Risk assessment: the key to regulating product safety?
Product safety has gained prominence over the past decades and has been supported by the development of national and international safety standards.
Requirements for the reliability, performance and safety of a specific product type were originally contained in one standard specifying construction, thermal and electrical characteristics and product performance.
The trend has been to separate construction and safety from performance requirements.
This led to the publication of many “safety specifications”, some of which were made compulsory by the regulatory authorities. To warrant the implementation of compulsory specifications, their development is normally preceded by risk assessments for which acceptable reliable risk assessment methodology is applied.
It has come to my attention that the methodology recently introduced by the NRCS on the specification for general service electric lamps (GSLs), being developed at present, gives totally conflicting results.
NRCS methodology for risk assessment
The risk assessment methodology was developed by NRCS and introduced in 2012 as part of the development process for compulsory specifications. The NRCS, which has adopted a “risk-based approach”, would use the outcomes of risk assessments to establish the need for and feasibility of regulation and the implementation of compulsory specifications.
The GSLs project
This project was launched to regulate the performance and efficiency requirements for GSLs and, in particular, to ensure optimum energy consumption on LED lamps, which could lead to significant savings to the South African economy.
Statistics show that general service lamps are generally manufactured to voluntary international standards. Some 180-million GSLs are used annually in this country without significant reports of safety hazards.
In response to the NRCS risk assessment for GSLs, which indicated that GSLs should be regulated by implementing two compulsory safety specifications (for safety and performance respectively), some technical committee members raised concerns over the NRCS’ risk assessment methodology.
One of the technical committee members also applied the risk assessment to a trivial example of the ordinary table knife, which has the potential to cause accidental death. The scores obtained for table knives and electric lamps both indicate a “moderate” risk and that NRCS should also regulate table knives and forks involving pre-approval and moderate surveillance.
When applying the EU risk assessment methodology to GSL, the overall probability of death results in a figure of 0,000 0003. If multiplied by the catastrophic score (300, indicating death from electric shock) we arrive at a risk rating of 0,000 099 (insignificant).
Something is amiss
Motivations against the risk assessment methodology were formally presented to the NRCS RR&D management, and it was requested that this matter be referred to an NRCS specialist technical committee for review. The request was summarily rejected with the management stating that “NRCS is not allowed to deviate from its procedures”.
It is clear that the NRCS does not intend to consider this request.
Remarks
A stakeholder who subsequently withdrew from the technical committee summarised the situation as follows:
“This is not effective consultation, but a procedure for obtaining apparent stakeholder support falsely for a decision already made.
“This approach will certainly have severe negative impacts on a rapidly developing lighting and electrotechnical industry through the introduction of unnecessary and possibly cumbersome regulations based on questionable risk assessment methodology.
“It is essential that the methodology be reviewed by a team of experts in the various technologies to reflect international best practice. Although the NRCS Act makes provision for specialist technical committees, no such committees exist to deal with these matters (the present NRCS risk assessment methodology is an in-house development).
“Product ranges can be varied, with operating voltages ranging up to 1000 V AC or DC. A generic risk assessment cannot be applied for separated extra-low voltage (SELV), low voltage and medium voltage products.
“In the event of non-compliance, the risk assessment must be conducted on individual cases to ensure that appropriate action is taken to minimise the hazard. This may take on various forms, including warning labels, repair, recall and disposal.”
Contact Connie Jonker, SAFEhouse, Tel 011 396-8140, connie.jonker@safehousesa.co.za
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