FLW FLW RECORD CONTROL APPROVAL SIGNATURES. Paul Peek, President, Service Manager, and Quality Manager

Transcription

1 FLW RECORD CONTROL APPROVAL SIGNATURES Prepared by: Date: Matthew Peek, Assistant to the Quality Manager Approved: Date: Paul Peek, President, Service Manager, and Quality Manager Calibration System Page 1 of 118 QA Manager:

2 Document Change Record Revision Section DCF ID Number Description of Change 1.0 ALL N/A New Document 2.0 ALL Complete revision to incorporate Z540-1 into the system. Changed document number from FQD 170 to FPD 370 because it is specific to calibration Measurement and Test Equipment. Added revised footer. Added Form P ; Removed reference to customer owned material. Added on calibration adjustment , 55 Added procedure to determine the correct calibration procedure. Clarified document revision status ,5.2,7.2,9.51 0,13, Changes to bring system into compliance with MIL-STD A , 79,80, 81,85,86, 87, 89, 90,91 Added position of Administrative Supervisor ( changes forms P , 4.3 & 2.3), added forms P370-22, 24, 28, 23, 25, 26, 28, see DCF changes for accuracy, clarification, efficiency Clarify calibration intervals / /00132 Responsibility for Form P / passwords in 10.7,e ; ,.4,.5,.6,.7; 13.8; 18.4; Forms P370-12, 39, 40 & , 141, 142, 143, 144, 146, 147, 148, 149 Verifying information; maintaining calibration documents for field use; defining computer data security; Form P370-38; extensions on M&TE; responsibility for monitoring Lab environment; responsibility for signing certificates , 0176 Added new form P370-46, modified form P370-2 to include Quality Manager , 0181 Added new forms P370-47, 48, 49, 50, 51, 52, & 53. Revised form P to TABLE OF CONTENTS Calibration System Page 2 of 118 QA Manager:

3 page 1.0 Purpose References Responsibility And Definitions Organization & Management Quality System, Audit and Review les...iles... Personnel Accommodation and Environment Equipment and Reference Materials Measurement Traceability and Calibration Calibration Methods Handling of Calibration Items Records Certificates and Reports Sub-Contracting of Calibration Outside Support Services and Supplies That Affect Calibration Results Complaints General Requirements for Quality Assurance of M&TE Detailed Requirements for Quality Assurance for M&TE FORM P Audit Check List FORM P Job Descriptions FORM P Laboratory Capability Documentation Guideline FORM P Signatories FORM P Service Organization Chart FORM P Service Label Identification. 79 FORM P Calibration Data Report. 82 FORM P Type K Thermocouple Calibration Report. 84 FORM P FLW Service Payroll. 85 FORM P Calibration Certificate 86 FORM P Calibration Extension Request.. 87 FORM P Temperature Uniformity Survey. 88 FORM P Manual Revision Verification.. 91 FORM P Certificate of Calibration.. 92 Calibration System Page 3 of 118 QA Manager:

4 FORM P ESD Wrist Strap Check Log Sheet.. 93 FORM P MIL-STD-45662A Checklist. 94 FORM P Certificate of Calibration. 99 FORM P ESD Mat Ground Verification Log. 100 FORM P Master Manual Index FORM P Master Manual Index Log FORM P Technician Work Sheet 103 FORM P Parts Order Form. 104 FORM P Certificate of Calibration - Flow Meter 105 FORM P Calibration Certificate - Force. 106 FORM P Calibration Certificate - Force Verification of Testing Machines 107 FORM P Lab Shutdown Log FORM P Data Report FORM P Type K Thermocouple Calibration Report Worksheet 110 FORM P Data Report FORM P Field Document Index FORM P FLW Service Department Warranty form 113 FORM P Field Manual Log. 114 F FORM P Certificate Attachment. 115 FORM P Certificate of Compliance 116 FORM P Notification of an Out of Tolerance Condition 117 FORM P Out of Tolerance Standard Evaluation. 118 FORM P Data Report FORM P Data Report FORM P Data Report FORM P Data Report FORM P Data Report FORM P Data Report FORM P Data Report Calibration System Page 4 of 118 QA Manager:

5 1.0 PURPOSE This document defines or identifies the policies, procedures and requirements of the FLW Calibration System. It s purpose is to assist in formulating and providing for the uniform evaluation of the Laboratory s compliance to the individual requirements of ISO 9001:2000 (E), ISO/IEC 17025:2005(E), and ANSI/NCSL Z540-1:1994. This document follows the format employed by ANSI/NCSL Z Part 1 of the document deals with the general requirements in accordance with which a calibration laboratory must demonstrate that it operates, if it is to be recognized as competent to carry out specific calibrations; and in the development and implementation of the FLW quality system. Part II deals with the quality assurance requirements for this Supplier s system to control the accuracy of the measuring and test equipment (M&TE) used to assure that the supplies and services provided comply with prescribed requirements. The FLW Calibration System is designed to meet the following standards: ISO 9001:2000(E) ISO/IEC 17025:2005(E) ISO :1992(E) ANSI/NCSL Z MIL-STD-45662A:1988 This facility may also comply with additional Standards, Regulations, or Accreditation requirements. 2.0 REFERENCES 2.1 International Standard ISO 9002:1994(E) 2.2 International Standard ISO :1992(E) 2.3 ISO/IEC 17025:2005(E) 2.4 ISO 8402:1988 Quality Vocabulary 2.5 ANSI/NCSL Z540-1: MIL-STD-45662A: FLW QA100 - Quality Assurance Manual 3.0 RESPONSIBILITY AND DEFINITIONS 3.1 Responsibility The QA Manager is responsible for maintaining the FLW Calibration System. The Service Manager is responsible for implementing the policies in this document and training on the policies and procedures contained herein. This document will be reviewed annually or as needed for essential changes. 3.2 Definitions calibration: The set of operations that establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, and the corresponding standard or known values derived from the standard. certificate of calibration: A document that presents calibration results and other information relevant to a calibration. Data consisting of pass or fail is sufficient for most calibrations unless numeric information is requested by the customer. calibration method: Defined technical procedure for performing a calibration or verification. certified reference material (CRM): A reference material one or more of whose property values are certified by a technically valid procedure, accompanied by or traceable to a certificate or other documentation which is issued by a certifying body. Calibration System Page 5 of 118 QA Manager:

6 interlaboratory comparisons: Organization, performance and evaluation of calibrations on the same or similar items by two or more laboratories in accordance with predetermined conditions. international ( measurement ) standard: A standard recognized by an international agreement to serve internationally as the basis for fixing the value of all other standards of the quantity concerned. influence quantity: A quantity which is not the subject of the measurement but which influences the value of the measurand or the indication of the measuring instrument. Examples: ambient temperature; frequency of an alternating measured voltage. Laboratory / calibration laboratory: A body that calibrates or performs calibrations and verifications. In cases where an organization carries out other activities besides calibration, the term laboratory refers only to those parts of that organization that are involved in the calibration process. limits of permissible error ( of a measuring instrument ) The extreme values of an error permitted by specifications, regulations, etc. for a given measuring instrument. (Also called tolerance ). measurand: A quantity subjected to measurement, e.g., the Volt. Also called the measured quantity or the quantity to be measured. measurement: The set of operations having the objective of determining the value of a measurand. measurement standard: A material measure, measuring instrument, reference material or system intended to define, realize, conserve or reproduce a unit or one or more known values of a quantity to serve as a reference. measuring and test equipment: ( M & TE ) All of the measuring instruments, measurement standards, reference materials, and auxiliary apparatus that are necessary to perform a measurement. This term includes measuring equipment used in the course of testing and inspection, as well as that used in calibration. measuring instrument: A device intended to make a measurement, alone or in conjunction with supplementary equipment. mutual consent standard: An artifact or process that is used as a de facto standard by mutual consent of the supplier and customer when no recognized U.S. national standard is available. national (measurement) standard: A standard recognized by an official national decision to serve, in a country, as the basis for fixing the value of all other standards of the quantity concerned. proficiency testing: Determination of the laboratory calibration performance by interlaboratory comparisons or other means. (quality) audit: A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. quality manual: A document stating the quality policy, quality system and quality practices of an organization. quality system: The organizational structure, responsibilities, procedures, processes and resources for implementing quality management. (quality system) review: A formal evaluation by management of the status and adequacy of the quality system in relation to quality policy and new objectives resulting from changing circumstances. reference material: A material or substance of which one or more properties are sufficiently well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to Calibration System Page 6 of 118 QA Manager:

7 materials. reference standard: A standard, generally of the highest metrological quality available at a given location, from which measurements made at that location are derived. requirement: A translation of the needs into a set of individual quantified or descriptive specifications for the characteristics of an entity in order to enable its realization and examination. traceability: The property of a result of a measurement whereby it can be related to appropriate standards, generally national or international standards, through an unbroken chain of comparisons. uncertainty of measurement: Parameter, associated with the result of a measurement, that characterizes the dispersion of the values that could reasonably be attributed to the measurand. verification: (Also calibration ) Evidence by calibration that specified requirements have been met. PART I 4.0 ORGANIZATION & MANAGEMENT 4.1 Organization 4.2 Management a) FLW maintains an organization, designated as FLW Service Company, a California corporation solely owned by FLW, Inc., which provides technical support, service, repair facilities and calibration services to FLW customers. FLW Service is responsible for establishing and maintaining traceability of the Electrical, Physical, Mechanical and other Standards and M & TE for which traceability to National Standards is required. b) The FLW laboratory will maintain an environment of a Type II Laboratory, as specified in Section 7 of this document. Monitoring of the environment of the lab will be the responsibility of the Technical Manager, but will be supported by the Service Manager or Senior Lab Technician in the absence of the Technical Manager. The Technical Manager, Service Manager or Senior Lab Technician will cease all calibration activities in the lab when the environment is outside the defined limits. The Technical Manager, Service Manager or Senior Lab Technician will reinstate the calibration process in the lab, only when the environment stabilizes for a period of at least two hours, to within those conditions specified in Section 7. This event will be recorded on Form P for which the Service Manager is the responsible authority. There will be no unusual environmental control in the lab outside those requirements set forth in Section 7. If a special requirement in environmental control is required to fulfill those requirements needed for calibration, the Technical Manager will inform the Service Manager of this need, and the Service Manager will seek an appropriate qualified 3 rd party source to provide the calibration. c) The term laboratory refers only to those parts on FLW that are involved in the calibration process. Access to the Laboratory and Laboratory storage areas is restricted to Laboratory personnel or those specifically authorized by the Service Manager. a) The activities of the Laboratory are directed by the Service Manager who reports directly to the President. Activities are monitored by the Quality Assurance Manager who reports directly to the President. The Technical Manager, who reports to the Service Manager, has overall responsibility for the technical operations. Alternates will be designated in case of absence of the Service Manager, Technical Manager or the Quality Manager. b) Laboratory management has been given the authority and resources needed to discharge their duties. Laboratory personnel are free from undue pressures which might adversely affect the quality of their Calibration System Page 7 of 118 QA Manager:

8 work by having all communications (priority requests, complaints, status inquiries, etc.) directed through supervision and/or administrative personnel. c) The Laboratory is expected to operate so that quantity does not influence quality. Employee performance goals are based primarily on the quality of work. Confidence in the Laboratory s independence of judgment and integrity is maintained at all times. d) If requested by a customer in order to protect confidential information and proprietary rights, all data pertaining to work accomplished together with any documents received from the customer will be maintained in a key-locked file. Data transmitted from FLW to the customer will be made according to specific directions from the customer in order to preserve his confidentially. e) Responsibility, authority and interrelation of all personnel who manage, perform or verify work affecting the quality of calibrations are documented in FORM P Organization Chart and FORM P Job Descriptions. f) Laboratory supervisors will have the necessary training and skills in related disciplines sufficient to understand the measurements being made, assess the result, and make decisions that affect the quality of the results. g) A Technical Manager will be designated whose job description includes the power to make decisions regarding the technical (standard selection, calibration method selection, technical qualification of personnel, etc.) aspects of laboratory operations. The Technical Manager may be assigned other laboratory responsibilities. h) The responsibility for the quality system of the laboratory is assigned to the Quality Manager who must be free of pressures which represent a conflict to the quality of calibrations. The Quality Manager reports directly to the President. He also has direct access to the Technical Manager. i) Individuals who have the required knowledge and expertise to assume the duties of the technical or quality manager will be assigned as alternates to provide continuity of operation during absences of the Technical Manager &/or Quality Manager. j) When possible, the Laboratory will participate in measurement assurance programs (MAPS) or other types of inter-comparison programs between laboratories which provide increased confidence in processes and procedures. The appropriateness of such programs may be determined by the laboratory and/or customer needs. 5.0 QUALITY SYSTEM, AUDIT AND REVIEW 5.1 FLW s quality system with policies and practices is documented in Quality Manual QA-100. This manual defines the policies and practices which must be followed in the conduct of the Laboratory s business. This manual defines FLW s objective for, and its commitment to, good laboratory practice and quality of calibration services. Laboratory management is responsible for ensuring that all Laboratory personnel are aware of, understand, and implement the elements of the quality system. The Quality Manager is responsible for maintaining the Quality Manual. 5.2 Policies and operational procedures established in order to meet the requirements of the referenced standards are contained in the FLW Quality Manual - QA-100. A copy of this manual is available at several locations within FLW and is available to all employees at all times. Employees are encouraged to seek interpretation or clarification of the contents of this manual at any time. Training classes are held such that all Laboratory employees are familiar with the general contents of the manual, especially those contents having the objective of promoting good laboratory practice and quality calibration services. Calibration System Page 8 of 118 QA Manager:

9 5.2 (a) FLW QA 100 Quality Manual contain statements of quality policy including objectives and commitments by top management to provide sound and reliable services to FLW s customers. 5.2 (b) The organization and management structure of the Laboratory together with job description of key Laboratory management and operational positions are documented in FORM P and FORM P An overview of the company is shown on the organizational chart in QA-100. These charts establish the chain of command and identify responsibilities and personnel who have critical positions within the laboratory. 5.2 (c) The relation between management, technical operations, support services and the quality system is described in QA FLW Quality Assurance Manual, Management Responsibility. Also refer to 5.2 (b). 5.2 (d) Procedures for the control and maintenance of documentation in the FLW Quality Control system are found in FQD Document Control, FQD Data Control and FQD Record Control. 5.2 (e) Job descriptions of personnel in positions of responsibility as well as those in support categories in the laboratory and those who are empowered to make decisions are included in FPD 370 FORM P370-02, as are references to the job descriptions of other staff. 5.2 (f) Approved signatories competent to sign accredited laboratory test and calibration reports are defined in FPD FORM P Even though the concept of approved signatories is a concept of accredited laboratories, FLW wishes to be compliant with this standard. 5.2 (g) Methods and procedures used to establish the traceability path to; a national laboratory, an intrinsic standard or other acceptable source are described in section 9.2 and 9.3 of this document. 5.2 (h) The laboratory s scope of calibrations and/or verification is listed in FORM P Calibration Laboratory Capability Documentation Guideline. This document cites a basic measurement discipline (DC/Low Frequency) and then the various sub-parameters under that specific discipline (voltage, resistance, current, etc.) 5.2 (i) A review of all new work will be made to ensure that the laboratory has the personnel, facilities, equipment, standards, and technical expertise necessary to handle the proposed work effectively before it is accepted. Particular attention is paid to work of a type not currently being performed in the laboratory. Work that is of the same type as previously performed is automatically accepted. New work of a type not previously performed must be approved by the Service Manager or Technical Manager. 5.2 (j) All calibrations conducted by this laboratory are performed in accordance with approved calibration procedures. Development and/or selection of procedures is based on suitability for purpose and customer requirements. All procedures are developed or selected and approved for use in accordance with guidelines found in sections 8 & 9 of this document. These procedures are a controlled document and carry the designated approval signatures and issue date in accordance with FQD Document Control. 5.2 (k) Requirements for documentation, handling and verification of calibration and verification items, which primarily are customer equipment or devices under test are described in FQD Control of Non-Conforming Material, FQD Document Control, FQD Record Control, FQD Material Identification and Traceability, FQD Inspection and Test, FQD Test Status and FQD Warehouse Control. 5.2 (l) A general description of the measurement systems and measurement standards used by the laboratory are described in sections 8 and 9 of this document (m) Procedures for calibration, verification, and maintenance of all laboratory equipment owned, rented or leased having an affect on the results on the calibration services provided are described 8 and 9 of this document. 5.2 (n) Quality assurance practices are used to (1) determine agreement between laboratories, (2) demonstrate compliance to certain specifications, (3) indicate that the measurement processes are under statistical control (4) demonstrate traceability, and (5) ensure the quality of results. Details are found in Section 5.6 and Section 9 of this document. Calibration System Page 9 of 118 QA Manager:

10 5.2 (o) Procedures to be taken when it is discovered that an error has occurred or procedures were not followed are given in FQD Corrective Action Procedure. An assessment of the impact of the discrepancy on the results of measurements and a determination of appropriate corrective action shall be conducted. This requirement pertains to discrepancies or departures discovered after they have occurred. Corrective action report(s) must be filed and the discrepancy will come before management review. 5.2 (p) Laboratory management is responsible for ensuring that laboratory policies and procedures are adhered to. There will be no deviations from the guidelines in this document. If any portion of this document needs to be enhanced for better clarification, appropriate CARs and Document Change forms will be generated according to FQD 104 and FQD (q) Procedures for dealing with complaints are given in FQD Customer Complaints and section 16 of this document. 5.2 (r) The laboratory s procedures for identifying and protecting any customer information or material considered confidential or proprietary is discussed in 4.2 (d) 5.2 (s) An audit is a detailed evaluation of compliance with the quality system. It attempts to find out if the system is in fact working the way it is documented. A review is a comparison of the system with the general standard, other quality needs, and the general business of the laboratory to determine if something needs to be changed in the system which will end up with new or revised documentation. Requirements for audit and review procedures are defined in the referenced documents and in FQD Quality Audits, FPD Internal Audits and FPD Subcontractor/Supplier Audits and in 5.3 through 5.5 below. 5.2 (t) Section 9 of the Standard specifies the requirements for establishing calibration intervals. These procedures are stated in FPD 370 Section Intervals of Calibration and Verification. 5.2 (u) The method of calibration employed will be appropriate for the parameter being calibrated/verified. A detailed calibration procedure will be available and followed to the degree necessary for the calibration/verification being performed. The use of well documented calibration procedures is desired in order to maintain consistency of the measurement process when performed at different times and with different operators. The standards selected and their associated uncertainties or tolerances should be adequate for the calibration/verification being performed. (Reference: FPD 370 Sections 10 and 11) 5.3 A quality audit is a periodic check to ensure that the laboratory is operating in accordance with the policies and procedures set out in the Quality Manual and related documentation. Quality audits may include audits of results. Audit intervals are based on an analysis of factors such as risk, criticalness of the measurement system, complexity of the system, and failure rates, etc. and may be different for each measurement area. Audits are conducted by persons possessing the knowledge and skills necessary to understand the process being audited as well as the process of auditing and are reviewed by upper management Immediate corrective action must be taken to prevent taking bad data and /or the generation of inaccurate results. If possible, Auditors will be selected and trained under the provisions of ISO :1991(E) Qualification Criteria for Quality Systems Auditors. Audits will be performed using the criteria in ISO :1990(E) - Guidelines for Auditing Quality Systems. (Reference: FLW FQD Quality Audits; FLW FPD Internal Audits and FLW FPD 122 Subcontractor/Supplier Audits, and 5.6 below.) 5.4 A quality system review is an examination of the entire quality system conducted by management to ensure that it is adequate for the achievement of the laboratory s quality objectives on a continuous basis. Management may delegate the responsibility of scheduling the reviews to the Quality Manager or other appropriate individual but a complete review of the FLW Quality System must be accomplished at least once each Calendar year. Quality spot checks may also be performed on an irregular basis. These checks and reviews may include: a) Matters arising from the previous review; b) Reports from audits by clients (if applicable); Calibration System Page 10 of 118 QA Manager:

11 c) Results of internal audits and audit spot checks done since the last review, including corrective actions implemented; d) Details of any complaints from clients; e) Staff training (for both new and existing staff members); f) Adequacy of staff, equipment and facility resources; and g) Future plans and estimates for new work, new staff, new equipment, etc. 5.5 Documentation shall be maintained, in a form suitable for assessment, for all management reviews of the quality system and resulting corrective actions ( if any ). Corrective action is required whenever evidence arises that the quality system is not functioning properly. The person responsible for quality is designated by FLW s President and is normally the Quality Manager. (Reference: FQD Corrective Action Procedure and FPD 121- Internal Audits) 5.6 Internal quality control programs are an integral part of any calibration laboratory program. The extent and detail of the program may vary based on the size and complexity of the laboratory s range of calibrations. In addition to periodic audits the Laboratory shall ensure the quality of results provided to customers by implementing checks. FLW will consider implementing internal random sampling whereby random items of instruments whose calibrations are completed are re-calibrated either by separate FLW personnel or by an outside laboratory. These sampling schemes may be based on a percentage of instruments calibrated where the percentage may be increased or decreased based on the number of failed inspections if any. Other internal quality control methods may be considered as appropriate in the continuing effort to support the credibility of the Laboratory and support the validity of calibrations performed by the laboratory. Records on sampling need to be kept only where discrepancies are identified. 6.0 PERSONNEL 6.1 The Laboratory will maintain a staff of sufficient size and with the necessary education, training, technical knowledge & experience for their assigned functions, and to satisfy the capacity and technical capability needed to support its workload. The Laboratory workload capacity is enhanced by a continuing program of cross-training between the various technical disciplines; also training in competency in auditing. 6.2 One goal of the Laboratory is to have all technicians trained in all functions handled by the Laboratory. Onthe-job training using trained personnel and appropriate technical literature will be provided to new or experienced employees as circumstances permit to enhance their technical skills. Training of Laboratory personnel will be kept up to date consistent with employee assignments and development. 6.3 Current records of technical personnel and their relevant qualifications, skills, work experience, formal education, technical training, on the job training, technical license, certifications, and degrees is maintained and available to laboratory management and employees. (Reference: FLW employee training files ) 7.0 ACCOMMODATION AND ENVIRONMENT 7.1 Laboratory facilities, calibration areas, lighting, temperature, humidity and ventilation shall be such as to facilitate proper performance of calibrations &/or verifications. However, only the environmental factors which could affect the accuracy, stability, or performance of the calibration require control. Human factors such as lighting and ventilation should be sufficient to perform the required tasks. 7.2 The environment in which calibration and verification activities are undertaken in the Laboratory is specified Calibration System Page 11 of 118 QA Manager:

12 below. This environment will not invalidate the results or adversely affect the required uncertainty of measurements. Particular care will be taken when calibration and verification activities are undertaken at sites other than the permanent laboratory premises. FLW maintains a Type II Laboratory. Minimum Requirements for this Laboratory are: a) TEMPERATURE will be maintained at 70 ± 2ºF. b) HUMIDITY will be maintained between 25% and 60%. c) BAROMETRIC PRESSURE: will be monitored but not recorded or controlled. d) PRESSURE, LIGHTING, ACOUSTIC NOISE, VIBRATION: no specific requirements. e) SMOKING will not be permitted inside the entire building. f) FOOD will not be permitted inside the Type II calibration area. Temperature and humidity will be continuously monitored within the laboratory and records of this data will be retained. Attention shall be paid to dust, electromagnetic interference, line voltage, sound, vibration levels and any other environmental influence factors which affect the specific measurement being performed appropriate to the concerned calibrations. Since environmental conditions outside the laboratory cannot be controlled, humidity and temperature must be monitored, appropriate correction factors must be applied, where relevant, and identified on calibration reports. Particular concern will be given to electrostatic discharge effects to sensitive solid state devices. Procedures contained in FQD 102, Procedure for Handling ESD Devices, will be observed. 7.3 The Laboratory shall effectively monitor, control and record environmental conditions as appropriate. Due attention shall be paid, for example, to biological sterility, dust, electromagnetic interference, humidity, line voltage, temperature, and sound and vibration levels, as and if appropriate to the calibrations concerned. 7.4 Incompatible activities in the calibration process may require effective separation by effectively shielding or isolating by distance between neighboring test areas. 7.5 Access to and use of all areas affecting the quality of measurements shall be defined and controlled. Access is allowed only to qualified personnel as determined by the Service Manager. Also the quantity of personnel entering an environmentally controlled area should be limited as the more personnel entering the area, the more dust, dirt and possible temperature rise could be detrimental to the measurements. 7.6 Good housekeeping practices have a positive impact on the quality of the calibration/verification being performed. Therefore adequate measures shall be taken to ensure good housekeeping in the laboratory 8.0 EQUIPMENT AND REFERENCE MATERIALS 8.1 The laboratory shall be furnished with all items of equipment (including reference materials) required for the correct performance of calibrations/verifications. In those cases where the laboratory needs to use equipment outside its permanent control, it shall ensure that the relevant requirements of the standard are met. Borrowed or rented equipment will have on file objective evidence that the calibration was performed in a manner which meets the requirements of this standard. Examples of objective evidence may be: a) records of FLW audits b) proof that the calibration laboratory is accredited against this Standard. Calibration System Page 12 of 118 QA Manager:

13 c) acceptance by a government agency showing compliance to this Standard. d) acceptance conforming to this Standard from the calibration laboratory customer. 8.2 All equipment shall be properly maintained. Maintenance procedures shall be documented. Any item of the equipment which has been subjected to overloading or mishandling, or which gives suspect results, or has been shown by verification or otherwise to be defective, shall be taken out of service, clearly identified and wherever possible stored at a specified place until it has been repaired and shown by calibration or verification to perform satisfactorily. The laboratory shall examine the effect of this defect on previous calibrations. The following procedures are in effect: a) historical maintenance information is kept in a computer program for all FLW M&TE. b) any instrument that has been subjected to any influence that might cause doubt as to its integrity is removed from service, tagged as out of calibration and stored in the special location marked Nonconforming. c) computer records of M & TE allow all instruments that have been calibrated by the suspect unit to be identified. A determination will be made if notification to customers of a recall of previously calibrated equipment is justified. d) after correction of any default and recalibration, the unit may be tagged with a current valid calibration tag and returned to service. e) a review of the units Calibration Interval will be made and adjusted if required to preclude any future calibration errors. 8.3 Each item of equipment including reference materials shall, when appropriate, be labeled, marked or otherwise identified to indicate its calibration status with: a) A tag physically attached to the equipment or wired to the equipment as appropriate. b) If a tag can not be installed on the equipment a calibration tag will be fastened to its container or placed physically close to the equipment to show calibration status. c) Calibration status may also be determined by entering the serial number or FLW asset number in the M & TE computer program which lists the continuing history of the equipment s calibration status. d) No equipment may be used for calibration/verification without evidence of proper, current calibration 8.4 Records shall be maintained of each item of equipment and all reference materials significant to the calibration/ verifications performed. The records shall include at a minimum: a) The name of the item of equipment; b) The manufacturer s name, type identification, and serial number or other unique identification; c) Current location, where appropriate; d) Where applicable, dates and results of calibration and/or verifications and date or criteria when the calibration and/or verification expires; e) Details of maintenance carried out to date; Calibration System Page 13 of 118 QA Manager:

14 f) History of any damage, malfunction, modification or repair; g) Measured value observed for each parameter found to be out of tolerance during calibration/verifications 9.0 MEASUREMENT TRACEABILITY AND CALIBRATION 9.1 All measuring and testing equipment having an effect on the accuracy or validity of calibrations shall be calibrated and/or verified before being put into service. The laboratory has established this program for the calibration and verification of its measuring and test equipment to ensure the recall or removal from service of any standard or equipment which has exceeded its calibration interval or is otherwise judged to be unreliable. FLW computer calibration records identify: a) M & TE in calibration that is usable in the calibration/verification process. b) M & TE requiring calibration, i.e. a recall system that includes identification of overdue items in the recall system and removal of such items until corrected. c) M & TE that is broken, out of tolerance, unstable or intermittent in operation. (Reference: FQD Control of Non-Conforming Material; FQD Test Status) Any M & TE borrowed or rented for calibration/verification purposes will be treated as FLW M & TE while at FLW. Computer records are kept as if the equipment were FLW owned and maintained for a period equal to FLW M & TE. Thus the same history and recall mechanism is available with this equipment The recall system uses the M & TE data base which allows complete identification of the M & TE as well as a history of any calibration or operational problems. Equipment is tracked for timely recalibration cycles. Any equipment out of calibration cycle will be taken out of service until calibrated. Repeated problems such as out-oftolerance conditions of the same parameter of the same unit will be investigated. Equipment showing abnormal behavior will be temporarily removed from the active inventory until the problems have been clearly identified and can be controlled. Once any problems are understood and corrected the equipment can be entered into active inventory after adequate calibration. 9.2 The overall program of calibration and/or verification of equipment shall be designed and operated so as to ensure that, wherever applicable, measurements made by the laboratory are traceable to national, international, or intrinsic standards of measurement where available. Calibration certificates and/or reports shall, wherever applicable, state the traceability to national, international, or intrinsic standards of measurement and shall provide the measurement results and associated uncertainty of measurement and/or a statement of compliance with an identified metrological specification. It is not necessary to state further identifiers such as bookkeeping numbers, NIST report numbers, etc. 9.3 Where traceability to international, national, or intrinsic standards of measurement is not available, traceability requirements may be satisfied by: a) Participation in a suitable program of interlaboratory comparisons or proficiency testing; b) Internationally accepted standards in the field concerned; c) Suitable reference materials; d) Ratio or reciprocity-type measurements; or e) Mutual consent standards which are clearly specified and mutually agreed upon by all parties concerned. Calibration System Page 14 of 118 QA Manager:

15 9.4 Reference standards of measurement held by the laboratory shall be used for calibration or verification only and for no other purpose, unless it can be demonstrated that their performance as reference standards will not be invalidated. 9.5 Reference standards of measurement shall be calibrated by a competent body that can provide traceability as described in 9.2 or 9.3. FLW has established a program of calibration and verification for reference standards. (Reference: Part II of this document.) 9.6 Where relevant, reference standards and measuring and calibration equipment shall be subject to in-service checks between calibration and verifications. In some applications certain standards and equipment might require additional checks and verifications in addition to the normal calibrations performed based on the official recall system. Such checks help in providing trend and control charts, improve the maintenance of drift rates, and increase confidence in measurement capability. 9.7 Reference materials shall, where possible, be traceable to national or international standards of measurement, or the national or international standard reference materials CALIBRATION METHODS 10.1 The laboratory has documented instructions on the use and operation of all relevant equipment, on the handling and preparation of items, and for calibration/verification, where the absence of such instructions could jeopardize the calibration/verification. All instructions, standards, manuals, and reference data relevant to the work of the laboratory are maintained up-to-date and are readily available to the staff. Documented instructions do not necessarily mean hard copy documents. Documentation can be in the form of software, CD ROM, microfilm or other suitable medium. The detail and instructions necessary to accomplish a measurement vary according to the skill and experience of the metrology engineer or technician, the complexity of the calibration being performed and the frequency that the calibration is performed. A senior technician may not need to refer to the documentation as often as an entry level technician. Documentation can include: a) Calibration procedures or procedure checklists b) Equipment installation, operator and service manuals, c) Reference books, such as engineering tables, ISO International Vocabulary, technical textbooks and, d) Equipment manufacture s application notes Determining the Calibration Procedure to Utilize. Calibration procedures should meet the customers needs. If the customer has special calibration procedures required, they will take priority. If no special process is required then the manufacturers procedure will be utilized. If the manufacturer s calibration procedure cannot be obtained, then an acceptable published industry standard such as GUIDEP, IPTS, ASTM, ANSI, etc., may be utilized. Where no procedures can be found, a local procedure may be written with the Technical Manager s signature of approval Control of Calibration Procedures All procedures utilized in the laboratory by FLW service personnel will have a special FLW Procedure Number. This number will be identified as SXXXX and will be identified in whole numbers. Each procedure will have a unique number attached. Calibration System Page 15 of 118 QA Manager:

16 Procedures utilized in the field will be identified by the FLW SXXXX number or by the specific procedure as described in of this document All calibration procedures utilized in the laboratory will be listed in the Master Manual Index. Section 1 of the Master Manual Index identifies procedure location, manufacturer, model number & description, revision and revision date of procedure, last date reviewed by FLW personnel, special FLW procedure number, master or secondary. The master copy is utilized for calibration. The secondary copies are for reference only. The Master Manual Index will be reviewed and updated annually or sooner when required. A Master Manual Index Log (Form P370-21) will be utilized to keep track of the updates Each calibration document will have a front page entry listed as Manual Revision Verification. Ref. Form P This front page will identify the copy as either the Master or Secondary; Revision level of manual and Revision date; the latest revision level and date supplied by manufacturer, if different from the one being utilized; a statement stating if a later revision of the document will have procedures that will have a significant affect on the results; who verified the information and date. Signature for verification of Form P370-14, for those procedures that come from Manufactures, existing National standards, or existing special processes, may only be given by technicians who have signatory approval. All new procedures generated by FLW personnel and documented in the Master Manual Index must be signed by either the Technical Manager or the Service Manager Field Service technicians will each be given a Field Service Manual that will contain calibration procedures. These procedures will be copies of the Masters procedures. The front page in each of these manuals shall contain Form P370-39, the Field Document index. This form will contain the manual identification number, technician s signatory upon receipt, a list of all procedures that are enclosed by FLW Doc #, manufacturer, model number and/or description, date of entry, and initials of the person who made the entry. Only the Service Manager or Technical Manager is authorized to add new procedures to this manual Section 2 of the Master Manual Index will be used for controlling those procedures that are installed in each of the field service manuals. This section will maintain duplicate copies of Form P370-39, one for each of the manuals. The front page of Section 2 will contain Form P370-41, the Field Manual Log. This log will contain the manual number, signatory of the technician to whom the manual is issued, date of issue, initial of the person who issued the manual, date of manual return, and initials of the person verifying the return. It will be the responsibility of each of the technicians to maintain this manual as long as they are employees of FLW. Only the Service Manager or the Technical Manager shall authorize the verification of issuing and returning of a manual It will be the Service Managers responsibility for maintaining the process for controlling the Field Service Manual The laboratory shall use appropriate methods and procedures for all calibrations/verifications and related activities within its responsibility (including, but not limited to, sampling, handling, transport and storage, preparation of items, estimation of uncertainty of measurement and analysis of calibration data). a) Calibration procedures shall contain the required range and tolerance or uncertainty of each item or unit parameter being calibrated or verified. In addition, the procedures shall contain the generic description of the measurement standards and equipment needed with the required parameter, range, tolerances or uncertainties, and specification for performing the measurement of the calibration or verification, and/or representative type (manufacturer, model, option ) that are capable of meeting the generic description for the measurement standards. The procedures shall be consistent with the accuracy required, and with any standard specifications relevant to the calibrations/verifications concerned. A procedure utilized for calibration need not be the latest revision if the results of the procedure are not significantly effected by a newer revision. b) The laboratory shall ensure that the calibration uncertainties are sufficiently small so that the adequacy of the measurement is not affected. Well defined and documented measurement assurance techniques or uncertainty analyses may be used to verify the adequacy of the measurement process. If such techniques or analyses are not used, then the total (collective) uncertainty of the measurement standards shall not Calibration System Page 16 of 118 QA Manager:

17 exceed 25% of the acceptable tolerance (e.g., manufacturer s specification) for each characteristic of the measuring and test equipment being calibrated or verified. If this 4:1 ratio cannot be met due to the limitation placed by the nature of physics or technology, then a statement of ratio will be placed on the calibration report The method for finding total (collective) uncertainty will be derived by adding the relative uncertainty of the unit, plus the uncertainty of the equipment used to calibrate it. Additional uncertainties may be added where relevant, in which select methods of identifying these uncertainties have been published in international or national standards, those published by reputable technical organizations, or in relevant scientific texts of journals. These additional uncertainty factors must be identified on the certificate Where it is necessary to employ methods that have not been well established, these shall be subject to agreement with the customer, be fully documented and validated, and be available to the customer or other recipients of the relevant reports Where sampling is carried out as part of the calibration method, the laboratory shall use documented procedures and appropriate statistical techniques to select samples Calculations and data transfers shall be subject to appropriate checks. Appropriate checks may include: a) Review of calculations b) Comparison to previous results c) Review of abnormal and/or unexpected results d) Comparison of original data sheet against the final report e) Investigation of out-of-tolerance results 10.7 Where computers or automated equipment are used for the capture, processing, manipulation, recording, reporting, storage or retrieval of calibration data, the laboratory shall ensure that: a) The requirements of this Standard are complied with; b) Computer software is documented and adequate for use; c) Procedures are established and implemented for protecting the integrity of data; such procedures shall include, but not be limited to, integrity of data entry or capture, data storage, data transmission and data processing; d) Computer and automated equipment is maintained to ensure proper functioning and provided with the environmental and operating conditions necessary to maintain the integrity of calibration data; e) Data security on all service computers will be maintained in accordance to FPD 302, Section 5.3. Any changes in software utilized for maintaining records on M&TE, including software utilized for the calibration of M&TE, will be controlled in accordance to FPD302, Section and 5.5. The use of automated equipment does not relieve the Laboratory of its responsibility to meet all of the requirements of this standard 10.8 Consumable Materials Consumable materials used for the technical operation of the laboratory that can affect the results of calibrations should be purchased from an approved vendor s listing. A receipt inspection of these products is appropriate to ensure that the correct product has been delivered as specified by the purchase order. Handling and storage of this Calibration System Page 17 of 118 QA Manager: