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Calibration and Testing Services, Consultancy and Learning
News Release from: SGS | Subject: Quality Management System
Edited by the Manufacturingtalk Editorial
Team on 15 December 2005
Supply chain quality management system
Taking the complex process of manufacture of electrical and electronic goods and products into consideration it becomes necessary to have an effective Quality Management System in place.
Taking the complex process of manufacture of electrical and electronic goods and products into consideration it becomes necessary to have an effective Quality Management System in place, able to manage the whole supply chain from raw materials to components and via the end-production stage to shipment Since the retailer importing the goods and products into the European Union becomes responsible for meeting all European Regulations (such as the RoHS Directive) applicable to the product in question, it is becoming even more important to have effective and adequate test and control mechanisms in place to ensure and to prove that the "imported product" meets all necessary requirements
This article was originally published on Manufacturingtalk on 28 Jun 2007 at 8.00am (UK)
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The objective of the SGS Modular RoHS Concept for Retailers/Importers is to take the above mentioned into consideration and to provide effective and adequate control mechanisms to ensure that the imported products meet the product specifications (agreed between the import organization and the manufacturer) and all necessary RoHS regulations from the European Union, such as RoHS Directive 2002/95/EC.
Furthermore this concept can be combined with all other regular inspection services and other services of the SGS Group worldwide, e.g Final Random Inspection (FRI), During Production Check (DuPro) or Quality/ Environmental Management System Certification.
The SGS modular RoHS concept consists to a great extent of three modules, each of which deals with specific items (risks) within the whole manufacturing process.
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The combination of various different modules enables the user to build his "tailor-made" Quality and Control System taking the actual (control) needs into consideration case by case.
The importer can decide whether he wants to have the full process controlled or just specific parts of the process.
Your benefits from the SGS RoHS modular concept: flexible and easy to adapt to the specific business needs; sufficient to control the manufacturing process; cost effective; delivers reliable and comparable results (all laboratories use the same test methods); available through the global SGS Network of Subsidiaries and Laboratories; is "tailor-made" for retailer/importer The three main (basic) modules of the RohS concept are: A.
Component (Material) Testing in chem.
SGS Laboratory.
B.
Technical Inspection/Screening.
C.
RoHS Factory Inspection/Audit Module Component (Material) Testing in chem.
Laboratory Module A follows the guidelines of the RoHS Directive 2002/95/ EC and requires chem.
Lab.
testing at "Homogeneous Material" Level.
The required tests shall be carried out by an experienced and accredited Laboratory following the test methods and guidelines of the Directive 2002/95/EC.
Most likely, the testing of basic components and materials will be handled by the supplier of the basic components and materials or by the end-product manufacturer himself, but typically not by the retailer/importer.
The test reports must be made available to the end product manufacturer and/or retailer/importer by the supplier of basic components and materials.
Without these test data and test reports, it is not possible to prove compliance with the RoHS Directive.
Therefore the retailer/importer must insist - by written contract, e.g within the agreed product specifications - on receiving information on and insight into all relevant product and production data.
Otherwise the goal of importing products in compliance with the regulations of the European Union RoHS Directive will not be achievable and the declaration of conformity will not be possible.
This would be a violation of European Regulations.
In the case of missing test data and test reports, or in the case of any uncertainty/doubts regarding the quality or source of important product documentation, the retailer/importer shall oblige the end product manufacturer to submit all test reports from his component/sub-assembly and/or material suppliers.
If important information (test reports) is still missing, the "unit" in question shall be tested at an accredited RoHS Laboratory chosen by the retailer/importer.
Module B Technical Inspection/Screening - Sample Test As opposed to Module A, Module B does not focus on the approach of having basic materials and/or components (testing of "Homogeneous Materials" as required by RoHS Directive 2002/95/EC) tested.
Module B starts one step later in the production process and directs its main focus on sub-assembled parts and final products, and the investigation and assessment of sub-assembled parts/final products.
The investigation method used in Module B is different to the one in Module A, since the investigation of sub-assembled parts may take place in a chem.
Testing Laboratory but it is also practicable in other locations, such as Warehouses, Customs, Ports or Production Plants.
Module B uses X-Ray Screening (portable test device) as a test method for detection and measurement of prohibited substances in electrical and electronic products and sub-assemblies.
The results, gathered using the X-Ray Screening method, are not as reliable as the methods used in Module A.
But the screening method is sufficient to determine, whether the product is free of forbidden substances or if forbidden substances are present in the product at significant concentrations/levels.
X-Ray Screening provides a so to speak "black or white / good or bad" statement combined with a test value for orientation (how good or how bad?).
The aim of the test method used in this module is; to provide quick test results for orientation; to keep the investigation costs as low as possible; to be independent from laboratory facilities The scope of the investigation and the number of points to be measured using the X-Ray Screening method is directly related to the complexity of the product in question.
The X-Ray Screening method is after all not a 100% reliable substitute for the testing method used in Module A.
The test method used in Module A is the only testing method referenced by RoHS Directive 2002/95/EC.
In the following, Module B is further split into different sub-categories, such a; B1.1: SGS sets scope of the investigation and defines measuring points, investigation at SGS Laboratory; B1.2: same as B1.1, but investigation not at SGS; B2.1: Retailer/importer defines scope of the investigation and defines measuring points, investigation at SGS; B2.2: same as B2.1, but investigation not at SGS The X-Ray Screening method of Module B includes a RoHS test report, which will be sent to the client within 2-3 working days; identifying the product/sub-assembly investigated referencing the test method used; listing and identifying all points of measurement; identifying all points of measurement by taking digital photos; listing the measured values for each point of measurement Module C: RoHS Factory Inspection / Audit Module C focuses on the production process and the influences of the production process on the end-product.
This module is not so much a "Laboratory Approach" as an ISO 9001/ISO 14001 oriented set-up combined with core safety elements of common CENELEC Factory Inspections.
The objective of Module C is to judge the capability of the end-assembly line (end-production line) to produce products, in full compliance with the requirements of RoHS Directive 2002/95/EC.
Module C investigates, but is not limited to, the following aspects and criteria of production: Organisation:Influence of the quality control (QA/QC) Control of subcontractors; how? Factory/end-assembly line responsible for product modifications? Internal approval system for modifications available? Will the client be informed about product modifications? Incoming Inspection: Who performs incoming inspection, QA/QC? Location/Work situation? Marking of RoHS relevant (critical) components and materials? Related to Constructional Data Format (CDF)? How is the inspection status marked? Are separate locations used for each inspection status? o How is the inspection performed? Which standard(s) is/are used? Checklist for RoHS approved components and materials available? Who decides about the checked items? Locations/Conditions (e.g inside/outside, secured) How are RoHS approved components, materials and sub-assemblies differentiated? How is the correct component/material/sub-assemblies flow in production guaranteed? Component/sub-unit assembly: Components/Manufacturer? a 100% Evidence of RoHS Conformity? Documentation available? Kind of documentation, e.g Test Records ? Production: Identification of RoHS relevant production stages? Working instruction available at all places? Trained personnel in production? Is a production control (line patrol) performed? Which traceability system is used to identify each unit later? Which product identifier (system) is used during the production? Sample Test before Shipment: Is QC/QA performing this test? Location / Conditions? andWhich standard(s) is/are used to perform the sample test before shipment? Lot size / Sampling rate? AQL Level? How often is a lot found to be out of specification? Reason(s)? How is/are rejected lot(s) handled? Repaired and completely re-tested? The elements included in but not limited to Module C can also be customized to meet the special needs of the retailer/importer.
Module C does not judge the safety relevant or performance aspects of a product leaving the end-assembly line.
It is purely focused on the important and relevant RoHS criteria.
Module C, combined with the previous modules A and B, controls the complete supply chain (line purchase), in order to judge the RoHS compliance of the goods imported by the retailer/importer into the European Union.
SGS is the most competitive and the most productive service organization in the world.
Our core competence in testing, inspection, verification and certification is being continuously improved to be best-in-class.
It is at the heart of what we are.
Our chosen markets will be solely determined by our ability to be the most competitive, and by our consistency in delivering unequalled service to our customers, both locally and transnationally.
Integrity is at the core of the business of the SGS Group, it is the common thread through all our activities.
The purpose of this Code of Integrity and Professional Conduct is to lay down our rules of behaviour in all our dealings for the SGS Group and to provide guidance in our day-today business.
These rules apply to all employees of the SGS Group.
Our joint venture partners, agents, intermediaries, consultants and subcontractors shall also be required to comply with them.
It is the responsibility of all of us, at all levels of our organisation, to comply with, and live by, our Code.
No deviation can or will be tolerated and no employee will suffer any adverse consequence for having complied with it or for reporting suspected violations. Request a free brochure from SGS ...
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