burns quality manual

7/28/2019 Burns Quality Manual

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Burns Quality Manual

Revision H

BURNS ENGINEERING QUALITY MANUAL FORM 1102372 REVISION H

ANY PRINTED COPY OF THIS DOCUMENT IS CONSIDERED UNCONTROLLED 1 of 30


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TABLE OF CONTENTS

Change Control 3

Management Endorsement 4

4.0 System Summary (4.10) 5

4.1 Organization (4.1) 6

4.2 Quality System 7

4.3 Documentation Control (4.3) 8

4.4 Contract Review (4.4) 10

4.5 Design Control 11

4.6 Purchasing 12

4.7 Control of Customer Supplied Product 13

4.8 Product Identification and Traceability 14

4.9 Process Control 15

4.10 Inspection and Testing 18

4.11 Control of Inspection Measuring and Test Equipment 19

4.12 Inspection and Test Status 20

4.13 Control of Nonconforming Product (4.9) 21

4.14 Corrective and Preventive Action (4.11) (4.12) 224.15 Handling, Storage, Packaging, and Delivery 23

4.16 Control of Quality Records (4013) 24

4.17 Quality Audits (4.14) 25

4.18 Training 26

4.19 Servicing 27

4.20 Statistical Techniques 28

4.21 Agency Approvals 29

* Items in parentheses are cross referencing NIST Handbook 150 Checklist sections.

NOTE: Hyperlinks within this document are available internal to Burns Engineeringonly 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 QualityManual. Suggestions for changes are presented to the Engineering & QualityManager for incorporation into the document. All changes are reviewed andapproved by the President and the Burns Engineering Management Team.

Date Rev Description Approvals

President Eng Mgr Controller Mfg Mgr

Sales/Mkt

Mgr1-25-01 A New Release

JWB WHB LJK JDB KE

8-9-01 BRevised Design Control and addedFormal Process Training Program

JWB WHB LJK JDB KE

6-26-02

C

Added Design Control,

Manufacturing, Capital Equipment,and PC Support procedures, and

revised Management Reviewparagraph on page 6 JWB WHB LJK JDB KE

9-13-04 DAll sections revised for Sytelineupdates and other process changes

JWB WHB LJK JDB N/A

4-19-05 E NVLAP changes

JWB WHB LJK JDB N/A

6-13-06 FAdded detail to paragraph 4.3

regarding change control of SOPs.JWB WHB LJK JDB ST

3-31-08G Update conflict statement for

clarity and repair all hyperlinks JWB CJB LJK JDB ST

6-21-10 H

Update document review,

document retention times and Org.Chart references.. JWB CJB JWB JDB CJB




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Management Endorsement

Management supports all efforts required to comply with this Quality Manual. Thedocumentation of our quality system in this manual is Burns Engineerings commitment

to implement and achieve customer satisfaction, continuous improvement and employeeempowerment.

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, customerresponsiveness, 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 organizationand applies to all aspects of our operations.

Quality Objectives

High quality producto Engineeredo High reliabilityo Repeatableo Stable

Superior customer serviceo Custom engineered solutionso Applications supporto Order accuracyo Responsive to customer needs

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 areavailable 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 ManagementTeam 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 qualitypolicy 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 aremaintained and stored on the Burns network drive in the HR folder. These documents are

available upon request.


http://../Organization%20Chart/Current-controlled%20Org%20Chartshttp://../Organization%20Chart/Current-controlled%20Org%20Charts


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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 theBurns 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.

QualityManual

Cal Lab

Quality Manual

Procedures

SOPs, RIPs, IPIPs FIPs

(Work Instructions, Inspection Plans)

Quality Records


http://quality%20manuals/http://quality%20manuals/


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4.3 Documentation Control

Quality System Documentation

4.3.1 GeneralAll the documentation included in the quality system shall be maintained per therequirements 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. Duplicatecopies 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 eachdocument 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 tablebelow for more information.

Type Location Master file

Manuals Burns Network; Quality Manuals Yes, online

Procedures Burns Network; Procedures Yes, online

SOPs Burns Network; SOPs Yes, master copy inbooks

RIPs, FIPs,IPIPs Burns Network; Inspection Plans Yes, online

Approved Drawings Burns Network; Approved Drawings See ECO process

Other Burns Network; Quality System Yes, online

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 DocumentsQuality system documents generated in the Cal Lab shall be uniquely identified and

include the following;Date of issue

Revision identification

Page numberingTotal number of pages

Issuing authority


http://quality%20manuals/http://../Procedureshttp://../SOP'shttp://../Inspection%20Planshttp://../drawings/PDF%20Drawingshttp://../Quality%20Systemhttp://../Quality%20Systemhttp://../drawings/PDF%20Drawingshttp://../Inspection%20Planshttp://../SOP'shttp://../Procedureshttp://quality%20manuals/


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4.3.5 Documentation Changes

Documentation changes shall be evaluated and approved in the same manner the originalreview 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 anSOP 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 verifycontinued 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 theBurns 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 willbe 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 deviationon 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 Contro l

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 dummyPO 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 thestockroom. 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 thestaged job shelf with the associated job paperwork.




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4.8 Product Identi fication 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 thedrawing. 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 maintaintraceability. 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 IdentificationJob 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 andmaterial 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 andcontrolled 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 temperaturecoefficient 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 assemblytechnicians 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 special job

service

stock item 2.) Applications3.) Order

entry

element needed 4.) J obprocessing

5.) Element No element neededroom

6.) Stockroom

7.) Shop 8.) Productionfloor transmitter or

stock item needing

a reportred dot

items needing marking 9.) Calibration stock itemLab

Productionfloor

10.) Final

assembly

11.) Final Inspection anddocumentation 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 entry3.) Order entry - Order entry personnel enter the order into the database

4.) J ob processing - job processing personnel take order off database and print out the production package,

work up pick lists for special jobs5.) 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 productElement 4.9 Order placed

CustomerService

Shop

rework or reuse ProductionFloor

Scrap MRB

failed calibration CalibrationLab

Product passing+Replacements

failed in-process In ProcessInspection

Stockroom

failed final insp Final 100% IR & hi-potInspection

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. Calibrationprocedures 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 includeitems 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 Sytelineor 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 RIPnumber 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 theincoming 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.


Production job packages are stored in Customer Service area files for one year. Afterthis, 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 forequipment 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 specifiedrequirements. 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 thecalibration 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 scheduleand 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 untilrecalibrated. 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 inaccuracyor 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 section12 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, typicallyproduction 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 responsibilityand 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 bereviewed by designated Engineering representative to determine disposition in a timely

manner. A reject job may be entered with parts required list created. The reworkpackage sent to shop.

Customer returns

Products returned from customers shall be processed per the RMA Procedures. Customerapproval 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.


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 businesssystem. 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 asspecified 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 andDelivery

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 maybe 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 bestored 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 Indefinite

up on server. Electronic copy of

report also on server.

Receiving Inspection Purchasing area file cabinet Min. 5yrs

(Data also stored in computer system)

Calibration Lab Standards Cabinet in Engineering area 3 Years

Purchasing

Certificates (material, etc.) Cabinet in Engineering area Indefinite(Data also stored in computer system)

POs Purchasing area file cabinet Min 3 yrs(Data also stored in computer system)

Engineering Change Order Fire safe in Engineering area 5 Years

Test & Measurement Calibration Final Inspection area 5 Years(Non-calibration equipment)

Agency Approvals, FM, CSA, UL Fire safe in Engineering area Indefinite

Closed jobs Computer system 5 years

In-process/Final Inspection Computer system 2 years

Alpha Data from Element Room Computer system 2 years

HR Records Human Resources office Indefinite

Financial Accounting Office Indefinite

Time Cards Accounting Office 2 years(Data also stored in computer system)

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 beremoved and destroyed in an appropriate manner.

4.17 Quality Audits4.17.1 General

The following describes the process for conducting internal audits and being audited byoutside 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 aminimum, 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 atthe 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 RecordsAudit findings and concerns shall be documented in an Audit Report. Audit reports willbe 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 Training4.18.1 General

The following describes the process for training of personnel at Burns.

4.18.2 Training

Aformal process-training program is used to train employees and to maintain theirproficiency. Regular audits of each employee shall be performed to insure proficiencyand currency with processes.

Human Resources and the relevant department supervisor or manager administers the

training program and insures that each employee is properly trained.


Upon satisfactory completion of training a Certificate of Achievement is issued. Mastercopy 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 locatedon 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 aseparate Recalibration procedure covers the process as it arrives on the dock at Burns.


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 Techniques4.20.1 General

The following describes the process for using statistical methods to maintain and improvequality at Burns.

4.20.2 Sensing Element Production Tracking

Statistical techniques shall be used for control of certain characteristics of the sensingelement. 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 andinsulation 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 Approvals4.21.1 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 committedto 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, purchasedmaterials, 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 actionsIn the event a deficiency is found in Burns with regard to an outside approval agency, itwill become a priority of the Management Team to identify the cause, implement a

corrective action, and monitor for continued compliance.