DD/MM/YY)


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Product Risk Management – FMEA Page : 14 of 17Catastrophic (C ): Y - Yes; N – NoLikelihood of Occurrence (O): X - Cannot Be Estimated ; 1 - Remote ; 2 - Probable ; 3 - Occasional ; 4 - Frequent ; 5 – AlwaysLikelihood of Detection (D): X - Cannot Be Estimated ; 1 - Always ; 2 - Frequent ; 3 - Occasional ; 4 - Probable ; 5 – RemoteSeverity (S): 1 - Negligible ; 2 - Normal ; 3 - Mild ; 4 - Serious ; 5 – CriticalAcceptability: Intolerable C = Y or 50 ≤ RPN ≤ 125 ; ALARP (As Low As Realistically Practicable) 10 ≤ RPN ≤ 48 ; BA (Broadly Acceptable) 1 ≤ RPN ≤ 9

RISK ANALYSIS(RPN = O x D x S) RISK EVALUATION RISK CONTROL RESIDUAL RISK

EVALUATION POST PRODUCTION INFORMATIONRisk

#Compon

entFailure Mode

Failure Causes

Failure Effects C O D S RPN Acceptability Options Option

Implemented References O D S RPN Acceptability

Identify all applicable mechanical risks below:M-1M-2

Identify all applicable electrical risks below:

E-1E-2

Identify all applicable software risks below:S-1S-2

Identify all other applicable risks below:

O-1O-2


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Product Risk Management – Risk Benefit Analysis Page : 15 of 17

Risk # Benefits Risks Judgement

e.g. M-1


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Process Risk Management – Cover Sheet Page : 16 of 17Doc No.: SIMT/ (8-digit WBS)

Project/Product Name:

Date: (DD/MM/YY)

Per -SOP-04, Section 6.5.1, the Instructions For Use of the product are not within the project scope, nor the responsibility of the Design Team, unless stated otherwise in the project proposal.

S/N Name of Reviewer(at least 2, one of which must be the customer)

Designation Function/Role Qualification Signature Date(DD/MM/YY)


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Process Risk Management – FMEA Page : 17 of 17Catastrophic (C ): Y - Yes; N – NoLikelihood of Occurrence (O): X - Cannot Be Estimated ; 1 - Remote ; 2 - Probable ; 3 - Occasional ; 4 - Frequent ; 5 – AlwaysLikelihood of Detection (D): X - Cannot Be Estimated ; 1 - Always ; 2 - Frequent ; 3 - Occasional ; 4 - Probable ; 5 – RemoteSeverity (S): 1 - Negligible ; 2 - Normal ; 3 - Mild ; 4 - Serious ; 5 – CriticalAcceptability: Intolerable C = Y or 50 ≤ RPN ≤ 125 ; ALARP (As Low As Realistically Practicable) 10 ≤ RPN ≤ 48 ; BA (Broadly Acceptable) 1 ≤ RPN ≤ 9

RISK#: For Software risks, numbering goes S-1, S-2, S-3 etc. For Electrical risks, numbering goes E-1, E-2, E-3 etc. For Mechanical risks, numbering goes M-1, M-2, M-3 etc. For other risks, numbering goes O-1, O-2, O-3 etc.

RISK ANALYSIS(RPN = O x D x S)

O D S

RISK EVALUATION PROCESS RISK CONTROL

O D S

RESIDUAL RISK

EVALUATION POST PRODUCTION INFORMATIONRISK# Process Failure

ModeFailure Cause

s

Failure Effects

(Process)

Failure Effects

(Customer)RPN Accept? Current

ControlsAdditional Controls

Responsibility & Target

Completion Date

RPN Accept?


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Risk Management SOP for ISO14971