Product Safety Risk Assessment Methodology (PRISM)
The guide, toolkit and further information for GB authorities with responsibility for consumer product safety.
Applies to England, Scotland and Wales
The Product Safety Risk Assessment Methodology (PRISM) is for use by market surveillance authorities and enforcing authorities in Great Britain with responsibility for consumer product safety. It is aligned with the EU Safety Gate approach (RAPEX) and reflects the same risk level matrix. PRISM was launched by OPSS in 2022 after extensive engagement with local authorities and national regulators and has resulted in more robust and informed risk assessments.
PRISM should be used by GB authorities for product safety risk assessment.
While PRISM is intended for the risk assessment of general non-food consumer products, authorities with responsibility for other types of products may find it useful, in whole or in part. OPSS continues to monitor its effectiveness, both generally and in relation to innovative products and emerging technologies. To this end your feedback on the use of PRISM is very welcome. Please contact [email protected].
PRISM V2 guide and toolkit
The PRISM guide sets out the fundamentals of product safety risk assessment in Part 1 and covers a range of risk-related topics in Part 2.
There have been some important updates made to PRISM, based on user feedback and real-life application. The amendments are not material in terms of the overall methodology and are set out below:
- Definition of 鈥榥on-compliant鈥� added (Part 1, Section 1.3).
- Presumption of serious risk application and effect (Part 1, section 1.5, stage 1) amended to make clear it is not an exemption to undertake a risk assessment. Instead, a relevant risk assessment exists, and the assessor must apply its outcome to the specific product and circumstances concerned. As this presumption is supported by an evolving list of hazards and/or products, this amendment is covered in supporting guidance (see below).
- List of product hazards amended to include 鈥榝unctional鈥� (Part 1, section 2.2, table 1). This new hazard concerns harm linked to the function of the product, such as drowning for products intended to be used on or near water.
- 鈥楶roduct prevalence鈥� table amended to make the categories exclusive (Part 1, section 2.2, table 4).鈥�Note: categories were always intended as exclusive which has always been reflected in the MS Excel toolkit.
- Inclusion of product prevalence as factor to be considered and reflected in risk evaluation (Part 1, section 3.1).
- Clarification within factors related to tolerability (Part 1, section 3.2) as in many cases there will be no public concern, and the basis for this assumption.
The PRISM toolkit is now built into the Product Safety Database (PSD). This means GB regulators no longer need to record the outcomes of their risk assessment in the MS Excel toolkit but can record their risk assessment as part of the notification process. In addition, multiple hazards can now be combined where the toolkit will calculate new probability levels for the product, which wasn鈥檛 possible in the MS Excel tool.
An Excel version of the PRISM toolkit will continue to be available as it still provides the triage tool function 鈥� a link to which is included in the PSD 鈥� and is used by non-regulators as a good way to capture post-market risk assessment outcomes.
Further information that may be relevant and useful in some circumstances is also provided below.
OPSS PRISM resources
Products and hazards presumed serious risk
Risk assessment examples
Below are some fictitious examples of product safety risk assessments undertaken using the PRISM methodology, with three new worked examples that concern a less than serious risk outcome, including a detailed worked example dealing with multiple hazards. The examples have additional explanation to highlight the thinking behind the approach taken and some of the conclusions drawn. Please note that the detail of the risk assessments including the probabilities highlighted should not be transferred to other assessments. They are provided primarily to illustrate the application of PRISM and not as an OPSS position on the issues featured.
- New 鈥� Non-compliant cords and drawstrings in children鈥檚 clothing (less than serious risk)
- New 鈥� Non-compliant juice blender (less than serious risk and covers multiple hazards)
- New 鈥� Non-compliant toy with detachable part (less than serious risk)
- Non-compliant car seat
- Non-compliant room / space heater
- Non-compliant remote control for lighting chain
Open-source data sets to support risk assessment
Scientific Advisory Group for Emergencies
鈥� RoSPA website
鈥� NHS England website
Fire statistics data tables 鈥� Home Office
Statistics 鈥� Department for Transport
鈥� Office for National Statistics
鈥� United States Consumer Product Safety Commission website
鈥� United States Consumer Product Safety Commission website
鈥� European Chemicals Agency website
Examples of academic literature resources:
- website
- website
- website
(Please note that some papers may require payment to access.)
鈥� Prosafe website
Updates to this page
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PRISM guide amended, with the main changes summarised in the page text, and three new risk assessment examples provided.
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Minor amendments made to the PRISM toolkit in response to stakeholder feedback.
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Risk assessment example added for non-compliant remote control for lighting chain.
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First published.