THE ROLE OF NATIONAL REGULATOR FOR COMPULSORY SPECIFICATIONS (NCRS) IN TERMS OF CONFORMITY ASSESSMENT. Speaker / Author: T Scriven Principal-author

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1 THE ROLE OF NATIONAL REGULATOR FOR COMPULSORY SPECIFICATIONS (NCRS) IN TERMS OF CONFORMITY ASSESSMENT Speaker / Author: T Scriven Principal-author Company National Regulator for Compulsory Specifications Private Bag X25, Brooklyn, Pretoria, 0075, South Africa scrivent@nrcs.org.za Phone: Fax: 086

2 Abstract Introduction The National Regulator for Compulsory Specifications (NRCS) was established on 1 September 2008, under the auspices of the National Regulator for Compulsory Specifications Act (NRCS Act), Act 5 of It emerged as an independent organisation from the original Regulatory Division of the South African Bureau of Standards (SABS) The NRCS is mandated to regulate the adherence to compulsory specifications and technical regulations in South Africa. This regulatory function addresses flaws in the market system whereby businesses may produce, import or sell products or services that may harm the consumer and / or the environment or may fall short of what is promised in terms of quantity (trade metrology) or safety. In all that it does, the NRCS is mindful of the need to balance the burden of over-regulation with the benefits of pragmatic, focused regulation. Given the mandate and its responsibility to the health and safety of consumers / the public, it was necessary to commission out a research project that will serve as a baseline study to determine the level of awareness and public understanding of the role / mandate of the NRCS. LEGAL FRAMEWORK The objects of the National Regulator are to, inter alia a) Administer and maintain compulsory specifications, and b) Carry out market surveillance through inspection in order to monitor compliance with compulsory specifications. In order to achieve its objects, the National Regulator may: (a) Inform the South African commerce, industry and the public about compulsory specifications; (b) Issue a letter of authority certificate which permits commodities or products to be sold or services to be supplied; (c) Obtain the cooperation of government departments, local authorities or other public bodies, and enter into agreements with them;

3 (d) enter into agreements with conformity assessment services providers to inspect, examine, test or analyze samples on behalf of the National Regulator; and, (e) Establish specialist consultative committees to provide input. Market surveillance inspection (MSI) MSI is defined as any activity of the National Regulator, other than testing, concerned with determining, either directly or indirectly, whether any or all of the requirements of a compulsory specification are met. Conformity Assessment As a mandated conformity assessment service provider the NRCS has set the following objectives to give effect to its mandate The objectives of this policy are to: provide clarity on the suitability of the source of evidence of conformity of commodities or products, that are only acceptable to the NRCS, wherever such evidence is required to be provided; and Define the acceptability of conformity assessment bodies that NRCS staff may submit samples of commodities or products to, for assessment of conformity. Conclusion It is essential that stakeholders experience the criteria used by regulators in the application of conformity assessment processes to be transparent, fair, relevant etc. It is therefor important to ensure that these rules are communicated to role players via various means. To ensure that test reports or certificates relied upon by the NRCS in the approval of commodities, are issued by recognized institutions. Such institution shall comply with the requirements defined by the national responsible regulatory body, in this case the NRCS. Test reports are not regarded as a Letter of Authority Certificates but only serve as acceptable evidence of conformity as part of the approval process.

4 1. Introduction Globally, many countries resorted to conformity assessment as a tool to ensure that the minimum requirements for products and services in the regulatory domain and across a wide spectrum are met. Factors that may influence compliance are e.g. economics, scarce skills and unnecessary costly duplication of testing not to mention weak or non-existent quality standards. South Africa is no exception and as a developing economy faces numerous challenges to remain productive and competitive. Needless to say it is essential that all stakeholders need to be adequately informed as to the rules and requirements before implementing a system for conformity assessment and ultimately the maintenance and sustainability thereof. It is of utmost importance that manufacturers, builders and importers understand and implement these rules. The National Regulator for compulsory Specifications (NRCS) has been mandated to administer compulsory specifications pertaining to a large variety of products that are aimed at ensuring the health, safety and environment of the citizens of South Africa as well as its trading partners. Principals of conformity Assessment that are applied 1.1 Governance The overall management approach through which executives direct and control the entire organization, using a combination of management information and hierarchical management control structures. Governance activities ensure that critical management information reaching the executive team is sufficiently complete, accurate and timely to enable appropriate management decision making, and provide the control mechanisms to ensure that strategies, directions and instructions from management are carried out systematically and effectively. 1.2 Risk management The set of processes through which management identifies, analyzes, and, where necessary, responds appropriately to risks that might adversely affect realization of the organization's business objectives. The response to risks typically depends on their perceived gravity, and involves controlling, avoiding, accepting or transferring them to a third party. Whereas organizations routinely manage a wide range of risks (e.g. technological risks, commercial/financial risks, information security risks etc.), external legal and regulatory compliance risks are arguably the key issue. 1.3 Compliance Means conforming with stated requirements. At an organizational level, it is achieved through management processes which identify the applicable requirements (defined for example in laws, regulations, contracts, compulsory specifications or technical regulations, strategies and policies), assess the state of compliance, assess the risks and potential costs of non-compliance against the projected expenses to achieve compliance, and hence prioritize, fund and initiate any corrective actions deemed necessary. 2. Conformity assessment process

5 It is the term given to the processes that are used to demonstrate through approval and market surveillance that a product (tangible) or a service or a management system or a relevant body meets specified requirements. The processes that need to be followed to be able to demonstrate that they meet the requirements are also contained in ISO/IEC standards and guides. The use of ISO/IEC standards in conformity assessment procedures allows for harmonization throughout the world and this, in turn, not only facilitates international trade between countries but also facilitates trade within countries by giving the purchaser of the product or service confidence that it meets the prescribed requirements. In South Africa the National Regulator for compulsory Specifications (NRCS) derives its mandate from the National Regulator for Compulsory Specifications Act, (Act 5 of 2008). The enabling act provides for the main objectives which are. (a) (b) (c) (d) Make recommendations to the Minister with regard to compulsory specifications; Administer and maintain compulsory specifications; Carry out market surveillance through inspection in order to monitor compliance with compulsory specifications; and Enforce compliance with compulsory specifications. 2.1 Developing standards The consultation process, as per regulation, is a three stage activity and includes the initial, second and final consultation, with all relevant stakeholders for recommendation thereof by the NRCS Board to the Minister. Prior to engaging in consultation process a proposal must be made to the CEO of the NRCS. Such a proposal shall be motivated by a feasibility proposal before a request for the development of a standard. Consultation meetings involve participation by technical experts representing stakeholders before a recommendation is made to the minister. During the initial technical working group the proposed intervention is discussed as well as the identification of risks with such intervention. As the recognized South African Standards development body, the SABS will be requested to prepare national standards applicable to the product to be regulated, and need to provide it within reasonable time. Where this is not possible the NRCS may proceed with the consultation process. 2.2 Sampling

6 Sampling plans need to be statistically valid and are based on batch sizes per commodity. These sampling plans are used in conjunction with the execution of surveillance inspections or in the event where products are sampled for initial approval or in the case of verification of compliance through Conformity of Production (COP). Unless sampling techniques are specifically defined in the Compulsory Specification or Technical regulation or other applicable legislation, the following sampling techniques shall apply: Each Division responsible for regulating products covered by Compulsory Specifications shall compile and use a Sampling Plan based on the minimum following criteria: i) When any Model of a product type, from a specific source, is first introduced into the RSA market place, the Division responsible for it s regulation shall ensure that a sample is taken and evaluated against the requirements of the applicable Technical Regulation. ii) Subsequent Samplings of each Model (in the above) shall be taken annually to a Special Inspections Levels S-1 of SANS : Single sampling plans for normal inspections. 2.3 Testing As per the definition of surveillance inspection it is clear that it excludes testing. It is internationally accepted that inspection will include some form of testing. It is obvious that analytical testing should be performed by a competent authority and it is to this end that the NRCS strives to provide direction to potential testing facilities which will state clearly the acceptance requirements for test reports or certificates. 2.4 Surveillance Surveillance inspections are planned, conducted and monitored in accordance with a risk based model that is based on the Pareto (80/20) principle to ensure efficient and effective utilization of resources. A team of inspectors are trained and if found competent are issued with inspection authorities. Inspectors have the authority to enter and inspect subject to the rules laid down in legislation. Where inspectors are prevented from conducting inspections, they may call on police officers for assistance. Power to entre private dwellings may only be possible through the obtaining of a search warrant. 2.5 Acceptable evidence of conformity Any manufacturer, builder or importer that offers a commodity or service for sale as contemplated in the Compulsory Specifications (VC) shall, when requested by the regulator produce the required evidence or as defined in a VC, produce such evidence of conformity.

7 Documented evidence must in all cases be traceable to a Conformity Assessment Body (CAB) as per the NRCS Conformity Assessment (AC) policy. The policy dictates that the NRCS will only use conformity assessment bodies that meet with the following competency criteria: a) Conformity assessment bodies shall demonstrate appropriate technical and proficiency skills for the assessment of the conformity of commodities or products with the requirements of compulsory specifications, and meet any additional specific requirements that the Regulator may prescribe. b) In addition the body shall meet with one of the following requirements in respect of competency to determine the conformity of commodities or products, with the requirements of a compulsory specification: i) Accreditation to ISO/IEC 17025, ISO/IEC and SANS as applicable, by SANAS or an ILAC or IAF affiliated organization; or ii) Successful peer review/mutual acceptance against the above requirements, acceptable to the Regulator; or iii) In the absence of evidence of appropriate accreditation, or successful independent peer review/mutual acceptance, the conformity assessment body shall provide satisfactory evidence of compliance with the requirements of ISO/IEC or ISO/IEC 17020, as applicable and that satisfies the Regulator. 2.6 An exception to the above occurs where South Africa is a signatory to an international agreement. The terms and conditions stated in such mutual acceptance arrangement, as to the acceptance of conformity assessment, shall be upheld by the NRCS. In the automotive industry South Africa is a signatory to the international agreement under the auspice of WP 29. WP 29 was originally known as the Working party on the Construction of Vehicles. Under the1958 agreement the parties entered into force the agreement on 20 June Through this agreement WP 29 became the appointed administrative body of the agreement. WP 29 currently administers 3 agreements operating in the following areas; - Pollution and energy - General safety provision - Brakes and running gear - Lighting and light-signaling - Passive safety and Noise 2.7 Conformity assessment bodies shall not use any recognition by the Regulator, or any other outcome arising from such recognition, for commercial purposes.

8 2.8 Risk to impartiality A reputable inspection body shall be responsible for the impartiality of its inspection activities and shall not allow commercial, financial or other pressures that will compromise impartiality. The inspection body shall identify any risk to its impartiality on an ongoing basis. This shall include those risks that arise from its activities, its relationships, or from the relationships of its personnel. However, such relationships do not necessarily present an inspection body with a risk to impartiality. A relationship that threatens the impartiality of the inspection body can be based on ownership, governance, management, personnel, shared resources, finances, contracts, marketing (including branding), and payment of a sales commission or other inducement for the referral of new clients, etc. Where a risk to impartiality is identified, the inspection body shall be able to demonstrate how it eliminates or minimizes such risk. It is essential that the top management of such an organization is commitment to impartiality. Annual risk audits shall also be done to ensure that possible risks to impartiality are timeously detected and addressed. 2.9 Sales permits An application for a sales permit directed to the NRCS with regard to a product or service and which do not comply or which does not fully comply with all the requirements of VC s may be considered for purposes of exempting the person to whom a permit has been issued from compliance with that VC. Applications for sales permits are issued taking cognisance of actual conditions e.g. plan of corrective action and timeframes. It is essential that a possessor of a sales permit be informed that should complaints regarding a product be received that the NRCS may consider the withdrawal of the permit The act further provides for the issue of permits for experimental type approval. These permits relates to products which have been manufactured in accordance with compulsory specifications or that complies with a VC. The permits are not required to be subjected to the same process as a sales permit Sanctions In the regulatory environment in modern society it would be ideal to strive towards full compliance with the absolute minimum intervention by regulatory structures. This unfortunately is not possible and it is therefor necessary to ensure a level playing field by introducing measures to sanction noncompliance in justified instances. To this end the enabling legislation provides for penalties where the governing rules are not adhered to. Offences and penalties range form the issuing of directives for purposes of preventing non-compliant products entering the market to an instruction to destruct or return it to country of origin. Fines may also be imposed by a court of law.

9 Directives are issued by the Chief Executive officer (CEO) or any staff member designated by him/her. Where item are found to be suspect or evidence of noncompliance is identified the CEO may issue a directive. A directive issued serves as an order to keep the affected products at a defined address and may thus not be sold. The effect of such directive ensures that the opportunity to provide the necessary evidence of conformity to the regulator. In the event of a failure to produce evidence of compliance, the matter is referred to the NRCS Board, and may order the destruction of the noncompliant products or, if imported, the return thereof to the country of origin. Penalties for offences in the event of a conviction by a court may result in a fine being imposed over and above the forfeiture of the goods in question. A court is entitled to increase the fine by an amount equal to the monetary value of any gain emanating from the sale of such goods. 3. Conclusion In conclusion it need to be emphasized that the overall mandate of the regulator is to protect the health, safety and the environment and it should be appreciated that this is no easy task. In the global arena competition is fierce and regulatory authorities increasingly need to develop modernized methods to ensure continued compliance. Regulatory affairs is not a money spinner in the true sense however, it adds a forth component to the scope of responsibility. This part deals with the locking in or out of commodities in economies and hampers fair trade in the spirit of the WTO agreement. Dealing with noncompliant products and services is part and parcel of a sound regulatory regime and requires competent and regular surveillance and monitoring of the market to ensure fair trade and compliance. The NRCS is no different as may be appreciated by the various memoranda of understanding developed and maintained with various governing departments. In the South African context this approach will certainly lead to a healthier situation in the creation of a culture of continued compliance. 4. References National Regulator for Compulsory specification Act, 2008 (Act5 of 2008) Government Gazette No dated 15 October (Regulations) United Nations 2002: World Forum for Harmonization of vehicle regulations. NRCS Policy on Conformity Assessment CPO : 2008

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