Signature Name & Designation RHMCO( ) Date: Recommendation and Points for Action:

Transcription

1 HM/AHC/F4.2 March 2011 ADEQUACY AUDIT REPORT OF QUALITY MANUAL OF A & H CENTRE AS PER IS 15820: Auditor's Name and Designation : 2. Date(s) of the Adequacy Audit : 3. Application No : 4. Name & Address of the A&H Centre : 5. Address of Offsite location (if any) : 6. Quality Manual as per ISS : 7. Quality Manual/Document(s) of Centre: i) Title: ii) Issue No. and date of issue, including : Number of amendments (if any): 8. Findings of Adequacy Audit : Annexure attached, duly filled-in 9. Whether nonconformities found : 10. Additional information, if any : 11. Recommendations : Signature Name & Designation RHMCO( ) Date: Recommendation and Points for Action: 1

2 ANNEXURE IS: Clause Requirements Reference to Cl. No. of firm s doc Complies (Yes/No) Details of Nonconformity, if any 4.1 MANAGEMENT REQUIREMENTS Organization a) Legal Identity (Registration with appropriate statutory body) and Independent Status. b) No Linkage with Jewellery Trade/Association c) Assaying and Hallmarking Activities meet the requirements of IS and Conformity with the needs of consumers, regulatory authorities and/or organization providing recognition d) Define organization and management structure e) Independent or part of organization performing activities other than assaying and hallmarking, if part of such an organization, responsibilities of key personnel who has/have an involvement or influence on assaying and hallmarking defined in order to identify potential conflicts of interest. f) Complete Assaying and Hallmarking facilities as per IS:1417,and IS :1418 or IS :2112,and IS : 2113,as applicable. g) Define responsibility, authority and interrelationship of all personnel, who manage, perform or verify work affecting quality of assaying and hallmarking. h) Managerial staff with authority and resources needed to discharge their duties specified. i) Adequate qualification and experience of staff to perform the duties assigned to them with respect to position. j) Provision for supervision by persons familiar with test methods, procedures, objectives and assessment of results. k) Appointment of quality manager and assaying in charge/ Technical manager l) Availability of deputies of key managerial personnel m) Protection of customer s confidential information and proprietary rights n) Personnel are free from commercial and other pressures p) Personnel are aware of relevance and importance of their activities 2

3 4.2 Management System a) Management system appropriate to assaying and hallmarking activities are established, implemented and maintained b) Policies, system, programmes, procedures and instructions are documented c) Quality policy is defined and documented, understood, implemented and maintained at all levels d) Commitment to the development and implementation of QMS and to continually improving its effectiveness e) Communication of the importance of meeting customer requirements as well as statutory and regulatory requirements f) Does the quality manual include or make reference to the supporting procedures including technical procedures. g) Does the quality manual outline the structure of the documentation used in the management system. 4.3 Document Control a) Procedures established to control all documents from receipt to delivery of work(internally generated and from external sources) such as regulations, standards, manuals etc. b) Documents reviewed and approved by authorized personnel before issue c) Availability of master lists of documents with current revision status and distribution d) Procedure adopted to ensure -availability of latest versions of applicable documents at points of use -Review / updation /re-approval of documents -Removal of invalid/ obsolete documents from the point of use to prevent unintended use and their identification -Retention of obsolete documents for specific purpose and its identification e) Unique identification of documents with revision, page no., total no. of pages, issuing authority etc f) Authority to change document indicating changes to documents shall be done by the same function unless specifically designated otherwise that performed the original review, g) Availability of procedures to describe how changes of documents in computerized system are made and controlled 3

4 4.4 Review request/contracts a) Procedure established to review request to ensure that hallmarking is done for jewellery/ artefacts offered by BIS licensees only, b) Availability of internet facility for ascertaining status of BIS licensees c) Ensure delivery of hallmarked jewellery within 48 hours d) Availability of the receipt of Jewellery/artifacts and reviews of requests ensuring the following points: -Request is from BIS certified licensee -Validity and scope pf licence held -Review of marking on the jewellery/artifacts -Quantity in numbers with declared fineness -Design for artefacts -Insurance of the jewellery/artefacts submitted for hallmarking purposes by the licensee -Capability in respect of availability of CRMs -Capability in respect of meeting delivery time schedule -Delivery mode and changes, if any and -Hallmarking charges applicable e) Ensure to take an undertaking from the jeweller declaring their identification mark as declared to BIS. f) Provision is made for assaying the jewellery/samples for common consumer on priority on chargeable basis 4.5 Subcontracting of tests - not permitted (any subcontracting done?) 4.6 Purchasing services and supplies a) Procedures established for purchase, reception and storage of reagents and laboratory consumable materials relevant for assaying and hallmarking. b) Verification or inspection of purchased material for its conformity with specified requirements c) Review and approval of purchase documents for their technical contents d) Records of evaluation of suppliers and list of approved suppliers 4.7 Service to the customers Feedback from customers sought and analyzed for improvement of costumer service and QMS 4

5 4.8 Complaints a) Procedure established for recording, investigation and resolution of complaints b) Corrective actions taken, if necessary, based on investigation and analysis. c) Records of complaint, investigation and corrective action taken,if any d) Time frame for resolution to the complaint and intimation to BIS in case period of resolution of complaint is more than one month e) Procedure for audit of area of activity and responsibility on which doubts raised through a complaint or other circumstances. 4.9 Control of non-conforming testing work a) Procedures established for the management of non-conforming work and procedures to ensure that : - responsibility and authorities are defined to handle non-conforming work - an evaluation of the significance of the non-confirming work is made - correction is taken immediately, together with any decision about the acceptability of the non-conforming work - where necessary, the customer is notified and work is recalled; and - responsibility for authorizing the resumption of work is defined - corrective actions when evaluation of non-conforming work indicates it may re-occur b) Professional indemnity insurance For minimum Amount of Rs.2 lakh 4.10 Improvement - System in place for continual improvement of the effectiveness of its management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review 4.11 Corrective action Documented procedure and appropriate authority for implementing corrective actions which includes: a) investigation to determine the root cause or potential cause of the problem b) identification of possible corrective actions and their implementation c) documentation & implementation of any required change d) monitoring of results to ensure effectiveness of corrective action 5

6 4.12 Preventive Action - documented procedure for preventive action including initiation of actions and application of controls to ensure their effectiveness. - ensure identification of areas needed improvement - ensure identification of potential sources of nonconformity - ensure development of action plans its implementation and monitoring to prevent occurrence of non-conformities 4.13 Control of records - Procedure shall be established for identification, collection, indexing, access, filing, storage, retrieval, maintenance and disposal of records - Ensure that records are legible, stored and retained in such a way that they are readily retrievable and also ensure a suitable environment to prevent damage or deterioration and to prevent loss. - Provision to hold all records secure and in confidence - Procedures shall be made to protect and back-up records stored electronically and to prevent unauthorized access to or amendment of these records. Period shall be defined to retain technical records for - original observation - derived data and sufficient information to establish audit trail - calibration - staff record - copy of each test report issued - identification of personnel responsible for receipt, sampling, assaying, hallmarking and delivery observation data, and calculations Ensure that when mistakes occur in records, each mistake be crossed out, not erased, made illegible or deleted, and the correct value entered alongside and such alterations to records be signed or initiated by the person making the correction. Ensure no loss or change of original data,, in case records are stored electronically. Provisions of retention all records for a period of three years shall be made 4.14 Internal Audits - Procedure and periodicity (preferably twice a year) shall be made to conduct Internal Audits addressing all activity of centres - Timely corrective action in case of doubt on validity or correctness of results reported by centre to costumer and follow up audit of activity - Verification of implementation and effectiveness of the corrective taken 4.15 Management Review - Management Review shall be periodically conducted (preferably twice a year) - Review should take into account of points specified in IS: Records of management review meeting, findings, actions - Actions within agreed time period 6

7 Technical Requirements Ensure control on requirements of human factors, accommodation and environmental conditions, test methods, equipments measurements traceability, sampling, handling of jewellery/artifacts Personnel : - Competence of personnel ensured through qualification, training, technical knowledge and experience for their assigned functions. - assay in-charge qualification and training - procedure for identification of training needs and provide training - job descriptions for managerial,technical and key support personnel - personnel to perform sampling, to issue test reports, to give opinions and interpretations and to operate particular types of equipment are authorized - Record of authorization, competence, qualification, training, skills experience etc. - Professional secrecy by personnel ensured Accommodation and Environmental conditions a) Monitoring and control arrangement, with due attention to the following : - Dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, and sound and vibration levels in microbalance.xrf machine and laser marking machine rooms as appropriate. -Proper exhaust arrangement for furnaces and parting chamber. - Proper treatment of exhaust fumes before discharge into the atmosphere. - Un-interrupted power supply arrangement power back up arrangement b) Effective separation between neighbouring areas in which there are incompatible activities especially the assaying lab and microbalance from received/delivery area, sampling and hallmarking activity. c) Access to and use of areas effecting the the quality of the test d) Good House keeping ensured 7

8 5.4 a) Test Methods - Detailed procedures are established for Inspection and controlled movement of jewellery/artefacts at various stages, that is : - Receiving - Preliminary examination for homogeneity check and segregation - Sampling - Assaying - Hallmarking - For correct marking and any damage incurred - Packing and return of cornets, if any; and - Final dispatch/delivery b) Arrangement for carrying out preliminary examination by XRF method for homogeneity check and segregation c) Arrangement for verification for the presence of prohibited elements/metals such as cadmium, ruthenium and Iridium in gold articles/artefacts as per IS 1417 and lead and cadmium in silver articles/artefacts as per IS 2112 by XRF method. d) Assaying To be carried out as per relevant ISS e) Control of Non-conforming Articles - Documented procedure for identification and segregation of Non-conforming articles at preliminary XRF Stage and before marking - Ensure that responsibility for review and Authority for the disposition of non-conforming product are identified. - Hallmarking by Laser marking machine with inbuilt security and as per design /orders provided by BIS f) Hallmarking - Documented procedure for hallmarking by Laser marking machine with inbuilt security and as per design /orders provided by BIS - Permissible Sizes of hallmarks as per clause of IS marking on all detachable parts - vigilance on use of laser marking machine through password - Ensure maintenance of record (hard or soft copy) of laser marking done for different BIS licensees. g) Control of data - check on calculation and data transfer is ensured In case automated equipment are used for acquisition, processing, recording, reporting, storage etc., system to ensure that - software are validated - procedure are established and implemented for protecting data - Maintenance schedule of computer & automated Equipment to ensure proper functioning & Maintaining integrity of test data. 8

9 5.5 Equipment - centre shall have all the equipment as per relevant IS - equipment and reference material are calibrated/verified with traceability - established procedure for safe handling, transport, storage, use and planned maintenance for equipments - equipment shall be labeled or to be identified to indicate status of calibration/recalibration. - intermediate checks on calibrations as per defined procedure and use of correction factors is taken care of - test equipments ( both hardware and software ) are safeguarded from adjustments which may invalidate the test results 5.6 Measurement Traceability - established programme for calibration and verification of test equipment/instruments - calibrations are traceable to National/International standards - traceability of Reference Material to National/International Standards - records of receipt, consumption,testing of reference materials with identification and traceability - check of XRF with CRM before use - check of microbalance before use Intermediate Checks Ensure intermediate checks to maintain confidence in the calibration status of XRF machine and microbalance according to defined procedures and schedules. Ensure that guidelines as given in relevant IS are followed for verification/calibration of equipments and availability of certified reference materials ( CRMs) 5.7 Sampling -Sampling as per BIS approved sampling plan in Annex D and Guidelines for sampling in Annex E of IS Documented instructions for sampling using sampling tool as per IS 1418 & IS 2113 (as applicable) -Records of sampling procedure, identification of samples and sampling personnel, environmental conditions etc - System of samples traceability with its lot and test result 9

10 5.8 Handling of Test Items -centre shall have procedure for receipt, handling, protection, storage, retention and/ or disposal of jewellery/artefacts -system to identify jewellery artefacts and samples at all stages including assaying. -Record for receipt of jewellery/ artefacts with abnormalities and departure from normal,if any and discussion with customer for further action. -Security of all jewellery / artefacts shall be ensured from receipt to delivery - Availability of safe for secured storage of articles. - Security system at centre with CCTV/motion picture Detection system or any other suitable mechanism -Final packaging with identity for un-assayed, rejected and hallmarked articles and cornets -centre shall take insurance for jewellery/artifacts under process and equipments for minimum amount of Rs. 10 lakh. 5.9 Assuring the Quality of Test results:- -centre shall have quality control procedures for monitoring of validity of tests -Regular use of certified reference materials -Participation in inter laboratory comparison or proficiency testing programmes -Repeat tests using the same method. -Analysis of quality control data to prevent reporting and deviation from pre-defined criteria Reporting of Results - Test report as per information given in IS 1418/IS The report shall includes absence/ presence of prohibited elements 10

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