QUALITY ASSURANCE March 29, 2013 MANUAL Page 1 of 13

Transcription

1

2 MANUAL Page 1 of 13 Contents 0 Scope and Field of Application Organization Responsibilities Resources Management Representative... 3 Quality System General Quality Policy Quality System Procedures... 5 Document Control General Document Approval and Issue Document Changes... 6 Review of Requests, Tenders and Contracts Review Amendment to a Contract Records... 7 Subcontracting of Calibrations Purchasing Services and Supplies Service to the Client Complaints Control of Non-conforming Calibration Work Corrective Action Preventive Action Control of Records Internal Audits Management Review Quality Planning Training Environmental Conditions Calibration Process Control of Inspection, Measuring and Test Equipment Handling, Storage, Packaging, Preservation and Delivery Statistical Techniques... 13

3 MANUAL Page 2 of 13 0 Scope and Field of Application This document provides an overview of the Quality System in place at all Transcat facilities. It not only covers the calibration activities, but also other services provided by Transcat including validation, servicing of analytical equipment, inspection services and repairs. The instruments calibrated are used directly for making precision laboratory, workbench and process measurements for the calibration of process and production line mounted instruments and test sets. The activity of the Labs or directly in manufacturing and other processes mimics and/or verifies the final calibration activity of measuring and/or test instrument manufacturers. The fully operational condition of an instrument is the prerequisite to calibration. The calibration activity is in part dependent on an instrument repair activity to meet this prerequisite. The repair activity is not part of the scope of any registration/accreditation. However, because it may be performed on an instrument received for calibration service, portions of this transaction processing are covered by this document, and are identified as such. Transcat Calibration Labs have been audited for compliance and accreditation to ISO/IEC 17025:2005 and ANSI/NCSL Z The Certificates and Scopes of Accreditation for each individual lab are available on the Transcat web site, The calibration system and related activities comply with the requirements of ISO 9001:2008, ISO/IEC 17025, MIL STD 45662A, ANSI/NCSL Z540-1 and ISO 10012, as applicable. The reporting of defects and noncompliance per 10CFR21 is covered by documented procedures. The quality system meets the applicable requirements of 10CFR50 Appendix B and ASME NQA-1 Basic and supplements, as applicable. The policy on the confidentiality of all information is documented in P0105Ry. 1 Organization 1.1 Responsibilities The overall responsibility for quality rests with the CEO. Implementation of approved policies is the responsibility of his direct reports as well as the directors & managers of individual department and functions. The Technical Oversight Committee, overseen by the Director of Metrology and Quality Systems and comprised of technical and quality staff is responsible for recommendations to the senior staff regarding the technical direction of the Labs and for decisions on details of the processes employed. Specific position descriptions, responsibilities and minimum requirements for each position are detailed in the Position Descriptions maintained by the Human Resources Department. Access and control of these documents is covered by P0306Ry. Any manager has the authority to authorize departures from documented policies and procedures or from standard specifications, per policy P0107Ry. The manager must document the exception to the Quality Manager. The memo must detail who, what, where, when and why an exception was made. The Quality Manager will decide if further corrective/preventative action is required, and/or if additional Management Review is required.

4 MANUAL Page 3 of 13 If deemed necessary, the Director of Metrology and Quality Systems and Quality Manager have the authority to jointly request a halt to any work or practices felt to be inadequate or unsafe for either customers or employees, subject to further Management Review. 1.2 Resources Adequate resources and trained personnel to provide contract review and amendment, inspection of incoming customer equipment, monitoring of the calibration process and verification of final results, as well as handling, packaging and shipping are in place on a full-time basis. Internal audits of the Quality System and its procedural implementation at all sites are the responsibility of the Quality Manager. Internal technical audits to ensure technical competency and compliance with the technical requirements of the calibration program are the responsibility of the Director of Metrology and Quality Systems. No employee will be subjected to commercial, financial or other pressures that could adversely affect the quality of their work. It is the responsibility of every employee to perform their jobs in a manner that meets the customers' needs and those of the shareholders. This includes (but is not limited to) productivity, on-time delivery of service and profitability. No employee may accept any substantial personal gifts or gratuity from customers, vendors or other sources for services or other activities. Departments and labs are managed by responsible personnel in such a manner that their independence of judgment and integrity is maintained at all times. An Ethics Policy is in place, which includes alternative means of reporting issues outside the normal chain of reporting. 1.3 Management Representative The Quality Manager, reporting through the Director of Metrology and Quality Systems is the ISO/IEC Quality Manager. In this capacity, the Quality Manager has the responsibility and authority to ensure the day-to-day implementation of the Transcat Quality System. The Quality Manager works directly with the President/CEO and his direct reports as well as the directors & managers of individual department and functions to implement any Quality System modifications necessitated by changing market or operating conditions. Overall technical responsibility rests with the Director of Metrology and Quality Services, acting as the ISO/IEC Technical Manager. Both the Director of Metrology and Quality Services and Quality Manager have designated Deputies by appointment letter, to fulfill necessary functions in their absence. Jointly, the Director of Metrology and Quality Systems and Quality Manager are responsible for compliance to any and all applicable accrediting body requirements such as NVLAP Handbook 150.

5 MANUAL Page 4 of 13 TRANSCAT ORGANIZATION CHART

6 MANUAL Page 5 of 13 2 Quality System 2.1 General This manual is intended to provide the framework and outline of the Transcat Quality System. It is organized following the subsections of Section 4, "Management Requirements" of ISO/IEC Elements of Section 5 of ISO/IEC and other standards are integrated into appropriate sections as applicable. 2.2 Quality Policy Quality and continuous improvement are the basic operating principles for Transcat. Quality is knowing and understanding the requirements of our customers and suppliers and consistently meeting or exceeding those requirements, and is the responsibility of every Transcat employee. (The Quality Policy is posted in each Transcat office. The Quality Manager is responsible for providing all Transcat offices with current and updated versions of the Quality Policy.) Transcat, a supplier of a large variety of test and calibration equipment, additionally serves its customers with accredited calibration services, validation services, servicing of analytical equipment, inspection services and repairs. It is our intention to continue to merit our customers full confidence by providing both equipment and calibration services using state-ofthe-art equipment, good professional practices, documented procedures and trained personnel, all arrayed to provide prompt service of uncompromised competency and quality to the end product. The activities ensuring this level of service, including the maintenance of acceptable levels of measurement uncertainties for calibrations, are the responsibility of the CEO, acting through the staff and employees. Managers at all levels ensure the implementation and support of these goals through their own actions and the education of their assigned personnel. Each employee is expected to perform their job functions in furtherance of these goals. To facilitate this process within the company and to ensure continued compliance with the applicable International Standards, ISO9000 and ISO/IEC 17025, Transcat Policies and Procedures are implemented and are used in conjunction with, and in support of the activities documented in the Transcat Quality Assurance Manual. Policies are used as the method for distributing rules and guidelines for the Company. Procedures are the written step-by-step instructions for fulfilling the various functions. SOP s are used to link related functions into single overview documents showing process flow or various policies/procedures addressing requirements of the Standards. 2.3 Quality System Procedures All underlying documentation to the Quality System is implemented and maintained following the information detailed in Section 3 below. The effective implementation of the Quality System is ensured by training of personnel, internal audits - both formal and informal, and customer feedback, as well as audits and continuous assessments by qualified external agencies. It is the responsibility of the Quality Manager to ensure the continuity and maintain the overall integrity of the Quality System throughout all facilities and departments of the company.

7 MANUAL Page 6 of 13 3 Document Control 3.1 General Note: Document series are referenced by an alpha prefix unique to the series, "X"'s representing the individual document numbers, followed by an "R" for revision and a "y" for the current revision number. When a specific document is referenced, the "XXXX" is replaced by that document's unique identifier. The Transcat Quality System documentation includes the following: a. Quality Assurance Manual (QAMRy) b. Standard Operating Procedures (SOP s) (SOP-XXRy) c. Policies/Procedures (PXXXXRy) d. Training Courses/Qualification Exams (TXXXXXRy/EXXXXXRy) e. Position Descriptions (see P0306Ry) f. Qualification Documents (T1XXXXXXRy/T2XXXXXRy) g. Calibration Procedures (Data Sheets) (ACXXXXX-y)* h. Calibration Methodology Documents CP-XXXXXX/PCXXX i. Technical Policies/Procedures (CXXXXRy) j. Forms (FXXXXRy) Responsibility for the issuance, control and maintenance of all Quality System documents resides with the Quality Manager, with the exception of Calibration Procedures (Data Sheets), which are the responsibility of Lab Operations, and Position Descriptions, which come under the jurisdiction of the Human Resources Department. * Standard Data Sheets were still in use up to 2010 and will be in the format XXXXX-y. 3.2 Document Approval and Issue All documents reside in a secured corporate intranet directory. Procedure P0301Ry details generation of new procedures and maintenance of documentation. This procedure also includes the review and approval process for new documents. 3.3 Document Changes Document change procedures are also covered by procedure P0301Ry. This includes review of changes by affected parties, and maintenance of change information by the Quality Manager. A Master Index is maintained as part of the QA Sharepoint site and shows the current revision and date of each document. The version history is also maintained within the QA Sharepoint site and includes brief descriptions of any changes.

8 MANUAL Page 7 of 13 4 Review of Requests, Tenders and Contracts 4.1 Review Contract review is the responsibility of sales representatives. SOP-04Ry defines the steps required and calls out the supporting policies and procedures for the contract review process. P0401Ry covers calibration of new equipment, and P0402Ry covers calibration of customerowned equipment. Each procedure includes the necessary information to ensure that Transcat has the capability and capacity for fulfilling the contract prior to acceptance of the contract. Supporting documents include contract definitions and definition of services offered, as well as exception and non-conformance handling procedures. A web-based pricing and capabilities module is available to all sales representatives for pricing and direction of customer equipment to appropriate facilities. 4.2 Amendment to a Contract The procedure for amending a contract, whether the amendment is requested by the customer, or required by Transcat, is documented in P0409Ry. 4.3 Records Record maintenance for contract review and amendment records is covered by P0202Ry. 5 Subcontracting of Calibrations Calibration services performed on customer equipment by outside sources are not covered in the scope of the ISO/IEC accreditations. Transcat does have a program for evaluating and, if necessary, auditing the calibration vendors required for nuclear work, and maintains an approved vendor list for those vendors. The criteria for approved vendors are detailed in P0904Ry. The procedures for sending customer equipment out and receiving it back are detailed in P0901Ry and P0902Ry. Items are sent to outside sources for calibration only when Transcat does not have the technical capability to perform the calibration to the level required by the customer. The transaction is approved by the customer before the equipment is sent to a vendor. Upon return, a verification is performed as documented in P0902Ry. Work sent out for repair only is verified upon return by the calibration performed by Transcat. If, by contract, it is required that Transcat or our customer witness work performed at a subcontractor s facility, that requirement will be added to the purchase order and the Lab Manager or designee will make the appropriate arrangements. 6 Purchasing Services and Supplies Purchasing of calibration and repair services from qualified vendors for Transcat standards, as well as qualification of those vendors, is detailed in P0904Ry. Purchase of supplies related to the work performed, as well as shipping and packaging material is covered in P0908Ry. This procedure also addresses the incoming verification process for supplies. Incoming inspection and verification requirements for Transcat standards are detailed in P0604Ry.

9 MANUAL Page 8 of 13 7 Service to the Client Transcat is always willing to have customers visit any of its Labs for formal or informal audits, to witness their calibrations, or for any other assistance or information that may be required. Confidentiality is always maintained, per the Confidentiality Policy, P0105Ry. Any changes in status or delays in delivery are addressed through contract amendment per P0409Ry. Customer feedback is always welcome, and when a formal response is required, it is entered into the Corrective Action System (SOP-05). Transcat periodically conducts surveys of various segments of the customer base. The results of these surveys are tabulated and reviewed by senior management, either in a formal Management Review Meeting, or in a separate forum specifically addressing the survey results. Corrective or preventive action(s) to be taken based on this information is also tracked in the Corrective Action System. 8 Complaints All employees are encouraged to document feedback received from customers. Informal customer complaints are entered into the Complaint System per P0505Ry. Formal corrective action requests received from customers are addressed under the Corrective Action System per P0502Ry. 9 Control of Non-conforming Calibration Work When a Transcat standard or process is found to be out-of-tolerance, a Notice of Deviation is completed by the Lab, detailing the extent of the out-of-tolerance, and any possible impact on calibrations (customer and/or internal) performed since the last verifiable in-tolerance condition. Any customers, whose instruments may have been affected, are notified by the Lab and advised as to the extent of the potential problem. This process is documented in P0503Ry. Disposition of customer-owned equipment that cannot be brought into calibration is detailed in C0002Ry. New Transcat stock that is out-of-tolerance is returned to a designated location in the warehouse for return to the manufacturer for repair and re-calibration, and returned to inventory upon its return from vendor. 10 Corrective Action Corrective action requests are generated by customer and internal feedback, and by internal and third party audits. Procedure P0502Ry details Transcat s Corrective Action Request (CAR) System for the overall Quality System, while P0503Ry contains the corrective action process initiated when an issue involving the integrity of Lab processes is involved, such as out-oftolerance standards or environmental issues. Serious and critical Corrective Actions are reported to senior management, including the CEO and Vice-President, Lab Operations by the Quality Manager or Director of Metrology and Quality Services as soon as they are noted.

10 MANUAL Page 9 of 13 In general, the Quality Manager is responsible for ensuring that the appropriate level of corrective action is taken to prevent reoccurrence of any noted deviations in the entire system. Verification of effectiveness is performed under the direction of the Quality Manager by Internal Auditors, or in special cases, by other qualified individuals under the supervision of an Internal Auditor. 11 Preventive Action As with corrective action, preventive action requirements are generally initiated through feedback, Management Review or an audit. Preventive actions are also documented through the Corrective Action Request (CAR) System. Verification of effectiveness is an integral part of the CAR System process. The CAR System Procedure (P0502Ry) also details the management reporting responsibilities for both corrective and preventive actions. 12 Control of Records Quality record retention and disposal requirements are detailed in policy P0202Ry, except internal audit records, which are detailed in P0103Ry. In general, electronic records relating to the calibration data are maintained for ten years. Transactional records are maintained as required by legal and/or contractual requirements. Where possible, records are maintained on computer, with appropriate backup procedures in place. Older paper copies may be warehoused off-site in a secure facility. Current records are readily retrievable at each site, or at the corporate offices, depending on the nature of the records. Older records may require notice to retrieve from an off-site facility. The policy on records, P0202Ry, also includes requirements for legibility as well as instructions on corrections to records. 13 Internal Audits Internal audits are the responsibility of the Directors of Metrology and Quality Systems and the Quality Manager. They are scheduled based on a minimum of one audit per year for each site or department, or as indicated by open corrective action, or based on prior audit results. They may be scheduled or unannounced. As a minimum, all sections of the QA Manual relevant to the site, and the measurement parameters covered by the site s Scope of Accreditation are covered at least once a year. All open Corrective Actions are reviewed at each audit. P0103Ry includes details on the audits and their reporting. Items requiring corrective action are tracked via the CAR System and verified for effective implementation, as appropriate, per the CAR Procedure (P0502Ry). 14 Management Review Management Review occurs on a regular basis, per P0102Ry, which addresses frequency, attendees and topics to be covered. Any action items generated by these meetings is documented in the form of a Corrective Action

11 MANUAL Page 10 of 13 Request (CAR) and logged into that system for planning, implementation and verification of effective action. The Quality Manager is responsible for documentation and record maintenance from these meetings, as well as verification of any action to be taken Quality Planning Quality planning is an integral part of the Management Review process. As such, a specific area or areas are targeted for process improvement. Input is solicited from appropriate departments and personnel. Formal objectives are established for key individuals, and are tracked through the Management Review process. 15 Training It is the goal of Transcat to provide and encourage as broad a base of technical skills and customer knowledge as possible. In keeping with this, a wide range of in-house training is offered, and employees are also assisted with outside training courses to enhance their overall customer service and/or technical abilities. Position Descriptions for each job classification are the responsibility of the Human Resources Department. The control, issuance, review and change authority are detailed in P0306Ry. Employee training and qualification records are maintained, as detailed in P0202Ry. Specific technical training courses have been developed to provide initial training to personnel. This training may be required if the personnel are unfamiliar with a specific process or instrument type. Qualification and re-qualification of personnel are performed as necessary to maintain stated proficiencies. Testing is frequently required to verify the effectiveness of the training. 16 Environmental Conditions Environmental conditions and housekeeping requirements are detailed in P0613Ry. 17 Calibration Process The process carried out by the Transcat Calibration Laboratories is that of instrument calibration. The instruments calibrated belong to one of three categories: new instruments being purchased from Transcat, where a calibration is purchased with the instrument; customer-owned equipment being calibrated at the Transcat facility; and customer-owned equipment being calibrated at the customer's site. The calibration process itself is identical for all categories. However, some variations exist in the transaction processing. New instruments, never having been in service, do not require "as found" or "as received" data readings, which are of importance on instruments which have been in use by a customer. Additionally, no repair issues are involved with new stock calibrations, but may be required on customer equipment, and can cause changes to the initial contract if the need for repair was unknown to the customer prior to its return for calibration. Customer equipment received at the Transcat Lab requires incoming handling procedures to ensure proper tracking of that particular instrument throughout its processing. Calibrations performed at a customer's facility require additional precautions taken for the standards used in performing the calibration. Repair work cannot generally be done at a customer's site, and units found to be out-of-tolerance are usually returned to the lab for further

12 MANUAL Page 11 of 13 work prior to completion of the calibration. The agreed-upon service(s) to be performed are governed by the sales order generated as a result of the contract review with the customer by the Customer Sales and Service Group. The services available at the Labs are defined in policy P0410Ry. The actual calibration of the instrument is performed against the manufacturer's published specifications, unless otherwise specified by the customer, as documented during the contract review process (P0401Ry and P0402Ry). The calibration methodologies used are defined in the Calibration Policy, C0000Ry and subsidiary documents. The data readings to be taken for each model of instrument, and the acceptable results for that instrument, are detailed in the Calibration Procedure (Data Sheet) for the instrument, including any limitations to the performance of a full calibration. Special or limited calibrations are only performed with permission from the customer. The only case where a special process or non-standard methodology would be used is under specific request from a customer, negotiated through a detailed contract. This would be documented through the contract review procedure, and would include all agreed-upon criteria for the process, including test and verification of results. The calibration process actually consists of two components: the verification of readings for the unit under test, and the adjustment of the unit if it has out of tolerance readings (or, if requested by the customer, to optimize or zero the readings). Calibration procedures include such information as appropriate standard(s) to use, calibration test points, proper verification methodology, and expected results (as appropriate to the unit). The technician performs a preliminary inspection to ascertain that customer equipment is operable prior to starting the calibration. Calibration adjustments are made, as necessary, to outof-tolerance units after all as-received readings are completed. When a unit cannot be brought into tolerance by the recommended adjustments, a repair may be required and the customer is notified of the available course(s) of action, per P0409Ry. These include a repair of the equipment, or if beyond economical repair, the replacement or return of the equipment. Any subsequent action is based solely on the customer's request. Note: Although the repair activity is outside of the scope of accreditation, it is referred to here because it is part of the overall process. If a customer chooses this alternative, an additional calibration is performed following the repair, and a set of in-tolerance readings provides verification of the effectiveness of the repair process. Random verifications of completed calibrations are performed in accordance with P0601Ry. Wherever allowable by the equipment design, access to calibration adjustment circuitry is covered by a "CAL VOID" sticker. If a customer unit has a broken or damaged sticker, the technician will note the condition in Cert Comments in the order. Note: This may void any warranty or guarantee that is in force at the time. After the customer unit has been completed, if it is later found with a broken or damaged sticker prior to return to the customer, the calibration will be repeated. Where use of the sticker is not feasible, other precautions, such as sealing the adjustment pots, are taken where appropriate. The certificate and any associated documentation are reviewed by a qualified and appointed signatory, and the certificate is digitally signed by that person as evidence of the review. The Lab Manager s name is always printed on the certificate as the final responsibility for the adequacy of the calibration process within that facility. Note that the digital signature process has been validated for compliance to the applicable sections of 21CFR Part 11. Calibration cycles for customer units are based solely on the customer's determination. The

13 MANUAL Page 12 of 13 customer must determine their actual calibration cycle, based on their own history, and the criticality of the instrument within their own process. These are documented in the order as part of the initial contract review. When the customer cannot make a determination, the due date is left blank. The successful completion of a calibration is the first part of the final inspection process. The review of the documentation continues the process. The conclusion of the final inspection of the order is performed by personnel in accordance with P0712Ry. This inspection includes checking the unit against both the pick ticket, and the Certificate (and Data, if ordered). 18 Control of Inspection, Measuring and Test Equipment Transcat maintains and controls its inspection, measuring and test equipment (standards) using documented procedures. Standards shall not be used for calibrations if they are not within their valid calibration period. Records of the standards calibrations are maintained per P0202Ry. The standards and methods used in the calibration process are selected to target at least a 4:1 test uncertainty ratio (TUR) to the unit under test. (Where this is not possible for any reason, it is noted on the calibration certificate, and the actual TUR noted in the appropriate area on the Supplemental Data Sheet.) The laboratory is equipped with all items required to perform the required calibrations. When equipment (leased, borrowed, etc.) acquired from outside the laboratory s permanent control is put into service, it is treated as if it is a permanent standard with all applicable controls in place. These include, but are not limited to: a current calibration, verification of calibration results, physical examination, cross checks and maintenance, as applicable. Standards used in the calibrations are themselves calibrated on a regular basis, traceable to physical representations of the SI units through NIST, NRC or other National Metrological Institutes, or through ILAC-MRA accredited laboratories for the parameters being calibrated. The calibration cycle of each standard is determined by the manufacturer s recommendation, originally, and subsequently based on calibration history, periodic cross checks, frequency of use, and/or any failures or equipment stress. The guidelines for establishing/adjusting calibration intervals for Transcat standards are detailed in P0605Ry. When a Transcat standard or process is found to be outside of its established parameters, a Notice of Deviation is completed by the Lab, detailing the extent of the condition, and any possible impact on calibrations (customer and/or internal) performed since the last verifiable incontrol condition. Any customers whose equipment may have been impacted are notified by the Lab and advised as to the extent of the potential problem. This process is documented in P0503Ry. All Transcat standards have both their asset number and their most recent calibration sticker affixed to them (size permitting). Test equipment used for function check only is indicated by a tag stating such. Failed or out of tolerance equipment is prominently labeled with a Failed Equipment Tag to indicate rejection, and is generally removed from the work area Records for Transcat standards are maintained by each Lab. The records include calibration certificates and data, as well as maintenance records and any other pertinent historical information for the standard. In addition, the current information regarding last calibration and next calibration due dates is maintained within CalTrak. Records are labeled by the asset number and are maintained per P0202Ry.

14 MANUAL Page 13 of 13 As part of their training, technicians are instructed in the proper use, maintenance, handling and storage of Transcat standards. Preservation of the standards to assure continuous process capability is through periodic preventive maintenance, as recommended by the manufacturer and Transcat's experience with the assets. Specific preventive maintenance details are included in P0606Ry. Wherever allowable by the equipment design access to calibration adjustment circuitry is covered by a "CAL VOID" sticker. A broken or damaged sticker indicates the possibility of tampering, and voids the calibration. Software developed by Transcat for performing automated calibrations, adjustments or evaluation/calculation of calibration results is validated per P0304Ry. Commercial, off-the-shelf and/or OEM software is considered to be validated, however verification to a reasonable level is performed where technically feasible. The CalTrak software has been validated in accordance with 21CFR Part , with further additional validation of the electronic signatures to 21CFR Part 11. Records of the original validation, as well as validation of subsequent revisions are maintained in Rochester, and can be made available for review upon request. 19 Handling, Storage, Packaging, Preservation and Delivery Proper handling, packaging and storage of customer equipment is detailed in procedure P0706Ry. Each unit is tagged prior to entry into the Transcat system with a unique identifying number. Tagging instructions are included in P0701Ry. This identifier stays with the unit throughout its processing, and is recorded on all associated paperwork, as well as the unit's calibration label (size permitting). Procedure P0701Ry also covers tracking of customer equipment during transfers between Transcat facilities. All employees who may have occasion to handle customer equipment are instructed in its proper handling, including ESD procedures. Completed calibrations ready for shipment are staged in a designated area suitable for its protection while paperwork is processed. Delivery is by the carrier designated by the customer during contract review. Transcat also offers limited pickup and delivery service. The customer equipment is wrapped, packed and/or placed in tote bins and secured from movement during this process. 20 Statistical Techniques Feedback and complaints are monitored on a routine basis for repetitive problems, as well as for the effectiveness of applicable corrective action(s). Random sampling of individual calibrations is per P0601Ry, under the direction of the Director of Metrology and Quality Manager Systems. Uncertainty determination is performed per C0000Ry.