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

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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 Powered By Docstoc
					            Burns Quality Manual

                        Revision H




BURNS ENGINEERING QUALITY MANUAL FORM 1102372 REVISION H
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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)                      22
4.15 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 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      Rev Description                                            Approvals
                                                                                                Sales/Mkt
                                                   President   Eng Mgr   Controller   Mfg Mgr      Mgr
1-25-01   A    New Release
                                                   JWB         WHB        LJK          JDB        KE
               Revised Design Control and added
8-9-01     B
               Formal Process Training Program
                                                   JWB         WHB        LJK          JDB        KE
               Added Design Control,
               Manufacturing, Capital Equipment,
           C   and PC Support procedures, and
6-26-02        revised Management Review
               paragraph on page 6                 JWB         WHB        LJK          JDB        KE
               All sections revised for Syteline
9-13-04   D
               updates and other process changes
                                                   JWB         WHB        LJK          JDB       N/A

4-19-05    E   NVLAP changes
                                                   JWB         WHB        LJK          JDB       N/A
               Added detail to paragraph 4.3
6-13-06    F
               regarding change control of SOPs.
                                                   JWB         WHB        LJK          JDB        ST
               Update conflict statement for
          G
3-31-08        clarity and repair all hyperlinks   JWB         CJB        LJK          JDB        ST
               Update document review,
6-21-10   H    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. The
documentation of our quality system in this manual is Burns Engineering’s 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   Engineered
           o   High reliability
           o   Repeatable
           o   Stable
   •   Superior customer service
           o   Custom engineered solutions
           o   Applications support
           o   Order accuracy
           o   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 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


                                SOP’s, RIP’s, IPIP’s FIP’s
                             (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                   Location                                     Master file
Manuals                Burns Network; Quality Manuals               Yes, online
Procedures             Burns Network; Procedures                    Yes, online
SOP’s                  Burns Network; SOP’s                         Yes, master copy in
                                                                    books
RIP’s, FIP’s,IPIP’s 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 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.



                 Define project at the discretion of the
                            project leader.




                       Create design documents
                     (Drawings, BOM’s, Routings)




                    Design review is accomplished
                  through the ECO sign-off process.


                                                           Exception:
                                                           Existing design packages meaning that
                                                             they have been built previously and
                 Design verification and validation is            have some type of design
                   left to the discretion of the project       documentation, may be entered
                 leader. No formal documentation is          directly into the CAD and computer
                                 required.                  system, bypassing the ECO process.
                                                            Drawings, BOM’s, and routings may
                                                            not be revised, they shall be entered
                                                               “as is”. Design changes remain
                                                            controlled through the ECO process.


                    Design changes are controlled
                     through the ECO process.




                    ECO’s are kept on permanent
                  record. Test reports, if created are
                 kept on permanent record. Files are
                 maintained in the Engineering Area.




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




                                          Purchasing creates P.O. per system
                                          requirements. Order is placed with
                                            supplier. Paperwork is filed in
                                             Purchasing department. See
                                            purchasing procedure for more
                                                        detail.




                                        When parts arrive on receiving dock,
                                        the receiving list is printed and sent
                                        to Inspection or stock as indicated.




                                          Parts are inspected. See receiving
                                            inspection procedure for more
                                                        details.
 Parts are reworked
   as necessary.




                                 Reject              Inspection?               Accept

      Rework

                                                                        Part is sent to stockroom with
                 Part is reviewed for disposition.
                                                                         paperwork where they are
                RTV parts are returned to supplier
                                                                   transacted into stock and paperwork
                 by Purchasing with necessary
                                                                      is sent to Accounting for invoice
                            paperwork.
                                                                                  processing.




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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 BOM’s 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 (SOP’s)
SOP’s 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 SOP’s.

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 0°C, 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 SOP’s.

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

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              Process flow diagrams



Process control of standard products - Element 4.9

                                          Contact with customer or representative


                                                          1.) Customer           special job
                                                              service
                                                  stock item                                            2.) Applications

                                                           3.) Order
                                                             entry


                        element needed                      4.) Job
                                                          processing
          5.) Element                                           No element needed
              room
                                                      6.) Stockroom




           7.) Shop                                     8.) Production
                                                             floor                         transmitter or
                                                                                        stock item needing
                                                                                             a report
                                                                                                           red dot
                items needing marking                   9.) Calibration                                  stock item
                                                             Lab
           Production
              floor
                                                          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       Production
                                                      Floor
Scrap                MRB

                              failed calibration    Calibration
                                                       Lab
                                                                  Product passing
                                                                  + Replacements
                              failed in-process     In Process
                                                    Inspection


                                                   Stockroom



                              failed final insp        Final      100% IR & hi-pot
                                                    Inspection


                  use as is                          Shipping




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                                                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.

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.




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                4.11 Control of Inspection and Test Equipment
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.




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                                                      4.12 Inspection and Test Status
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.




                                 Cal Lab or
                                                               Inspection or RMA
                                 Production

          To Shop or
        Production Floor
          Work Center




                                 Reject Shelf                       MRB Shelf
            Rework                                     Scrap
                           (on Prod. Floor and Lab)            (in Inspection area)




        Create Rework              Accept
                                                                     Rework
             Job

                              Production Floor
                             or next routed area                 Work Center to
                                                                    rework
                                                                                      Use As Is



                                 Final Assy




                               Final Inspection                 Stockroom/Cage




                                  Shipping




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                         4.13 Control of Non-Conforming Product
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.




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                           4.14 Corrective and Preventative Action
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         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)
•   PO’s                             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)




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4.16.2 Disposal of Records
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 auditor’s 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 RMA’s.

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. SOP’s 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 0°C 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 body’s
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.




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