Form 48B. Assessment Checklist. ISO/IEC General Accreditation Requirements

Transcription

1 ISO/IE - Assessment hecklist Form 48B Assessment hecklist ISO/IE General Accreditation s Laboratory Information ompany Name Trident Systems & Engineering (TSE) Laboratory Location(s) 2646 Palma Dr. Ste 130 Ventura A ompleted By / Date harles S Sharp Assessor Information Assessor Name(s) harles S Sharp Assessment Type Annual Date of Assessment 23 December 2015 This checklist is to be used as part of the L-A-B General Accreditation s. This checklist includes the requirements of: o ISO/IE : General s for the ompetence of Testing and alibration Laboratories; The requirements identified within this checklist are summarized from the referenced standards. Form 48B - Rev 3-04/04/14 Page 1 of 40

2 ISO/IE - Assessment hecklist ompliance N N/A omments on ompliance 4 Management s 4.1 Organization Entity is legally identifiable? QAM sec Does entity conduct activities to be compliant with, the needs of the client, regulators, or recognition bodies? Does the management system cover all work, including permanent location, and on-site, mobile or temporary facility? Is the organization structure defined in order to identify potential conflicts of interest? The laboratory shall: QAM sec QAM sec Sole proprietorship, harles S Sharp dba Trident Systems & Engineering licensed for business in the State of alifornia. meets the requirements of ISO/IE and/or NSL Z540-1 and our quality manual, it satisfy the needs of our ustomer and/or organizations providing authorization and/or accreditation We perform some performance evaluations of measuring and testing devices at sites that are outside the permanent laboratory facilities. These sites are located at the owner s facility and may be either within a building or outdoors no accredited on-site work performed we have 3 levels of service NIST cal, Z540 cal, cal. QAM sec Organizational structure is defined No conflicts Provide personnel with the authority and Management and technical personnel of TSE are a) resources to carry out their duties. Including the equipped with the authority and resources to QAM sec 5.3 implementation, maintenance and improvement perform their duties and are aware of the of the management system. importance of their activities. b) Have provisions to assure that staff is free from QAM sec 5.4 Management ensures that TSE is independent from Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 2 of 40

3 ISO/IE - Assessment hecklist c) d) undue internal and external pressures. Have policies and procedures to protect the client s confidential information and proprietary rights. Have policies and procedures to avoid involvement in activities that diminish confidence in competence, impartiality, judgment or operational integrity. QAM sec 5.5 QAM sec 3.0 ompliance N N/A omments on ompliance any pressures commercial, financial, or others, which adversely affect the quality of test and resulting reports TSE maintains the confidentiality and proprietary rights of all information, including the type of work performed and the results of tests to the extent allowable by law and in accordance with the administrative procedures. (See Appendix H, AP No. 1, Procedures for ustomer onfidentiality and Proprietary Rights.) It is the policy of TSE to avoid involvement in activities that diminish confidence in competence, impartiality, judgment or operational integrity. Procedure is that employees report any breeches e) f) Define the organization and management structure. Specify the responsibility, authority and interrelationships of all personnel affecting quality of work. Signed conflict policy in place. QAM sec 5.0 Organizational Structure - OK QAM sec 5.0 Defined in Quality Management System g) Provide adequate supervision. QAM sec 5.0 Lab manager supervises h) Have a technical manager. QAM sec harles S Sharp i) Have a quality manager (however named) who is responsible for the quality system. QAM sec harles S Sharp Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 3 of 40

4 ISO/IE - Assessment hecklist ompliance N N/A j) Appoint deputies for key managerial personnel. QAM sec 5.0 had Sharp k) Ensure that personnel are aware of the importance of their activities. Top management shall ensure that communication processes regarding the effectiveness of the management system are established. 4.2 Quality System QAM sec 5.3 No 5.3 in QAM QAM sec 5.0 omments on ompliance A Management Review is held annually with all Management and Technical personnel The laboratory shall establish, implement and maintain a quality system appropriate to its scope of activity and communicated, understood, available and implemented by appropriate personnel. QAM sec3.0 / 6.0 Quality Management System is appropriate to size of lab The laboratory's management system policies related to quality, including a quality policy statement, shall be defined in a quality manual (however named). The overall objectives shall be established and reviewed during management review. A quality policy statement shall be issued under the authority of the chief executive and shall include: QAM sec 6.0 / 3.0 Defined in QAM QAM sec QAM sec harles S Sharp The objective of our quality manual is to establish a documented quality system that provides for continuous improvement of that quality system to ensure reliable and accurate test results Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 4 of 40

5 ISO/IE - Assessment hecklist ompliance N N/A omments on ompliance a) Management s commitment to good professional practice and quality of its tests and calibrations. QAM sec 3.0 Our policy is to provide the highest reasonable quality performance evaluation services attainable to ustomers through continuous improvement of the quality system b) Laboratory s standard of service. QAM sec 3.0 Quality in our services is a constant effort and focus. c) d) e) The purpose of the management system related to quality. that personnel familiarize themselves with the quality documentation and implement the policies and procedures in their work. Management s commitment to compliance with and continually improving the effectiveness of the management system. QAM sec 3.0 Quality in our services is a constant effort and focus. QAM sec TSE personnel who perform performance evaluation testing are familiar with the quality documentation, which is implemented in their work, policies and procedures QAM sec 3.0 continuous improvement of the quality system Top management shall provide evidence of commitment toward continually improving the effectiveness of the management system. QAM sec ommitment to Improvements are recorded and defined in our Management Review Top management shall communicate the importance of meeting customer, statutory and regulatory requirements. The quality manual includes or makes reference to supporting procedures, and outlines the structure of the documentation used. QAM sec 4.0 On SO for each job - OK QAM sec Various citations noted - OK Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 5 of 40

6 ISO/IE - Assessment hecklist The quality manual shall define the roles and responsibilities of the technical and quality managers for ensuring compliance with. The integrity of the management system must be maintained by top management when changes are made. 4.3 Document ontrol ompliance N N/A QAM sec 5.0 / 7.0 Defined in QAM QAM sec omments on ompliance It is the Policy of TSE that the integrity of the management system is maintained by top management especially when changes are made Have procedures to control all documents that form part of its quality system, both internal and external documents. NOTE This includes L-A-B Policies and L-A-B Manual 003 General Accreditation s QAM sec 6.0 AP No. 3, Document ontrol Adequate Document Approval & Issue Documents issued as part of the quality system are reviewed and approved by authorized personnel. Have a master list or equivalent identifying the current revision and distribution of documents. QAM sec 6.1 QAM sec appendix N All documents are reviewed and approved for use by authorized personnel prior to issuing the document to personnel in the laboratory Appendix N show current revisions and a verification date. with links to the L-A-B website and current documents The procedure shall ensure: Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 6 of 40

7 ISO/IE - Assessment hecklist a) b) c) d) Authorized editions of documents are available, where necessary, for the effective functioning of the laboratory. Documents are periodically reviewed and revised as necessary to ensure continued suitability. Invalid and obsolete documents are promptly removed from service, or assured against unintended use. Obsolete documents retained are suitably marked. Management system documents generated are uniquely identified. Shall include dates, revisions, page numbers, total number of pages, issuing authorities. QAM sec 6.1 / c QAM sec QAM sec e QAM sec f QAM sec ompliance N N/A omments on ompliance assurance that authorized editions of appropriate documents are available at all locations that are essential to the proper functioning of the laboratory periodic review and, as necessary, revision of the documents to ensure suitability Last review 12/5/2015 removal of invalid or obsolete documents removal of invalid or obsolete documents Appendix N provides a list of controlled documents. The procedures for document control includes information on document control numbers Document hanges hanges shall be reviewed and approved by the same function. The designated person shall have access to background information. Altered or new text shall be identified, where possible. Hand amendments shall be clearly marked, initialed and dated. The new document shall be issued ASAP. QAM sec QAM sec QAM sec Document changes are reviewed and approved following the same procedures for the original review process hanges in electronic documents are tracked by the word processing system and are accepted by authorized laboratory staff Handwritten changes to hard copy documents are clearly marked, initialed and dated by laboratory staff authorized to make changes to the documents Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 7 of 40

8 ISO/IE - Assessment hecklist omputerized maintenance for documents shall be established in a procedure. 4.4 Review of requests, tenders and contracts Policies and Procedures for review of requests, tenders & contracts Policies and procedures for review shall ensure: a) s are adequately defined, documented and understood. ompliance N N/A omments on ompliance QAM sec Procedure in place - checked - OK 12/5/2015 QAM sec 4.0 b) Lab has the capability and resources. QAM sec 4.2 c) Appropriate method is selected and can meet the client s requirements. Differences between request or tender and the contract shall be resolved. ontracts, tenders, and work requests received by TSE are in the form of request for calibration. alibration request are received by the Operation manager. Procedure in QAM QAM sec 4.1 The type of calibration is understood QAM sec 4.2 QAM sec TSE is capable of meeting the requirements and has the necessary resources for accepted request TSE cooperates with the ustomer to ensure that the application is understood. TSE calls the ustomer upon receipt of equipment and or the PO and reviews the application with the ustomer Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 8 of 40

9 ISO/IE - Assessment hecklist ompliance N N/A hecked records omments on ompliance Records of reviews are maintained. Records of pertinent discussions with clients are maintained. AP no. 22 Ref No Dec OK Recall notices Various checked Dec 2015 OK Recall notices have been modified to include the type of calibration NIST cal, Z540 cal, or cal Review shall include subcontracted work. QAM sec The ustomer is informed of any subcontracted work is to be done and a formal document is presented to the ustomer for approval before it is accepted lient informed of deviation from contract. QAM sec 4.1 ustomer discuss any abnormalities ontracts amended after work starts must have the same review as the original. 4.5 Subcontracting of Tests & alibrations QAM sec 4.2 Repairs checked - OK Subcontracted work is placed with a competent subcontractor. lient is advised in writing of the intention to subcontract, and where necessary gain client approval. QAM sec 15.0 QAM sec Subcontracting is only conducted with the OEM or authorized laboratories capable of performing the Performance Verification. TSE is responsible for the subcontractor s work and notifies the ustomer of the arrangements for subcontracting Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 9 of 40

10 ISO/IE - Assessment hecklist Lab is responsible for the subcontractor s work, except where the client specifies the subcontractor. An approved subcontractor list, and evidence of compliance with exist for all subcontractors. QAM sec 15.2 Approved Vendors list in audits K1990 ompliance N N/A omments on ompliance TSE maintains a list of all subcontractors used by the laboratory, along with evidence of their compliance to the laboratory s quality system 4.6 Purchasing Services and Supplies Have policies and procedures for purchase of services and supplies. Also for purchase, reception and storage of reagents and laboratory consumable materials. Purchased supplies and reagents and consumables are inspected or otherwise verified prior to use. Records of such actions are recorded. QAM sec 16.0 AP no. 9 QAM sec 16.0 AP no. 9 TSE uses services and supplies of adequate quality where the specifications of outside services and supplies are relevant to the integrity of tests AP No. 9 Procedure - OK Access database updated with info from accredited cal provider checked records for 4808 Precision Metrology ompliant Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 10 of 40

11 ISO/IE - Assessment hecklist ompliance N N/A PO s checked omments on ompliance Purchasing documents shall contain data describing the services and supplies ordered and be reviewed and approved for technical content prior to release. QAM sec 16.0 AP no. 9 Precision Metrology 4808, 12 month cal cycle, before / after data OK Keysight 3458A -, 12 month cal cycle, before / after data OK Accurate Instruments - Gage Blocks , 12 month cal cycle, before / after data OK Suppliers of critical consumables, supplies and services shall be evaluated, and records of the evaluations and a list of those approved maintained. QAM sec 16.0 AP no. 9 Approved vendor list The records of the evaluation were updated 12/5/ Service to the lient Afford clients cooperation to clarify request and monitor performance in relation to the work performed by the lab, provided confidentiality of other clients is maintained. QAM sec TSE works with the ustomer to clarify test requests, device operation and test results The laboratory shall seek positive and negative feedback from its clients for improvement of the management system, laboratory activities and customer service. QAM sec / 17.0 AP no. 6 AP no. 10 and customer surveys Survey form in place Negative feedback recorded as complaints 4.8 omplaints Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 11 of 40

12 ISO/IE - Assessment hecklist 4.8 Policies and procedures shall exist for handling complaints. QAM sec 17.2 AP no. 6 AP no. 10 AP no. 16 ompliance N N/A omments on ompliance Policy - Lab Manager will be responsible for the handling of customer complaints, and with the help of any or all of the staff to find a solution to the problem complaint and solution are documented in 96so database and filed 4.8 Records of complaints and their investigations and corrective actions shall be maintained. QAM sec 17.2 AP no. 6 AP no. 10 AP no so omplaints log complaints 4.9 ontrol of Nonconforming Work Policies and procedures shall be implemented when work or the results of work do not conform to its own procedures or the requirements of the client. QAM sec 9.0 / 14.0 / 16.0 AP no. 18 AP no. 14 Any alibrated Equipment or Measurement Standard that is Out of Tolerance By 25% over the rated accuracy will be considered to be Significantly Out of Tolerance. ontrol of Non-conforming Work - AP No The policies and procedures shall ensure: a) Responsibility and authority for handling of nonconforming work are designated, and actions are defined and taken when nonconforming work is identified. AP no. 14 / 18 delegated to the appropriate management authorities Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 12 of 40

13 ISO/IE - Assessment hecklist b) c) d) e) Evaluation of the significance of the nonconformance. orrection is taken immediately, together with any decision about the acceptability of the nonconforming work. Where necessary, the client is notified and work recalled Responsibility for authorizing the resumption of work is defined. If nonconformance can recur, or doubt about compliance of the lab s operations with its own policies and procedures exists, corrective action IAW 4.11 shall be promptly followed. AP no.14 / 18 AP no14 / 18 AP no. 14 /18 ompliance N N/A omments on ompliance Identified non-conformances with any procedure, quality control parameter or customer requirement are documented and the TSE s corrective action is initiated. This process involves the evaluation of the impact on quality and operations When a non-conformance is detected, TSE's data is held and not released until the problem is resolved and verified by laboratory management Resumption of work is performed after the corrective action has been taken and approved. If required the customer is notified and any UUT impacted is recalled AP no. 14 QA Manager has sole responsibility AP no. 6 ompliant as reviewed 4.10 Improvement 4.10 The laboratory shall use the quality policy and objectives, audit results, data analysis, corrective and preventive actions and management review to improve its management system. QAM sec 3.4 TSE uses the quality policy and objectives, audit results, data analysis, corrective and preventive actions and management review to improve its management system 4.11 orrective Action Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 13 of 40

14 General ISO/IE - Assessment hecklist ompliance N N/A omments on ompliance Establish policy and procedure and designate authorities for implementing corrective action. QAM sec 17.0 AP no. 6 / 10 TSE promptly investigates complaints, adverse findings during audits, or any other circumstance that raises doubts concerning the laboratory's competence or compliance with required procedures AP No 6 - Preventive / orrective Action / Feedback ause Analysis (A) Investigate to determine root cause. AP no Selection and Implementation of orrective Action. Identify, select and implement appropriate corrective action that is likely to prevent recurrence. A is appropriate to the magnitude and risk of the problem. Document and implement changes resulting from A Monitoring of A AP no. 6 AP no. 6 ompliant as reviewed AP no. 6 ompliant as reviewed AP no. 6 ompliant as reviewed The "omplaints data base" includes root cause field for recording the results of the investigation ompliant as reviewed The "omplaints data base" includes orrective Action field for recording the results of the Implementation of the A ompliant as reviewed Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 14 of 40

15 ISO/IE - Assessment hecklist ompliance N N/A Monitor A to ensure that it is effective. AP no Additional Audits Where nonconformance s or departures cast doubts on compliance with policies, procedures, or, the area of activity is audited per 4.14 ASAP. QAM sec 17.0 AP no. 16 Effective implementation of orrective Actions from previous assessment or surveillance, if applicable. omments on ompliance The "omplaints data base" includes QA check box for recording the QA managers compliance ompliant as reviewed ompliant as reviewed hecked 1 from previous assessment Implemented adequately Preventive Action Improvements and potential non-conformances shall be identified. When opportunities for improvement are identified or action is required, plans shall be developed, implemented and monitored to reduce the likelihood of occurrence. Procedures shall include initiation of actions and controls to ensure they are effective. QAM sec 17.1 AP 6 - Preventive / orrective Action / Feedback AP no. 6 ompliant as reviewed AP no. 6 ompliant as reviewed 4.13 ontrol of Records General Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 15 of 40

16 ISO/IE - Assessment hecklist Establish and maintain procedures for handling of quality and technical records. Records shall be legible and stored to be readily retrievable in suitable environments to prevent damage, deterioration or loss. QAM sec 13.0 AP no. 22 QAM sec 13.0 AP no. 22 ompliance N N/A Retention times established. AP no. 22 omments on ompliance TSE maintains procedures for the identification, collection, indexing, access, filing, storage, maintenance and disposal of administrative and measurement-related records. (See Appendix H, AP No. 22.) All records are readily retrievable and maintained in a suitable environment Manufacture manuals are kept in the library minimum of two years ompleted Documents stored in filing cabinets for a minimum of two years after which it is put into filing boxes and for a minimum of fifteen years Records held secure and in confidence. AP no. 22 ompliant as reviewed Electronic documents / records are kept for minimum of two years Procedures to protect and back-up electronic records and prevent unauthorized access. AP no. 22 ritical data bases (TSE1.accdb, tse.qbw)are backed up daily All other files are backed up weekly and stored in fire proof containters Technical Records Retain sufficient records to establish an audit trail of work for a defined period. QAM sec 13.0 / 14.0 AP no. 22 ompliant as reviewed Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 16 of 40

17 ISO/IE - Assessment hecklist Observations, data and calculations shall be recorded at the time they are made and be identifiable to the specific task. Mistakes are single-line crossed out, correct entry made, and signed or initialed by person making correction. Electronic records shall be handled to prevent loss of original data Internal Audits ompliance N N/A QAM sec 13.2 ompliant as reviewed QAM sec 13.2 omments on ompliance ompliant as reviewed Internal audits are conducted monthly to verify that operations continue to comply with the quality system. QAM Schedule and procedure for periodic audits of lab s activities that addresses all elements of and the quality system by trained and qualified personnel. QAM sec 6. AP no. 7 Procedure - Each area and activity is audited at least once per year and recorded in J TSE PT and Internal Audit Tracking file al witnessing procedure SOI QA 1002 Technical witnessing procedure SOI QA Technical witnessing activities performed monthly ompliant 12 al witnessing activities performed monthly ompliant Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 17 of 40

18 ISO/IE - Assessment hecklist When findings cast doubt on operations or validity of results, the lab shall take corrective action and notify clients in writing if investigations show results may have been affected. AP no. 7 ompliance N N/A omments on ompliance None raised during IA activities ompliant as reviewed The audits, findings and A shall be recorded. AP no. 7 None raised during IA activities Follow-up activity shall verify and record implementation and effectiveness of A Management Review In accordance with a predetermined schedule and procedure; periodic review of the quality system and testing/calibration activities to ensure their continued suitability and effectiveness, and to introduce changes or improvements Review shall include: AP no. 7 None raised during IA activities QAM sec 6.4 Laboratory Manager conducts annual management reviews of the quality system Procedure in place OK Scheduled for 18 Dec Suitability of policies and procedures. AP no. 7 Addressed in 2015 review Reports from managers and supervisors. AP no. 7 Addressed in 2015 review Outcome of recent internal audits. AP no. 7 Addressed in 2015 review orrective and preventive actions. AP no. 7 Addressed in 2015 review Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 18 of 40

19 ISO/IE - Assessment hecklist ompliance N N/A omments on ompliance Assessments by external bodies. AP no. 7 Addressed in 2015 review Results of interlaboratory comparisons or proficiency tests. AP no. 7 Addressed in 2015 review hanges in volume and type of work. AP no. 7 Addressed in 2015 review lient feedback. AP no. 7 Addressed in 2015 review omplaints. AP no. 7 Addressed in 2015 review Recommendations for improvement. AP no. 7 Addressed in 2015 review Other relevant factors including Overall Objectives from Records of findings and actions that arise from the Management Review. Management ensures that actions are carried out in a timely fashion. 5.0 Technical s 5.1 General AP no. 7 Addressed in 2015 review AP no. 7 Addressed in 2015 review Personnel Many factors determine correctness and reliability. Extent to which factors contribute to total uncertainty differs considerably between tests and calibrations. ompliant as reviewed ompliant as reviewed Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 19 of 40

20 ISO/IE - Assessment hecklist Ensure competence of all who operate equipment, perform test/calibrations (t/c), evaluate results & sign reports/certificates. QAM sec 7.0 AP no. 17 ompliance N N/A omments on ompliance Members of TSE staff are selected for employment based on their professional qualifications, including education and relevant experience AP 17 - Training / Qualifications Formulate goals for education, training and skill of personnel. AP no Evaluation of the training actions effectiveness. AP no Policy and procedure to identify relevant training needs and provide training of personnel. Shall use personnel employed by or contracted to the laboratory. Where contractors or additional key personnel are used, the lab shall ensure supervision to evaluate competence of work. Maintain current job descriptions for managerial, technical and key support personnel. TSE Manager with the assistance of the QA manager Formulates goals for education, training and skill of personnel AP no. 17 ompliant as reviewed AP 17 QAM sec QAM sec / Personnel who are in the process of training are supervised until training is completed. ontracted personnel are also trained or experienced in testing measuring and testing devices Defined in QAM Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 20 of 40

21 ISO/IE - Assessment hecklist ompliance N N/A omments on ompliance Training records checked had Sharp OJT and attendance certificates for various classes attended changes to systems Scales Fluke webinars Uncertainty of measurement MS conference Up to date Authorize and maintain records of such authorization for personnel to perform particular tasks. AP no. 17 Appendix L QAM sec AP no. 26 Jose Dionicio OJT up to 2008, RF and microwave fundamentals, various training classes from Fluke Temperature, DMM, Ring gages, ESD certified, IR Thermometers, RF Microwave Up to date Victor Arevalo OJT training up to 2008, Gage black class, Torque wrench, Micrometer, Pin gages Up to date. Authorizations for had and harles Sharp to issue certificates AP No Shall maintain records of competence, educational and professional qualifications, training, skills and experience. Information shall be readily available. AP no. 17 Appendix L Records checked - omplaint 5.3 Accommodation & Environmental onditions Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 21 of 40

22 ISO/IE - Assessment hecklist Facilities shall facilitate correct performance of t/c. Monitor, control and record environmental conditions where necessary to maintain quality of t/c. Effective separation between areas that are incompatible and to prevent crosscontamination. QAM sec 8.0 AP no. 11 Appendix E QAM sec Appendix D ompliance N N/A omments on ompliance Electrical Standards Lab Temperature 23 +/- 5 degrees Relative Humidity is maintained between 30-80% Physical Dimensional Standards Lab Temperature 20 +/- 3 deg. Relative Humidity is maintained between 30-80% ontrol ompany 6050 Temp/Humidity data loggers ompliant as reviewed ompliant as reviewed Access to controlled areas limited. QAM sec 18.2 ompliant as reviewed Good housekeeping ensured. 5.4 Test & alibration Methods and Method Validation QAM sec AP no. 11 ompliant as reviewed General The laboratory shall use appropriate methods and procedures. QAM sec 11 TSE selects test procedures that are appropriate for the device under test, and the appropriate edition of the procedure is used to test the device. Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 22 of 40

23 ISO/IE - Assessment hecklist Instructions on use and operation of all equipment and handling and preparation of t/c items, where absence would jeopardize results. Instructions, standards, manuals, and reference data available where necessary Selection of Methods Use appropriate t/c methods, preferably international, regional or national standards. Ensure use of latest valid edition of standards, unless it is not appropriate or possible to do so. Laboratory shall select appropriate published methods when client has not specified method. Laboratory methods or methods adopted may be used if appropriate for the intended use and validated. lient informed of method selected. onfirm that it can perform standard methods before introducing the t/c. If standard method changes, confirmation shall be repeated Laboratory-developed Methods QAM sec 11 AP no. 14 pg 8 ompliance N N/A AP no. 14 ompliant as reviewed AP no. 14 QAM sec 11 AP no. 14 pg 8 QAM sec 11.2 AP no. 14 QAM sec 11.2 AP no. 14 QAM sec 11 AP no. 14 omments on ompliance Equipment manuals, operating instructions, reference data, specifications, and tolerance tables relevant to TSE are maintained in The laboratory and are readily available. When documented or published procedures are unavailable, or when deviations from documented procedures occur, procedures for a specific test are developed, validated, and agreed to by TSE and all concerned parties. ompliant as reviewed ompliant as reviewed ompliant as reviewed ompliant as reviewed Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 23 of 40

24 ISO/IE - Assessment hecklist When necessary to use methods developed by the lab, the activity is planned and development assigned to a qualified person equipped with adequate resources. Plans shall be updated and communicated to personnel involved Non-standard Methods Subject to agreement with the client, and include a clear specification of client s requirements and purpose. Method shall be validated Validation of Methods QAM sec 11 AP no. 14 AP no.15 AP no.19 QAM sec 11 AP no. 14 AP no.15 AP no.19 ompliance N N/A omments on ompliance ompliant as reviewed ompliant as reviewed AP no. 19 ompliant as reviewed Validation Definition Validate non-standard and laboratory-developed methods, those used outside their intended scope and amplification or modifications of standards methods, to confirm fitness for use. The range and accuracy of the values obtainable from validated methods shall be relevant to the client s needs Estimate of Uncertainty of Measurement alibration laboratories or test laboratories performing their own calibrations shall have and apply a procedure to estimate uncertainty. QAM sec 11.2 QAM sec 11.2 ompliant as reviewed Before a new test is conducted, TSE reviews the test procedure to ensure that the test can be performed adequately. If the test procedure is revised, the review is repeated. QAM sec NIST TN 1297 and MS T Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 24 of 40

25 ISO/IE - Assessment hecklist Testing laboratories shall have and where necessary apply procedures for estimating uncertainty. All uncertainty components are taken into account ontrol of Data ompliance N N/A NA Not a test lab QAM sec ompliant as reviewed omments on ompliance alculations and data transfers shall be checked. QAM sec 11.5 ompliant as reviewed a) b) c) When computers or automated equipment are used, the lab shall ensure that: Developed software is documented and validated. Procedures are established and implemented for protection of data. omputers and automated equipment are properly maintained and in an environment that ensures proper functioning. 5.5 Equipment Lab is furnished with all items of equipment required for correct performance of t/c. QAM sec UB sheet E = mc^3 developed - omplaint QAM sec ompliant as reviewed QAM sec ompliant as reviewed QAM sec 9 AP no. 13 Laboratory standards, equipment, and associated apparatus are maintained suitable for the correct performance of tests and are maintained in accordance with TSE procedures (see Appendix H, AP No. 13), equipment maintenance and operational manuals, and this quality manual. Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 25 of 40

26 ISO/IE - Assessment hecklist Equipment outside its permanent control shall be controlled to meet. Equipment and software shall meet the accuracy necessary for the t/c and comply with specifications. alibration program established for key quantities or values of the equipment where these properties have a significant effect on results. Equipment shall be calibrated or checked to establish that it meets the specification requirements and complies with relevant standards before being put into service. Equipment operated by authorized personnel. Up-to-date instruction on the use and maintenance readily available to operating personnel. QAM sec 9 AP no. 14 ompliance N N/A omments on ompliance ompliant as reviewed QAM sec Equipment list checked ompliant as reviewed QAM sec 9.3 ompliant as reviewed QAM sec 9.3 ompliant as reviewed QAM sec ompliant as reviewed Equipment and software uniquely identified. QAM sec ompliant as reviewed Records shall be maintained for each item of equipment, and shall include: a) Identity of item. QAM sec 9.2 ompliant as reviewed b) c) Manufacturer s name, type identification and serial number or other unique identification. hecks that equipment complies with the specification. QAM sec 9.2 ompliant as reviewed QAM sec 9.2 ompliant as reviewed Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 26 of 40

27 ISO/IE - Assessment hecklist ompliance N N/A omments on ompliance d) urrent location, where appropriate. AP No. 13 pg 4 ompliant as reviewed e) f) g) h) Mfr. s instructions, if available, or reference to their location. Dates, results and copies of reports and certificates of calibration, adjustments, acceptance criteria, and due date of next calibration. Maintenance plan, where appropriate, and maintenance carried out to date. Damage, malfunction, modification or repair to Equipment. Procedures for safe handling, transport, storage, use and planned maintenance of equipment. QAM sec ompliant as reviewed QAM sec 9.2 ompliant as reviewed QAM sec 9.2 ompliant as reviewed QAM sec 9.2 ompliant as reviewed QAM sec 10.1 AP No. 13, 14 Standards, measuring and test equipment significantly affecting the integrity of the measurements conducted by TSE are monitored for stability as part of the measurement control program pprocedures for safe handling, transport, storage and use of reference standards, materials and equipment (see Appendix H, AP No. 13and AP No. 14) Overloaded or mishandled equipment that gives suspect results taken out of service until repaired and calibrated. QAM sec d AP No. 13 pg 2 ompliant as reviewed Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 27 of 40

28 ISO/IE - Assessment hecklist Examine the effect of the defect or departure on previous t/c and initiate ontrol of nonconforming work procedures. Equipment shall be labeled, coded or otherwise identified to indicate status of calibration, including date calibrated, and date or expiration criteria when calibration is due. If equipment goes outside the control of the lab, it shall be proven that the function and calibration status are satisfactory before being returned to service. When it is necessary for intermediate checks a procedure shall be present. Procedure to ensure that correction factors are updated correctly. QAM sec AP No. 18 QAM sec AP No. 14 ompliance N N/A omments on ompliance ompliant as reviewed ompliant as reviewed QAM sec ompliant as reviewed AP No. 14 pg 13 ompliant as reviewed QAM sec AP No. 14 ompliant as reviewed Equipment and software shall be safeguarded from adjustments that would invalidate the t/c results. QAM sec AP No. 8 ompliant as reviewed 5.6 Measurement Traceability General Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 28 of 40

29 ISO/IE - Assessment hecklist Programs and procedures for the calibration of t/c equipment that has a significant effect on results. Equipment calibrated before being placed in service. QAM sec 10.0 QAM sec 10.1 ompliance N N/A omments on ompliance Measurements of TSE are traceable to the international system of measurements (SI) through an unbroken chain of measurements. Measurement traceability for TSE test are documented in traceability charts (see Appendix R and SOP 1006). calibrated and/or verified before use to ensure the recall or removal from service of any equipment or standards that are unreliable or that have exceeded the calibration interval Specific s alibration alibration laboratory s program for calibration shall ensure traceability to the International System of Units (SI). QAM sec 10.2 Appendix R SOP 1006 Measurements of TSE are traceable to the international system of measurements (SI) through an unbroken chain of measurements. Measurement traceability for TSE test are documented in traceability charts (see Appendix R and SOP 1006 SOP1006A) alibration certificates shall contain the measurement results, including the measurement uncertainty and/or a statement of compliance with an identified metrological specification. QAM sec 14.0 ompliant as reviewed Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 29 of 40

30 ISO/IE - Assessment hecklist ertain calibrations cannot be strictly made in SI units. In these cases, calibration shall provide confidence in measurements by establishing traceability to appropriate measurement standards such as: Use of certified reference materials provided by a competent supplier. Use of specified methods and/or consensus standards that are clearly described and agreed by all parties concerned. Participation in a suitable program of interlaboratory comparisons is required where possible. QAM sec AP No. 4 QAM sec AP No. 4 QAM sec ompliance N N/A omments on ompliance ompliant as reviewed ompliant as reviewed ompliant as reviewed PT Plan 4 year plan and Form 002 Up to date Use NAPT NAPT-PRESSURE /23/2015- En < 1 OK NAPT-OSOPE /30/ En < 1 OK NAPT-TORQSD /09/ En < 1 OK Testing Test labs requirements given in apply for measuring and test equipment, unless it has been established that the calibration contributes little to the overall uncertainty of the results. Where traceability to SI units is not possible or relevant, certified reference materials, agreed methods and/or consensus standards are required as for calibration labs (see ) Standards & Materials NA NA Not a test lab Not a test lab Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 30 of 40

31 ISO/IE - Assessment hecklist ompliance N N/A omments on ompliance Standards Programs and procedures for calibration of reference standards. standards shall be calibrated by a body that can provide traceability, as described in Standards used for calibration purposes only, unless shown that their performance as a standard is not invalidated. QAM sec 10.3 QAM sec AP No. 13 pg 2 ompliant as reviewed TSE uses accredited or approved laboratory with traceability to a national laboratory to calibrate working standards standards shall be calibrated before and after any adjustment. QAM sec AP No. 13 pg 7 ompliant as reviewed Materials Where possible, traceable to SI units, or to certified reference materials. Internal reference materials shall be checked as far as technically and economically possible. QAM sec AP No. 13 pg 8 QAM sec AP No. 13 pg 8 ompliant as reviewed ompliant as reviewed Intermediate hecks arried out according to defined procedures and schedules when needed. QAM sec & 6.0 AP No. 7 TSE performs intermediate checks of equipment calibration status See: SOI QA 1004, SOI QA 1005, SOI QA 1006, SOI QA 1007, SOI QA 1008, and SOI QA 1009 Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 31 of 40

32 ISO/IE - Assessment hecklist ompliance N N/A omments on ompliance Transportation and Storage Sampling Procedures for safe handling, transport, and use of reference standards and materials. Where necessary, a sampling plan and procedures. Where possible, based on statistical methods. Sampling plan and procedure are available where sampling takes place. lient-required deviations, additions or exclusion from the documented procedure shall be recorded in detail, with actual sampling data, and included in the documents containing the results. AP No. 13 pg 11 & 12 Procedure OK QAM sec 20 QAM sec 20 QAM sec Procedures for recording data. QAM sec Handling of Test and alibration Items NA No sampling Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 32 of 40

33 a) b) ISO/IE - Assessment hecklist Procedure for transporting, receipt, handling, protection, storage, retention and/or disposal of items. Items identified and identity retained throughout life of item in lab. Upon receipt of item, abnormalities or departures from normal or specified conditions are recorded. When suitability is in doubt, the client is notified. Procedures and facilities to avoid deterioration, loss or damage to t/c item. Assuring the Quality of Test and alibration Results Procedures for monitoring validity of t/c results; which may include: Regular use of certified reference materials and/or internal qc using secondary reference material. Participation in interlaboratory comparison or proficiency testing. QAM sec 12.0 ompliance N N/A omments on ompliance Items received for test are recorded in a laboratory work log and assigned a Service Order (SO) number that uniquely identifies the item during its stay in the laboratory. Service Orders are maintained in the laboratory. A Service Order is completed to include: the item received for test, name of company submitting the test items, and date of receipt. AP No. 5 Service Orders travel with items while at TSE AP No. 5 ompliant as reviewed AP No. 5 ompliant as reviewed QAM sec 11.0 AP No. 20 QAM sec 11.0 AP No. 20 TSE follows the procedures and checklist for measuring and testing instruments listed in the TSE Service guide. ompliant as reviewed c) Replicate t/c using same or different methods. QAM sec 11.5 ompliant as reviewed Legend: Your Document = Laboratory document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. = ompliant, N = Non-ompliant. Form 48B - Rev 3-04/04/14 Page 33 of 40