Burns Quality Manual Revision H

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TABLE OF CONTENTS
Change Control Management Endorsement 4.0 System Summary (4.10) 4.1 Organization (4.1) 4.2 Quality System 4.3 Documentation Control (4.3) 4.4 Contract Review (4.4) 4.5 Design Control 4.6 Purchasing 4.7 Control of Customer Supplied Product 4.8 Product Identification and Traceability 4.9 Process Control 4.10 Inspection and Testing 4.11 Control of Inspection Measuring and Test Equipment 4.12 Inspection and Test Status 4.13 Control of Nonconforming Product (4.9) 4.14 Corrective and Preventive Action (4.11) (4.12) 4.15 Handling, Storage, Packaging, and Delivery 4.16 Control of Quality Records (4013) 4.17 Quality Audits (4.14) 4.18 Training 4.19 Servicing 4.20 Statistical Techniques 4.21 Agency Approvals 3 4 5 6 7 8 10 11 12 13 14 15 18 19 20 21 22 23 24 25 26 27 28 29

* Items in parentheses are cross referencing NIST Handbook 150 Checklist sections. NOTE: Hyperlinks within this document are available internal to Burns Engineering only and are active based on the network access of the person opening the document. Contact the Quality Manger if question or issues regarding hyperlinks. NOTE: For additional information refer to the Calibration Laboratory Quality Manual.
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Change Control Procedure The Management Team is responsible for making changes to the Quality Manual. Suggestions for changes are presented to the Engineering & Quality Manager for incorporation into the document. All changes are reviewed and approved by the President and the Burns Engineering Management Team. Date 1-25-01 Rev Description A New Release Revised Design Control and added Formal Process Training Program Added Design Control, Manufacturing, Capital Equipment, and PC Support procedures, and revised Management Review paragraph on page 6 All sections revised for Syteline updates and other process changes NVLAP changes JWB 6-13-06 F G H Added detail to paragraph 4.3 regarding change control of SOPs. Update conflict statement for clarity and repair all hyperlinks Update document review, document retention times and Org. Chart references.. WHB LJK JDB N/A
President

Approvals
Eng Mgr Controller Mfg Mgr Sales/Mkt Mgr

JWB 8-9-01 B

WHB

LJK

JDB

KE

JWB

WHB

LJK

JDB

KE

C 6-26-02

JWB

WHB

LJK

JDB

KE

9-13-04

JWB

WHB

LJK

JDB

N/A

4-19-05

JWB JWB

WHB CJB

LJK LJK

JDB JDB

ST ST

3-31-08 6-21-10

JWB

CJB

JWB

JDB

CJB

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Management Endorsement
Management supports all efforts required to comply with this Quality Manual. The documentation of our quality system in this manual is Burns Engineerings commitment to implement and achieve customer satisfaction, continuous improvement and employee empowerment.

Jim Burns
President

J.D. Burns
Manufacturing Manager

Chuck Bragg
Engineering & Quality Manager

Jim Burns (acting)

Controller

Chuck Bragg
Sales & Marketing Manager

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4.0 System Summary

Quality Policy Burns Engineering, Inc. is committed to designing and manufacturing high-quality temperature measurement products with industry leading performance and reliability. We have a focus on and a commitment to high quality products, customer responsiveness, and on-time delivery. We will accomplish this by fostering an environment of continuous improvement using a team approach and an empowered workforce. Quality Philosophy Burns Engineering, Inc. is a continuous improvement manufacturer. The quality system is the foundation of our management system and is integrated throughout the organization and applies to all aspects of our operations. Quality Objectives High quality product
o o o o Engineered High reliability Repeatable Stable Custom engineered solutions Applications support Order accuracy Responsive to customer needs

Superior customer service

o o o o

Organization All personnel manage, perform, and verify work that affects quality. Their responsibility, authority, and interrelation is defined and documented by the Burns Organization Charts and individual job descriptions. Details of responsibilities for each position listed are maintained and stored on the Burns network drive in the HR folder. These documents are available upon request. Management Representative The Engineering & Quality Manager has been granted authority by the President to: Ensure that a quality system is established, implemented, and maintained. Report on the performance of the quality system to the Burns Engineering Management Team for review and as a basis for improvement of the quality system. Management Review The Burns Engineering Management Team performs a monthly operations review including a review of the quality system to ensure continuing suitability and effectiveness in satisfying customer requirements, and conformance to the Burns Engineering quality policy and objectives. The Controller maintains records of the operations review.

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4.1 Organization
Organization All personnel manage, perform, and verify work that affects quality. Their responsibility, authority, and interrelation is defined and documented by the Burns Organization Charts and individual job descriptions. Details of responsibilities for each position listed are maintained and stored on the Burns network drive in the HR folder. These documents are available upon request.

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4.2 Quality System

Quality System 4.2.1 General The Burns Quality Manual shall be the controlling document for the quality system at Burns Engineering. The Burns Cal Lab Quality Manual shall be a supplement to the Burns Quality Manual in the Calibration area. The documentation hierarchy is shown below in a graphic format. In the case of conflict between Quality manuals on Calibration Laboratory specific topics, the Calibration Lab. Quality Manual shall govern.

Quality Manual Cal Lab Quality Manual

Procedures

SOPs, RIPs, IPIPs FIPs (Work Instructions, Inspection Plans)

Quality Records

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4.3 Documentation Control

Quality System Documentation 4.3.1 General All the documentation included in the quality system shall be maintained per the requirements of the Quality Manual. The Cal Lab Quality Manual may add other requirements but will apply to documents in the Cal Lab only. Printed copies of the online documentation shall be consider uncontrolled. Printed master copy and approved controlled copies shall be marked to indicate the status of each document. Duplicate copies of the printed master copies or other controlled copies shall be considered uncontrolled. 4.3.2 Document Approval and Issue All documents issued as part of the quality system shall be reviewed and approved for use by authorized personnel prior to use. Approvals required shall be noted on each document by job title. Individuals or alternates if unavailable with the title noted shall make documentation approvals. A master list of current approved documentation shall be available through the Burns computer network or in work instruction books in various departments. See the table below for more information. Type Manuals Procedures SOPs Location Burns Network; Quality Manuals Burns Network; Procedures Burns Network; SOPs Master file Yes, online Yes, online Yes, master copy in books Yes, online See ECO process Yes, online

RIPs, FIPs,IPIPs Burns Network; Inspection Plans Approved Drawings Burns Network; Approved Drawings Other Burns Network; Quality System

4.3.3 Document Review and Obsolete Documents will be reviewed biennially for suitability and revised as necessary per SOP G108 Document Review Procedure. Obsolete revisions of documents will be removed from the active areas and moved to a location identified for old or obsolete documents. 4.3.4 Calibration Documents Quality system documents generated in the Cal Lab shall be uniquely identified and include the following; Date of issue Revision identification Page numbering Total number of pages Issuing authority
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4.3.5 Documentation Changes Documentation changes shall be evaluated and approved in the same manner the original review was done or as otherwise documented. Changes being proposed will be communicated to authorizing personnel. To prevent unauthorized changes to SOPs, the on-line SOPs shall be located in a secure folder that is read-only for all users except those that are authorized by management to make changes. Anyone may request a change to an SOP but the only positions authorized by management to make and approve these changes are Metrology and Design Engineer, Design Engineering Supervisor, Manufacturing Engineer, and the Engineering and Quality Manager. Any changes made to quality documentation shall comply with the requirements of the Quality Manual. 4.3.6 Software Software shall be approved and issued prior to use. Appropriate individuals shall review the release to verify proper operation. Testing will be done as necessary to determine the proper operation. New releases shall be made available to users. 4.3.7 Software Changes Software changes shall be evaluated and approved in the same manner the original review was done or as otherwise controlled. Changes being proposed will be communicated to authorizing personnel. Testing will be done as necessary to verify continued proper operation. Obsolete or old versions will be removed from service and stored in a location to prevent accidental usage and archived for future reference if significant revisions were made. 4.3.8 Drawings Drawings shall be created and revised per the ECO procedure.

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4.4 Contract Review

4.4.1 General Contracts or requests for quote of temperature products and services shall be adequately defined by both Burns and the customer. Resources and processes to meet the requirements shall be reviewed and found to be adequate before beginning any work. 4.4.2 Responsibility for contract reviews (customer order or request for quotation) and contract review process Sales and Marketing department is responsible for reviewing contracts. Process is controlled by the Order Entry and Contract Review procedures located within the Burns network. 4.4.3 Control of product prices (software and printed) Customer Service controls product pricing through printed price sheets, Syteline system and with the SOPL software program. Master copies of printed price sheets Syteline data and the SOPL program are stored on the Burns computer system. 4.4.4 Control of standard and custom product specifications Product specifications are created and controlled by the Engineering department through the use of ECO controlled Mounting and Outline drawings and the software and literature list located on the Burns Network as Catalog and Software List 4.4.5 New Calibration Requests Special calibrations shall be reviewed by appropriate staff to assure that the request will be satisfied through the current or new processes. Uncertainty ranges and capabilities shall be considered in developing any new calibration process. 4.4.6 Deviations/Amendments Any variation from the specifications of products or services established in a request or contract shall be reviewed with the customer and informed on the impact of the deviation on the stated specifications. Any amendments to the contract or quote shall be reevaluated as a new one if work has started. These amendments shall be communicated to affected staff.

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4.5 Design Control

4.5.1 General The following describes the requirements for design control at Burns.

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4.6 Purchasing
4.6.1 General The following describes the process for purchasing at Burns.

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4.7 Control of Customer Supplied Products

4.7.1 General The following describes the process for handling parts supplied to Burns as a raw material or a sub assembly. 4.7.2 Responsible party and process Customer Service is responsible for coordinating shipment of no-cost parts from the customer. The receiving dock will deliver the parts to Receiving Inspection. Receiving Inspection will coordinate the receipt of parts with Purchasing. In most cases a dummy PO will be created to receive the parts and X-ref, associate to a specific requirement, them to the appropriate job. After receipt, parts and packing slip are sent to the stockroom. Parts are then issued as any other material per job order BOMs paperwork. 4.7.3 Handling and storage of product Customer supplied parts are stored in the stockroom or in Receiving Inspection on the staged job shelf with the associated job paperwork.

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4.8 Product Identification and Traceability

4.8.1 General The following describes the process for identifying Burns products and traceability of materials used in Burns products. See also Lot Tracking and Documentation Procedure 4.8.2 Raw Material and Service Job Identification and Traceability Packing slip and PO Receiving List identifies incoming parts. Parts will be inspected to the requirements of the drawing as necessary. Certificates must be provided by supplier for some items with traceable material or similar traceable characteristics per the drawing. Certificates will be stored and associated to the item, lot number and purchase order. After receipt of material into stock it will be identified and segregated to maintain traceability. Stockroom, material transactions and X-refs within Syteline system will associate and maintain lot and serial numbers of raw material to finished goods. 4.8.3 In-process Material Identification Job materials will be segregated to maintain traceability as material passes toWIP. Parts may be etched or permanently marked and have tags to identify traceability. 4.8.4 Completed Product Identification Finished assemblies will be segregated to maintain traceability. Job packages and material transactions will provide a traceability path back to raw material. Assemblies will have an identification tag attached if required. 4.8.5 Information Recorded and Storage of Records See section 4.16

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4.9 Process Control

4.9.1 General The following describes the method for manufacturing and service process control at Burns. 4.9.2 Responsibility for process control Manufacturing Manager is responsible for insuring that the process control procedures and instructions are followed. Procedures and instructions (SOP) are created and controlled by the Engineering Department. 4.9.3 Standard Operating Procedures (SOPs) SOPs are created and controlled by the Engineering department. Revision history is recorded on the individual SOP cover sheet. Masters are stored in binders in the Engineering office area with current copies maintained on the Production floor. 4.9.4 Assembly instructions and manufacturing drawings Engineering drawings control specifications and assembly instructions for all parts produced. The ECO process (reference section 4.5) controls released drawings. 4.9.5 Control of special processes Special processes are controlled by SOPs. 4.9.6 Monitoring of product characteristics during production The lead person in each assembly area monitors product quality during production. Examples include checks of resistance at 0C, insulation resistance, and temperature coefficient in addition to workmanship standards. 4.9.7 Criteria for workmanship Workmanship standards are defined by the assembly drawings and SOPs. 4.9.8 Maintenance of equipment Equipment maintenance is performed on an as needed basis. There is no formal program except for equipment in the Calibration Lab see section 4.10. 4.9.9 Welding operations - Personnel and equipment SOPs control welding operations for each type of weld made. Designated assembly technicians trained on the equipment perform the welds. 4.9.10 Records made and storage of records Completed job packages are filed for up to two years in the Customer Service area and then are moved to the cage and retained for a total of 10 years. Master copies of SOPs

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are stored in binders in the Engineering office area with current copies maintained on the Production floor.

Process flow diagrams

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Process control of standard products - Element 4.9 Contact with customer or representative

1.) Customer service stock item 3.) Order entry

special job 2.) Applications

element needed 5.) Element room

4.) Job processing No element needed 6.) Stockroom

7.) Shop

8.) Production floor

items needing marking Production floor

9.) Calibration Lab

transmitter or stock item needing a report red dot stock item

10.) Final assembly

11.) Final Inspection and documentation check

12.) Shipping

Reference element 4.12 for rejected product. 1.) Customer service - customer service personnel answer questions, take orders, pass orders to order entry 2.) Applications - Applications engineers answer questions, work on special applications, take orders, pass orders to order entry 3.) Order entry - Order entry personnel enter the order into the database 4.) Job processing - job processing personnel take order off database and print out the production package, work up pick lists for special jobs 5.) Element room - element room personnel manufacture elements per SOP's for each production package 6.) Stockroom - Stockroom attendant gathers up necessary pieces specified in production package 7.) Shop - Shop personnel manufacture subassemblies using SOP's as required in production package 8.) Production floor - Production floor personnel assemble subassemblies and pieces per SOP's 9.) Calibration Lab - Calibration technicians perform necessary procedures per SOP's as required in production package. 10.) Final Assembly - Final assemblers perform necessary procedures per SOP's as required in production package. 11.) Final Inspection - Quality technician performs necessary inspections per FIP's 12.) Shipping - Shipping clerk documents, packages, and ships product.

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Process control of select OEM product Element 4.9

Order placed Customer Service

Shop

rework or reuse Scrap MRB failed calibration

Production Floor

Calibration Lab Product passing + Replacements

failed in-process

In Process Inspection

Stockroom

failed final insp

Final Inspection

100% IR & hi-pot

use as is

Shipping

4.10 Inspection and Testing

4.10.1 General The following describes the process for inspection and test of products and services supplied by Burns.
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4.10.2 Calibration Laboratory The calibration lab technicians perform the calibration lab procedures. The calibration lab is organized per ANSI/NCSL Z-540 and NVLAP Handbook 150. Calibration procedures are documented in SOP's. Calibration certifications are stored in the fire safe cabinet. Typical certifications stored are for resistors, ASL Bridge, and SPRT data. Customer equipment calibrations include items such as probes, transmitters, etc. 4.10.3 Final Inspection The Quality Assurance Technician performs final inspection. Final inspection is done per FIP's, requirements on the job package drawing, part number drawing, and Customer Acknowledgement sheet. Non-conformances and defects are documented in the Syteline or documented in the Inspection Defect Database. 4.10.4 Receiving Inspection The Quality Assurance Technician performs receiving inspection. Inspection is performed per RIP's, SOP's, and drawing specifications. If a RIP is required, the RIP number is specified on the PO Receiving List. Inspection stores hard copies of electropolish certifications, material certifications, and test information for platinum wire, elements, thermocouple wire, and MI cable. The calibration lab stores the raw data on the server of tests performed as required per the incoming inspection SOP's. 4.10.5 In-Process Inspection In process inspection is done by both QA and the Calibration Lab per SOP's, IPIP's and per the route sheet. The production package has checklists of dated and signed-off processes and in-process and final inspections. 4.10.6 Records made and storage of records Production job packages are stored in Customer Service area files for one year. After this, they are stored in archive boxes in the cage.

4.11 Control of Inspection and Test Equipment

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4.11.1 General The following describes the general process for controlling inspection and test equipment used at Burns. The Burns Calibration Quality Manual adds additional detail for equipment used in the Lab. 4.11.2 Measurement Inspection, measuring and test equipment (including test software) shall be controlled, calibrated, and maintained to assure conformance of material and product to the specified requirements. The calibration system is designed to meet the requirements of ANSI/NCSL Z-540 and NVLAP Handbook 150. The system is open for customer verification and audit. 4.11.3 Traceability Probes and equipment shall be traceable directly back to NIST or by a report from the calibration vendor or internal calibration process. 4.11.4 Identification Equipment requiring calibration shall be identified by a calibration sticker or engraved number or similar identification mark and referenced to the tool calibration software. The tool software program on the computer system maintains the calibration schedule and uses the tool identification number. Any new equipment that requires calibration shall be added to the computer system. 4.11.5 Out-of-Calibration Assessment A periodic review or report shall be run to maintain calibration of tools. Tools identified on the report shall be recalibrated as necessary. If tools are found out-of-calibration they shall identified as out of calibration and isolated if possible to prevent use until recalibrated. Calibrations shall be done internally per SOP's or by external calibration service companies. 4.11.6 Environmental Control Temperature and humidity in the Calibration Lab shall be monitored, recorded, and kept on file in the Calibration Lab. (see Calibration Quality Manual for more details) The environment of other areas shall be maintained to minimize, any measurement inaccuracy or adversely affect the quality of the measurement. 4.11.7 Records and Storage of Records Equipment Calibration Certifications shall be filed and stored per section 4.16 or section 12 of the Calibration Quality Manual.

4.12 Inspection and Test Status

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4.12.1 General The following describes the process for Inspection of products and services at Burns. A checklist on the job package identifies inspection and test status of production parts. Nonconforming parts are labeled with a tag indicating the problem. Rejected parts shall placed on the; reject shelf in Production, Cal Lab and the MRB shelf in QA. The reject information shall be entered into the business system. Anyone can reject a part, typically production personnel, quality technician, or calibration technician.

4.13 Control of Non-Conforming Product

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4.13.1 General The following describes the process for 4.13.2 Responsibility for Review/Disposition of Nonconforming Product RMA Team and MRB Team along with the QA Manager shall have the responsibility and authority for review and disposition of nonconforming product. Periodically, annually at a minimum, a review of reject data shall be done and take action as appropriate to resolve problems. 4.13.3 Identification, Documentation, Evaluation, Segregation, and Disposition of Nonconforming Products Reject/Rework from Production floor Parts rejected shall be labeled with tag or segregated. A reject number may be assigned and parts placed on reject shelves in Production or Calibration area. The reject shall be reviewed by designated Engineering representative to determine disposition in a timely manner. A reject job may be entered with parts required list created. The rework package sent to shop. Customer returns Products returned from customers shall be processed per the RMA Procedures. Customer approval shall be obtained for out-of-warranty products that are reworked, repaired, or scrapped. Product returns having a potential product safety concern are brought to the attention of the quality manager for appropriate action. 4.13.4 Records made and storage of records Reject data shall be stored on the computer system. Records of the rework jobs are stored in business system as any other job. RMA data is entered and stored on business system. See section 4.16 for additional details on records.

4.14 Corrective and Preventative Action

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4.14.1 General The following describes the process for preventative and corrective actions at Burns. 4.14.2 PCAR System Preventive and Correction Action Request (PCAR) Form #347 shall be used to record and assign action items as required to resolve the problem. Forms are filled out as specified in PCAR Procedure. QA manager or designee shall be responsible for ensuring PCAR is completed. 4.12.3 Records Made and Storage of Records Completed forms are assigned a number and filed. Action taken is at discretion of the QA manager.

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4.15 Handling, Storage, Packaging, Preservation and Delivery

4.15.1 General The following describes the methods to preserve material used with in Burns. 4.15.2 Handling Purchasing may verbally communicate any special handling requirements of purchased material to the vendor. Information may also be listed on the piece-part or assembly drawing for material in stock or WIP. 4.15.3 Storage Designated storage areas and stockroom are used for storage of parts. Some items may be staged near assembly areas. If necessary, to maintain the quality of the material it may be stored in special conditions such as a freezer, sealed container, or at elevated temperature. 4.15.4 Packaging Shipping staff is trained in standard packaging procedures for each type of assembly. Customer Service advises shipping department of special packaging procedures as specified by the purchase order. 4.15.5 Preservation If necessary the shelf life of materials shall be controlled to ensure the quality of the material at the time of use. If necessary, to maintain the quality of the material it may be stored in special conditions such as a freezer, sealed container, or at elevated temperature. 4.15.6 Delivery Delivery of materials shall be arranged by Purchasing and be communicated verbally or on PO documents to the vendors. 4.15.7 Records made and Storage of Records The Purchase Order shall be stored for three years minimum. See also section 4.16

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4.16 Control of Quality Records

4.16.1 General The following describes the duration for storing records at Burns.
Record Location Retention Time

Calibration

Calibration computer and backed up on server. Electronic copy of report also on server. Purchasing area file cabinet (Data also stored in computer system) Cabinet in Engineering area

Indefinite

Receiving Inspection

Min. 5yrs

Calibration Lab Standards Purchasing Certificates (material, etc.) POs

3 Years

Cabinet in Engineering area (Data also stored in computer system) Purchasing area file cabinet (Data also stored in computer system) Fire safe in Engineering area Final Inspection area

Indefinite Min 3 yrs

Engineering Change Order Test & Measurement Calibration (Non-calibration equipment) Agency Approvals, FM, CSA, UL Closed jobs In-process/Final Inspection Alpha Data from Element Room HR Records Financial Time Cards

5 Years 5 Years

Fire safe in Engineering area Computer system Computer system Computer system Human Resources office Accounting Office Accounting Office (Data also stored in computer system)

Indefinite 5 years 2 years 2 years Indefinite Indefinite 2 years

4.16.2 Disposal of Records

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Periodically, approximately 2 year period, records will be evaluated for disposal per the above retention periods. Electronic records will be deleted. Hard copy documents will be removed and destroyed in an appropriate manner.

4.17 Quality Audits

4.17.1 General The following describes the process for conducting internal audits and being audited by outside agencies or customers. 4.17.2 Responsibility and Authority for Conducting Internal Audits The Quality department as directed by QA Manager will periodically, annually at a minimum, conduct internal audits. It will have the responsibility and authority to audit and review corrective actions generated by the audits. It will also have the responsibility and authority to identify areas of concern. Results will be communicated to the management team following the audit and review. 4.17.3 Selection of Internal Audit Area and preparation Areas to be audited shall be selected to comply with; agency approvals, to monitor areas with special concerns, verify previous audit issues, or randomly. An auditor shall be selected that is independent of the area, knowledgeable of the area and with good audit techniques. Audit questions shall be formally or informally prepared before the audit at the auditors discretion. The internal audit schedule will be maintained by the Mr. Tool program. The details of this recall system are available upon request. Contact a member of the Quality team for assistance. 4.17.4 Records and Storage of Records Audit findings and concerns shall be documented in an Audit Report. Audit reports will be stored on the server for a minimum of 2 years in the Internal Audits subfolder of the Quality System folder. Audit corrective actions shall also be recorded on the Audit Report. 4.17.5 External Audits Customers or their representatives shall be given access to audit the quality system and relevant areas at Burns. Burns shall cooperate to offer information on the performance of quality system, products and services.

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4.18 Training
4.18.1 General The following describes the process for training of personnel at Burns. 4.18.2 Training A formal process-training program is used to train employees and to maintain their proficiency. Regular audits of each employee shall be performed to insure proficiency and currency with processes. Human Resources and the relevant department supervisor or manager administers the training program and insures that each employee is properly trained. 4.18.3 Records Made and Storage of Records Upon satisfactory completion of training a Certificate of Achievement is issued. Master copy is issued to the trainee and a copy is filed with Human Resources. Successful completion of an audit is noted on the master and Human Resources copy of the Certificate of Achievement. Training documents are stored on the computer system and a hard copy is stored by Human Resources.

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4.19 Servicing
4.19.1 General The following describes the process for service support by Burns. Servicing consists of items returned to Burns Engineering Inc. for calibration or returned for other reasons. 4.19.2 Returned Material Procedure Parts returned from customers shall be handled according to the RMA procedure located on the computer system. Return numbers and return information are maintained through the Syteline system on the server. Username and password control access to the Syteline system and information in the policy and procedure controls who may issue RMAs. 4.19.3 Probes Returned for Calibration Probes returned for calibration are handled with the same RMA method. However a separate Recalibration procedure covers the process as it arrives on the dock at Burns. 4.19.4 Records Made and Storage of Records Records of returns are stored on the server and are backed up daily by the computer system. Calibration information is retained as specified in section 4.11 and 4.16. The Quality Manager reviews return information periodically.

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4.20 Statistical Techniques

4.20.1 General The following describes the process for using statistical methods to maintain and improve quality at Burns. 4.20.2 Sensing Element Production Tracking Statistical techniques shall be used for control of certain characteristics of the sensing element. SOPs define the specific procedures that are followed. Test data is entered and stored on the computer system and to determine acceptance of the lot. Engineering and or the Quality manger shall be consulted for questions regarding acceptance. 4.20.3 Test program for All Probes Each temperature probe produced shall be 100% checked for accuracy at 0C and insulation resistance as a minimum. Additional tests and calibration may be done as required. 4.20.4 Other Test Plans Problem solving or quality improvement efforts shall make use of statistical methods. These methods can be used to identify trends, variation and uncertainty of measurement.

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4.21 Agency Approvals

4.21.1 General The following describes the process for dealing with external agencies at Burns. 4.21.2 Commitment to Various Agency Approvals Burns Engineering is committed to delivering high levels of quality in design, materials, fabrication processes, calibration services and finished products. Burns is also committed to ethical practices to meet or exceed the requirements of outside approval bodies. Internal processes and procedures will be followed to comply with the approval bodys rules and guidelines. Those processes and procedures may include drawings, purchased materials, manufacturing techniques, and test or inspection processes. Any changes made to approved items will be changed in a documented and appropriate manner. Efforts will be made to ensure this is consistently done to prevent any deficiencies. Agency auditors will be given access to review Burns practices as necessary. 4.21.3 Customers and Customer Representatives The same commitment to outside agency shall apply to Burns customers and representatives of Burns customers. See also section 4.17.5 External Audits 4.21.4 Corrective actions In the event a deficiency is found in Burns with regard to an outside approval agency, it will become a priority of the Management Team to identify the cause, implement a corrective action, and monitor for continued compliance.

BURNS ENGINEERING QUALITY MANUAL FORM 1102372 REVISION H ANY PRINTED COPY OF THIS DOCUMENT IS CONSIDERED UNCONTROLLED

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