ML20044A862
| ML20044A862 | |
| Person / Time | |
|---|---|
| Site: | 07100702 |
| Issue date: | 06/11/1990 |
| From: | Gregory L GREGORY ENTERPRISES, INC. |
| To: | |
| Shared Package | |
| ML20044A861 | List: |
| References | |
| GEIQA-01-90, GEIQA-1-90, NUDOCS 9007160213 | |
| Download: ML20044A862 (28) | |
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031 10>CFR 71, SUBPART D, QA PROGRAM PG 1 OF 27
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10 CFR 71, SUBPART W QUALITY ASSURANCE PROGRAM FOR FABRICATION j
oF SMIELDED TRANSPORTATION CONTAINERM I
i l
i LETTER NUMBER GRIQA-01-90 REVISION 0 1
JUNE 11, 1990 Gregory Enterprises, Inc.
l Robbs Nighway
)
l Box 2308 i
Carlsbad, NM 88220 j
APPROVALS i
1 REVISION l
PRESIDENT /DATE l
QA MANAGER /DATE l
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CBI" 10 CFR 71, GUBPART N, QA PROGRAN PG 2 OF 27 e
INTRODUCTION Gregory Enterprises, Inc. has developed a Quality Assurance Sys-tem to assure traceability and control the quality of all materials and processes utilized in the fabrication of radio-active shielding, casks, containers, and related structures, systems and components.
The Quality Assurance Manual delineates policies and requirements (Quality Policies) and detail procedures (Quality Instructiont.)
necessary to exercise control over documentation, procuremen:,
- material, fabrication, inspection, and quality data retentien.
Please also see Criterion 2,
" Quality Assurance Program" for Quality Manual Discussion.
Gregory Enterprises, Inc.'s QA System and implementing Qua'.ity Procedures (QP) are designed and administered to meet the requirements of 10 CFR 71, Subpart H.
Figure 1 is a matrix delineating the relationship between the sixteen (16) Gregory Enterprises, Inc. QPs and the eighteen (18) criteria of 10 CFR 71, Subpart H.
The following is a synopsis of the current Gregory Enterprises, Inc. QA System.
This is the basic system utilized on all 10 CFR 71, Subpart H
related fabrication programs at Gregory Enterprises, Inc.
DESCRIPTION OF THE GEI 10 CFR 71 SUBPART H QA SYSTEM Criterion h Oraanisation Full responsibility for the Quality Assurance (QA) Program ad-herence to 10 CFR -71, Subpart H criteria rests with Gregory Enterprises, Inc..
Selected QA Program activities are performed-by GregJry Enterprises, Inc QA approved suppliers. These include calibrt. tion of measuring equipment, NDE and materials testing.
Gregory Enterprises, Inc. surveys and qualifies all organizations performing these services to assure adherence to the 18 criteria prio'/ to their use. However, the responsibility of the control of QA An the other organizations continues to rest with Gregory iEnterprises, Inc..
i
GEI 10 CFR 71, SUBPART M, QA PROGRAN PG 3 OF 27 All other QA activities such as quality instruction preparation, in-process and final acceptance inspections, MRB activities, data review and retention, etc.,
are performed directly by cregory Enterprises, Inc. QA directed and approved personnel.
Gregory Enterprises, Inc.'s President has full authority over all functions of the
- company, and delegates authority and responsibility for selected functions to other personnel within the company.
Administrative functions include financial and legal activities.
Marketing activities are performed by senior management and technical personnel reporting directly to the President.
They are charged with the duty to identify and develop new business for Gregory Enterprises, Inc.
Procurement functions are performed by GEI personnel assigned to purchasing activities.
These personnel maintain supplier performance records.
Any engineering that may be required by Gregory Enterprises, Inc. is provided by the customer, or engineering suppliers that are qualified to perform the engineering specified.
These sup-pliers appear on the Gregory Enterprises, Inc, Approved Suppliers List (ASL) as being so qualified.
The Gregory Enterprises, Inc.
QA Department has complete 1
authority and organizational freedom to identify QA problems, establish QA programs, implement corrective action and verify corrective action effectiveness.
Additionally, GEI personnel performing QA/QC functions are assigned and approved by the QA Manager and the President. They are independent from other organizations and functions within Gregory Enterprises, Inc. and report directly to the QA Manager and the Treeident of Gregory Enterprises, Inc..
The (.A Department is headed up by the QA Manager who is'respons-ible for the development, implementation and administration of the total Gregory Enterprises, Inc. QA Program and all related activities and functions.
The QA Manager must have sufficient expertise in the entire field of Quality to enable him to direct l
the entire QA-function in close adherence to the 18 criteria and the Gregory Enterprises, Inc. QA Manual.
GEI 10 CFR 71, SUBPART M, QA PROGRAM PG 4 OF 27 I
The QA Program and supporting QA Manual and procedures developed l
by the QA Manager are approved by the President of Gregory Enter-prises, Inc..
Please also see Criterion 2,
" Quality Assurance Program" for Quality Manual Discussion.
e l
Responsibility for development of QA acceptance requirements, inspections, and NDE activities rest with the QA Manager. It is i
also his responsibility to delegate and evaluate the performance of all QA related task $ for Gregory Enterprises, Inc. through the authority of the President.
In written directives, the QA Manager designates GEI personnel j
with authority to perform QA functions that prevent the continued I
processing, fabrication, installation or delivery of unsatis-l factory work.
q QA authority also extends to the monitoring of special processes utilizing Gregory Enterprises, Inc. equipment, personnel and j
procedures such as testing, field erection, welding, machining processes, painting, etc.
Production responsibilities include scheduling of inspection and administration of all fabrication activitics, both within Gregory Enterorises, Inc. and at qualified suppliers.
The shipping and receiving function is also the responsibility of personnel i
cognizant of the production activity but is performed through the Procurement activity.
On-site activities such as field inspections, field testing programs, field welding, etc. are administered as a joint effort of the QA/QC and Production personnel of Gregory _ Enterprises, Inc.
i and QA approved contractors as required.
The Gregory Enterprises, Inc. QA Department supports these activ-ities with written procedures that provide methods, process con-trols and check points.
Inspection personnel perform monitoring l.
activities and verifications of regulatory, contractual and tech-nical requirements during these operations.
The QA Manager and all GEI personnel assigned by the QA Manager to QA functions within, or utilized by Gregory Enterprises, Inc.,
are fully qualified for their QA responsibilities.
Qualification records are maintained in the Gregory Enterprises, Inc. QA Record File.
-Figures 2A and 2B provide general Gregory Enterprises, Inc.
Organization Charts for the company and the QA function in par-ticular.
1 l
l l.
I S31 10 C;'R 71, SUSFART N, QA PROGRAN PG 5 OF 27
'i criterion L, Quality Assurance Program Gregory Enterprises, Inc. has established and implemented a QA-Program for the control of quality in the fabrication of shielded l
transportation containers for nuclear products. The QA Program is j
documented in the Gregory Enterprises, Inc. QA manual.
i The QA Manual is comprised of two separate but interrelated documents as follows:
j QUALITY POLICY (QP):
This document is relatively brief and includes a series of QPs.
The intent of it is to provide an official Gregory Enterprises, Inc. ove W iew of what QA is to.
3 the company, and who has the responsibilities for it.
It is informative and concise.
The basic 18 criteria of 10 CPR 71, Subpart H are addressed in sufficient detail to assure accurate and complete dissemination of the QA requirements to all Gregory Enterprises, Inc. personnel, its customers 1
and suppliers.
l The QPs provide a standard reference for QA that all person-I nel and suppliers receive and refer to for basic information on the Gregory Enterprises, Inc QA process.
l This enables all personnel and suppliers to grasp the intent l
of the Gregory Enterprises, Inc. QA System and become part of the QA program. This allows everyone to become respon-sible for quality in their individual work.
l QUALITY INSTRUCTIONS (QI):
These are a series of specific
{
Quality Related procedures prepared to implement the Quality policies.
They directly reflect the specific ways that Gregory Enterprises, Inc. addresses quality planning, in-spection, calibration, testing, special process qualifica-l tion and control (such as welding, NDE and painting), ma-L terial control, documentation control, discrepancy control, procurement control, personnel training, etc.
The format allows revision of existing QIs and addition of new ones in response to corporate, contractual or regulatory
.l demands.
l The QI System is designed to allow revision without disrup-tion of the Basic Quality Policies of Gregory Enterprises, Inc.
Quality of documentation, procurement, product, services and the l
reputation of Gregory Enterprises, Inc. is the responsibility of every employee, orientation of each employee emphasizes this fact.
t i
s
f SEI 10 CFR 71, SUBPART N, QA PROGRAN PG 6 0F 27 1
I All personnel in the company are provided with, or have direct access to, controlled copies of the OA Policy (Qp) and also have access to the entire QA Manual. They are required to adhere to it's requirements in all applicable activities.
The main precept of Gregory Enterprises, Inc. QA is that quality must start with the award of the fabrication contract and proceed with it all the way to the final product or service to assure complete adherence to the regulatory and contractual criteria of the Nuclear Industry.
)
i To this end, training and/or evaluation of personnel qualifica-tions are required for all QA and quality related functions in accordance with written procedures and are approved by the QA i
Manager.
j These procedures require that qualification and training status
)
records be retained in the QA Personnel record file under the i
control of the QA Manager.
This requirement pertains to all Gregory Enterprises, Inc. personnel and Gregory Enterprises, Inc.
supplier and contract personnel involved in QA related activities.
The data retained in the qualification record includes: diplomas, resumes, certifications, test scores, work performance evalua-tions and other related data attesting to the individual's QA related expertise and capabilities. Other details such as, certi-fication dates of issue and expiration and requirements for re-certification are also retained in the qualification records for each individual.
The data is evaluated and updated annually.
Additional training, orientation and or schooling is specified by the QA Manager when impending personnel assignmont changes and/or contractual or regulatory applications justify it.
The QA Program assures that all quality requirements, engineering specifications, and specific provisions of any applicable package design approval are met during fabrication.
Those characteris-tica critical to safety are emphasized as directed by the appli-cable Topical and Safety Analysis Reports and design and fabrica-tion drawings referenced or supplied by the customer for the licensed product being fabricated Based on this information, Quality Levels are established for all QA related activities during the QA inspection planning, fabrica-tion, testing, documentation and general inspection phases of a contract.
1 Use of this graded approach to QA system implementation assures proper QA system utilization on all activities.
i
'GEI 10 CFR 71, SUBPART C, QA PROGRAN PG 7 0F 27 1
The President of Gregory Enterprises, Inc. regularly evaluates
]
the Gregory Enterprises, Inc. QA program for adherence to the 18 criteria of 10 CFR 71, Subpart H in scope, implementation and effectiveness via internal audits as delineated in criterion 18 of this synopsis.
Further, the President requires that the QA l
System, including the QA Manual Policies and Procedures, be impl-emented and enforced on all applicable programs at Gregory Enter-prises,'Inc.
Please also see also Criterion 16, " corrective Action".
All discrepancies in materials, hardware and/or processes occur-
]
ring during fabrication activities are reported in writing and 1
dispositioned by an established Material Review Board (MRB).- MRB members are approved by the President and QA Manager of Gregory Enterprises, Inc.
Their selection is based on MRB member quali-fications in the area of expertise and responsibility required 4
for the dispositions. MRB dispositions are final and binding.
Please.also see also criterion 15, "Nohconforming Materials, Parts or Components" for further discussion about the MRB.
Criterion h Desian ContrJtl i
Gregory Enterprises, Inc. does not provide designs.
Therefore, this criterion is not spa tifically addressed.
However, proce-dures are in place to assure adherence to design and fabrication documentation and criteria provided for fabrication by customers and/or regulators.
Please see criterion 6,
" Document Control" 'for discussion on control of design documentation such as specifications, pro-cedures and drawings.
l criterion h Procurement QftggggM pontrol The Gregory Enterprises, Inc. QA Program assures that al'l' pur-chased material, components, equipment, and services adhere to design specifications, regulatory and contractual requirements.
Supplier evaluation and selection, objective evidence of supplier quality, assignment of quality requirements to procurement docu-ments and related design documents, and source, in-process and receiving inspection are all administered and controlled in ac-cordance with approved Gregory Enterprises, Inc. QA procedures.
l l
ll-
031 10 CFR 71, S~JBPART N, QA PROGRAM-PG 8 OF 27 l
All procurement activity ic performed in accordance with written I
procedures delineating requirements for preparation, review, approval and control of procurement documentation.
Particular emphasis is placed on assuring that revisions to pror.;urement documentation are reviewed and approved by the same cognizant i
groups as the original.
i The QA department checks procurement documents for complete re-view and approval by the cognizant personnel in accordance with i
written QA procedures pertaining to the procurement function prior to QA approval.
l QA clause sheets are included with all request for quotes and i
purchase orders.
QA personnel assign clauses from the sheets to i
the procurement document referencing 10 CFR Part 71, Subpart H, j
requ:.rements appropriate to the contract.
j f
Material information including grade, type, size and physical and chemical data requirements is included on the procurement - docu-ments. Review of the data includes verification of the suitabil-1 ity of standard items for the use delineated on the applicable drawings and design specifications and inclusion of valid indus-try standards, references and related data when applicable.
J Other documentation requirements and information such as draw-ings, procedures, material test data and certifications, inspec-tion and test requirements, hold points, welding and.other pro-
]
cess' qualification requirements and personnel qualifications are delineated, or verified to be present, on the procurement docu-ments by QA personnel as appropriate to the contract.
QA personnel assure that requirements for acceptance of hardware and documentation, such.as Gregory Enterprises, Inc. and/or supplier submittal and retention instructions, appropriate to the contract are included in procurement documentation.
Gregory Enterprises, Inc. QA personnel maintain the right of access to supplier facilities and documentation for source in-spection and/or audit activities.
A statement to this effect is included on procurement documentation when it is appropriate to the contract.
The defect and noncompliance reporting requirements of 10 CFR 21.21 are delineated in writing to all Gregory Enterprises, Inc.
1 suppliers and sub-contractors.
i i
1-
- - - - + - - -
i I
GEI 10 CFR 71, SUBPART N, QA PROGRAN PG 9 OF 27 I
1 i
criterion h Instructions, Procedures and Drawinas
.j i
QA Inspection Planning is developed for all activities requiring
]
current approved design configuration and/or performance verifi-cation, witnessing, measurements,
- testing, audits or other QA related activities in accordance with approved Gregory Enterprises, Inc. QA procedures by qualified Quality Engineers (QE). These instructions are approved by the QA Manager.
All documents, i.e.,
drawings, specifications, special processes, test and calibration procedures, etc. affecting quality are re-
)
viewed by the QA Department and referenced in QA Inspection Plan-ning as necessary to assure adherence to package design approvals and the applicable criteria of 10 CFR 71, Subpart H for the pro-s duct being fabricated.
QA Inspection Planning also includes acceptance criteria appro-priate to the subject matter of the instruction such as dimen-
- sions, tolerances, operating
- limits, weld
- criteria, NDE l
requirements, workmanship standards, and other related qualitative and quantitative data.
[
All instructions, procedures,
&nd drawings are developed, re-viewed, approved, utilized and controlled in accordance with the requirements of written ~-QA procedures.
Please also see criterion 6,
" Document control".
Criterion 1.4. Document control Policy and procedure for review, approval, release and change control of all controlled, QA related documents are delineated in approved Gregory Enterprises, Inc.
QA Procedures.
These pro-cedures establish review and approval cycles and sequences and require that all such approved documents are subjected to the same approval cycle and sequence when revised.
Provisions are provided in the QA - Procedures for identification of individuals or organizations responsible for review, approval and issuance of documents.
Document control responsibilities and distribution requirements are also addressed.
Transmittal sheets with receipt acknowledgment provisions are utilized to assure proper controlled document transmittal and receipt records maintenance for original issues and subsequent revisions.
~
y 031 10 CPR 71, SUBPART N, QA PROGRAM PG 10 OF 27 L+
controlled documents include, but are not limited to:
(a)
Design manufacturing drawings.
(b)
Fabrication drawings (c)
Special process specifications and procedures.
(d)
General procudures for activities in production, pro-curement, document control, training, etc.
(e)
(f)
QA Policies and Instructions.
(g)
All QA Inspection Planning.
(h)
Materials data.
(i)
NDE data.
(j)
Source surveillance and evaluation reports.
(k)
Test procedures.
(1)
Audit reports.
(m)
Operational test procedures and data.
(n)
Non-Conformance Reports (NCR), completed or blank.
When revised documents appear in other documents as references, supplements or exhibits, appropriate revisions are made to those documents prior to the release of the basic approved change.
Documentation listings are maintained delineating the title, number and current revision for all drawings, procedures, speci-fications, and purchase orders.
QA and Document control Personnel assure that all required sup-port documentation of the correct revision is available at the work area prior to the initiation of the work effort. A system of drawing status indicators such as " Controlled", " Uncontrolled",
" Certified for Construction",
" Inspection Record Copy",
etc.,
have been developed and implemented.
In addition, documentation revision and type requirement verifi-cation steps have been established, in writing, by Document Control and QA personnel to assure correct documentation use.
GRI 10 CFR 71, SUBPART N, QA PROGRAM PG 11 0F'27' criterion h control 21 EgIshased Materials Parta and Components Procurement documents are reviewed for acceptability of suggested suppliers based on the Gregory Enterprises, Inc. approved sup-plier lists.
In addition, and as required, supplier surveys are conducted by qualified Gregory Enterprises, Inc. personnel to further assure supplier acceptability.
These evaluations are based on one or all of the following criteria and are performed by the organiza-tions noted (a)
The capability of the supplier to comply with the re-quirements of 10 CFR Part 71, Subpart H,
that are applicable to the contract. (Quality Assuranco)
(b)
A review of previous records and performance of the supplier. (Quality Assurance and Procurement)-
(c)
A survey of the supplier's facilities and QA program to determine his capability to supply a product which meets the design, manufacturing, and quality require-ments. (Quality Assurance, Procurement and Production)
Results of all supplier evaluations are recorded on Supplier Evaluation forms and are retained in the QA Data File.
Annual audits are conducted at active' supplier's facilities dur-ing, but independent of, source inspection activities to assure continued adherence to Gregory Enterprises, Inc.
imposed QA, design and contract performance criteria.
QA requirements and standard clauses are ' added to procurement documents to require suppliers to identify material, provide test reports, control special processes, certify equipment and person-nel, etc.
Requirements to identify material and specific codes, specifica-tions and/or design requirements pertaining to the fabricated items and procurement specifications not adhered to, with justi-fication for " accept-as is" or " repair" dispositions, are imposed on suppliers as a minimum.
QA Inspection Planning is prepared and approved by the QA Depart-ment for performance of all receiving, source, in-process, test and/or shipping inspections in accordance with approved designs, applicable 10 CFR 71, Subpart H criteria, procurement document requirements and contract specifications.
Please also see criterion 5,
" Instructions, Procedures and Drawings".
s
1 y=
SSI.10 CFR 71, CUSPART O, CA. PaoGRAN PG 12 OF 27 Receiving inspection is performed by Gregory Enterprises, Inc. QA personnel to determine that the following, as appropriate to the contract, are assured:
'(a)
The material, component, or equipment is properly iden-tified, references any applicable codet, standards and
, specifications and corresponds with the identification on receiving documentation.
(b)
Material, components, equipment, and acceptance records are inspected and acceptable in accordance with QA inspection instructions, prior to use.
(c)
Inspection records and/or certificates of conformance attesting to acceptance of material and components are available prior to use. Audits and/or inspection over-checks are performed by Gregory Enterprises, Inc. QA personnel to assure the validity of supplier documenta-tion.
(d)
All documentation pertaining to deviations from pro-curement requirements including Non Conformance Reports (NCR) have been completed in accordance with their disposition.
Please also see Criterion 15, "Non-conforming Material, Parts or Components".
l (e)
Items accepted and released are identified by inspec-tion status prior. to forwarding to controlled storage areas or further work.
Source inspection is performed on those items where verification f
of procurement requirements cannot be determined upon receipt.
All describeC activities are delineated in approved Gregory Enterprises, Inc QA proceiures.
)
Criterion L.
IAgntification and Control 91 Material h Parts, And l
Components The identification and control of materials, parts, components and completed and in-process assemblies is administered by the QA Department in accordance with approved Gregory Enterprises, Inc.
QAL Procedures.
These procedures address quolity status tags, maintenance of material identification and traceability, part identification, and related documentation.
Some of the details of these procedures follow:
1
q "SCRI 10 CFR 71',1 SUBPART E, QA-PROGRAN' PG 13 OF 27 I
X' I
- 3
'(a) ! Material identification procedures included in QA in-spection planning and fabrication drawings require that
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identification of material, components, and/or hardware f
be maintained on tho-item or in traceable records to
^
prevent use of' incorrect-or defective items.
.p
,A (b) 'When:specified in safety related contractual or regula-tory criteria such as, topical and/or safety analysis
. reports,. QA personnel assure that identification of materials, components and equipment is verified via-oN
' alloy: overchecks, supplier audits-w a independent inspections as appropriate.
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.(c)
Specifications, procurement' documentation, fabrication t
o and inspection records, discrepancy reports, and mater-ial tastt. data are also periodically audited to assure
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c M itued, adherence to design, regulatory and, contract-u h '. requiremente.
1 (d)
Identification ravairements. such as engraving, stamp-i ing, stencil, character size, etc., are specified on l
design and fabrication drawings and reviewed by QA personnel. The reviews assure adherence to design, regulatory and contractual requirements for legibility, durability.and information content. Identification requirements and their implementation into fabrication l
. documentation also address traceability to contract and work order numbers and related project specifications via a series of prefix / suffix. identifiers.
. Require-i:
ments' are. delineated-in written procedures and are I
li
- utilized during Gregory Enterprises,- Inc. QA reviews to
- assure adherence.
t (e)
QA personnel assure, via drawings and QA: inspection planning. requirements, that identification locations'do y
not affect' the fitment, interfacing capability, perfor-E mance or overall quality of the product.. 'Identifica :
tion, in accordance with drawings and quality inspec-tion. planning requirements, is verified prior..to re-leasing the item for further processing or delivery.
?
criterion h control gi speelal Processes n
. Gregory Enterprises, Inc. approved QA Procedures delineate the-policies.and-procedures for. control of such special processes as:
b, welding, heat treating, Non-Destructive Examination (NDE),
.j painting, etc.
in accordance with applicable codes, standards, g
specifications, 10 CFR 71, Subpart H criteria and other require-ments.
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4EI 10 CFR 71, SUBPART H, QA VRO2 RAM PG 14'OF 27 t
Special processes developed by Gregory Enterprises, Inc. and its suppliers are documented, reviewed and approved by QA and other cognizant Gregory. Enterprises, Inc. personnel and/or regulatory and customer organizations.
In addition, special process equipment is identified, inspected and performance tested prior to use.
All procedures for special processes and the personnel required t
to perform them are qualified under the cognizance of the QA Department in accordance with applicable codes, standards, speci-f fications and contract requirements.
' They'are also subjected to full review and approval cycles and
. sequences as delineated in Criterion 6,
" Document Control "
by personnel qualified and approved by the QA Manager for the sub-ject matter of the special process.
Qualification records and support data are retained in the QA Data tile, and maintained in a current status by QA personnel.
These ' documents are. controlled as delineated in Criterion 6,
" Document Control", of this QA System description.
QA Inspection Planning prepared as described in Criterion 5,
" Instructions, Procedures and Drawings" and utilized in accord-ance with Criterion 10, " Inspection include requirements for witnessing of special processes when applicable and practical or verification via data review after the fact when appropriate.
This assures that special processes are performed by qualified personnel using qualified equipment in accordance with written-process sheets (or equivalent) with recorded evidence of witness-or verification.
criterion & Insnection All receiving, source, in-process, in-service, test and/or ship-ping inspection activities are performed in accordance with ap-proved Gregory Enterprises, Inc. QA procedures.
All inspection personnel and/or organization-qualifications are reviewed and accepted by the QA Manager prior to inspection activity.
-The inspection activity is performed in strict accordance with ap-proved QA Inspection Planning prepared by qualified QA personnel.
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ChIL 10 CFR 71', SUBPART H, QA PROGRAM -
pG 15 OF 27-
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f i'
please also see Criterion 5,
" Instructions, Procedures and Drawings".
Gregory Enterprises, Inc. QA personnel are independent from all
{;*
other organizations and report directly to the QA Manager.
QA Inspection personnel qualifications are based on their cap-ability to perform the required inspection functions in accord-ance with applicable codes, standards, professional society pro-s grama such as the ASQC quality technician certification, AWS QC1, SNT-TC-1A and Gregory Enterprises, Inc.
training
- programs, u
Qualification reviews are performed periodically to maintain personnel proficiency and assure current qualification.
Mandatory inspection hold points, inspection equipment require-ments, accept-reject criteria, personnel requirements, character-(.
istics to inspect, variables / attributes recording instructions, L
reference documentation and other requirements are included in r
the QA Inspection Planning.
The QA Inspection Planning, when completed, also includes results 6..
and supporting information such as variables and attributes data,
=
test results, - NDE records, welding information, certified ma-terial test reports and/or certifications, special process. data, discrepancy reports and related MRB dispositions and resultant re-inspection data, etc.
Enforcement of mandatory inspection hold points assures that in-process work does not proceed beyond the point where it can be properly inspected or verified.
They also prevent' unsatisfactory in-process work quality by specifying hold point buyof f. by QA personnel before further processing.
The QA Department assures that any replacements, modifications, or repairs' performed after final acceptance of material, compo-nents or hardware are incpected in accordance with the original or new QA Inspection Planning as appropriate.
Criterion & Ig_gt Control Test control', as-it applies to quality, is addressed in approved Gregory Enterprises, Inc. QA Procedures. It is assured, via QA Inspection Planning, that all required testing, such as proof and acceptance tests, are identified and performed in accordance with
' test procedures, design requirements, and limitations.
Pre-requisites, accept / reject and data recording criteria, instrumen-
.tation calibration, environmental conditions, documentation and evaluation requirements, etc. are delineated in the test pro-cedures.
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$3I 10 CFR 71, SUBPART: H, QA PROGRAM PG~16 OF 27
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Gregory Enterprises, Inc. QA' personnel assure, during test pro-cedure reviews prior to release, that, whenever practical, the normal and ' ant:.cipated off-normal operational performance de-scribed in applicable design, regulatory and contractual docu-ments are re-created during the testing activity.
Changes to test procedures are required to be rt2 Viewed / approved by the same organization (s) in the same cycle and sequence as the original issue.
Whenever equipment, components, and/or assemblies require modifi-cation, repairs, or replacement which could result in require-ments for re-test or additional testing, QA personnel assure that original or new test QA Inspection Planning documentation is prepared and adhered to as appropriate.
Test results are documented, evaluated and accepted by qualified personnel as required by the test QA Inspection Planning prepared for the test under the cognizance of QA personnel.
Criterion & Control 21 Measurina gns Testing Ecruinment Administration of measuring equipment and instrumentation cali-bration is. performed by the QA Department. in accordance. With approved Gregory Enterprises, Inc. QA Procedures.
The calibra-tion. system assures that all standard measuring instruments (SMI) requiring calibration ufor use in the acceptance of material, equipment, and assemblies are calibrated and properly adjusted'at specified intervals to maintain accuracy within pre-determined-limits.
Calibration is performed using equipment traceable o to national standards.-
Calibrated equipment'is identified and is traceable to the calib-ration test data.
Identification includes the equipment Property-
. Number, next calibration due date and~ inspector's or' calibrator's 1 stamp attesting to the accuracy and validity of the calibration.
. Calibration accuracy is maintained by utilizing standards trace-able to the National Institute of Standards and Technology (Formally National ' Bureau of Standards) that have an accuracy that is at least four (4) times grep er than the~ equipment being calibrated unless' limited by the sthce-of-the-art.
L Whenever SMI are found to be out of calibration during or immed-
'iately after use, ; all items inspected during that period are rejected by inspection and are submitted to. review action for possible re-inspection or other appropriate corrective action.
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CEI 10 CFR 71, SUBPART N, QA PROGRAM PG 17 OF 2 7 -
p i p:
y These reviews are performed by the MRB in accordance with criterion 15, "Non-conforming Material, Parts or Components".
. Criterion & BAngline, storace, And shipp.ing Gregory Enterprises, Inc.
approved QA Procedures require that handling, storage, and shipping requirements adherence verifica-tion criteria be included in QA inspection planning.
t These requirements are designed to prevent damage or deteriora-tion of-material and equipment and violation of applicable regu-y latory criteria.
Information pertaining to shelf life, environment control re-quirements, packaging, cleaning, handling,-preservation, testing, etc.,
is included as required to meet design and regulatory
~
shipoing, handling and storage requirements as appropriate.
1, Shipping-documentation preparation, departure, and arrival time and destination data recording-is also addressed in-the QA Inspection Planning, when applicable.
The requirements in QA Inspection Planning pertaining to shipping must be met prior toi release.for shipment.'
criterion & Insnection. Test and Operatina Status The use of-inspection status tags, quality inspection stamps, and other. means.to' indicate inspection and test status at, or for, Gregory Enterprises, - Inc. are > delineated. in approved QA Pro- '
4 cedures.
The clarity of the status indication, prevention of inspection,
.and/or test step by-passing, and prohibition:of removal or modi-
'fication :. of status jndications, except.with Quality Assurance' l
Department approval.andi Material-Review ' disposition' is assured.
Via these ' procedures.
The QA Department assures.via Quality Procedure, interoffice memoranda, training sessions, and. audit -
that. all Gregory. Enterprises, Inc. personnel are aware of and
' understand the-meaning and uses of status tags on all' hardware, material, and test setups,
- m.,
Please also see also Criterion 15, -"Non-Conforming Materials, l
l
Parts or Components".
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n l6EI?101CFR 71,:BUBPART N, QA PROGRAM PG 18'OF 27' criterion AL; Mon-conformina Material. Part.a 9I Componentt Gregory Enterprises, Inc. approved QA Procedures require that material, components, equipment and processes that do not conform to requiremer.ts are controlled to prevent their inadverte ;c use.
l Identification, segregation, discrepancy reporting, ditposition of non-conformances by authorized individuals and re-i ispection
-activities are performed and controlled in strict accordince with these procedures.
4 Non Conformance Reports (NCR) are utilized by the Gregt ry Enter-prises, Inc. QA Department and Gregory Enterprises, Inc.- sup-pliers -. to identify discrepant items, describe - the d.i:cawpancy, provide disposition and re-inspection requirements.
the signa-
_{
turesi of, authorized cognizant personnel are placed on the NCR to i
signify approva11of the disposition.
1 i
These authorized personnel are members of the Material Review l
Board (MRB), from Procurement and/or Production,- Program Manage-ment,. Mcument Control and Quality Assurance. The customer and/or I
lregulat.or is included when specified by contract and/or regulation.
The MRB.has been established to disposition all discrepancies or 1
disagreements pertaining to the acceptability of material, hard-J ware,_ processes -or operations, both within Gregory Enterprises, Inc. and ' at it's suppliers.
Their dispositions are final ~ and binding.-
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All MRBupersonnel must be approved by_the QA Manager and Presi-dent and must be from the same. groups approving the original design.
'QA assures that all " accept-as-is" or " repair" dispositions in-1 clude technical - justification that indicates and assures con-tinued compliance with all design, regulatory and contractual-
. i requirements.
' Copies of all such dispositions are forwarded by Gregory Enterprises, Inc. QA to the equipment owner or user as required by contractual and regulctory criteria.
In conjunction with repair or re-work dispositions, : QA' personnel provide supplemental inspection planning to verify proper imple-j
-mentation of the MRB disposition.
This assures that the item is re-tested and/or re-inspected to a degree at least equal to the original. acceptance activity.
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L CEI' 10 ; cFR 71~,: SUB ART H, QA PROGRAM PG 19 OF 27
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criterion ig_,, corrective Action Failures,. malfunctions, and deficiencies in material, components,.
equipment and services are identified and reported to the QA Manager and the President.
The cause of the condition and cor-
- rective action necessary to prevent-recurrence is identified, implemented and followed up to verify corrective action. effec-tiveness.
in analysis of d sct.Xcncies is conducted on a continuous basis.
This analysis establishes quality trends and2 pinpoints problem j
areas for corrective action.
Trends within Gregory Enterprises, Inc. and at suppliers are identified and evaluated.
-.The. analysis, quality trends and related reports are prepared by the Gregory Enterprises, Inc. QA Manager and presented to the Gregory Enterprises, Inc. President for review, information and action as the President deems appropriate.
An annual-Quality Trend analysis and summary is also issued to the President.
i.
Detail requirements for this activity are delineated in approved Gregory Enterprises, Inc. QA Procedures.
.QIlterion 12., Quality Assurance Records The QA Records system at Gregory Enterprises, Inc.
is admin-istered in'accordance with approved Gregory Enterprises,-Inc. QA
. procedures.-
The purpose of the QA Record ' system 'is to assure that documented evidence pertaining to: quality related activities is maintained and available for use by Gregory Enterprises,'Inc.,
its customere, and/or regulatory - agencies as applicable.
QA l
Records iinclude, but are - not limited to, inspection and test
_l records, audit reports, quality personnel qualifications,. quality 1
- e
-related procurement data, supplier evaluation reports, etc.
All l
records ; are identified by - work : order number, part number, con-1 l
(tract ' number, or drawing number as appropriate to the record p
type.'
A complete. list of all QA records is maintained and provides l-
' cross reference.between the different identity methods described l
above and pinpoints the record location.
Design, adherence - documentation an' records such as fabrication o
l>
drawings, inspection records, et are retained in the QA Re-cords. system for the life of the applicable' product.
All' other-
.I H
QA'related' records are retained for a minimum of two years, but
)
it no more than five years unless otherwise specified by applicable regulatory, code, standard or contractual requirements.
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L EI,10 CFR 71,-SUBPART N, QA PROGRANL PG 20 OF.27 x
' Inspection records ' retained in the QA Records system provide the
,. jfollowing data when applicable:'
(a)
Inspection type, i.e.,-in-process, in-service, testing, receiving, and shipping.
(b)
Evidence of completion and verification of manufactur-r ing, inspection, or test' operation.
(c)
The date and results of the inspection or test.
i (d)
Information related to noted discrepancies.
3 (e)
Inspector or data recorder identification.
I s
(f)
Evidence of acceptance.
l All QA records are retained in duplicated, separate and equal
{
storage with access control, fire, flood, deterioration and theft
't l'
protection.
,j criterion 132 Audits 1
' MANAGEMENT AUDITS IInternal _ QA Program audits 'are performed annually ' by personnel s
!not "under the full 1 time employ of Gregory Enterprises, Inc.' and
.7 without_ direct responsibilities in the areas being' audited, j
These: audits provide' comprehensive =, independent verification 1and.
4 evaluation of the implementation of the entire 10 CFR 71',- Subpart-H Gregory Enterprises,:Inc. QA System'.
(q l
= Written planning sheets'and check lists prepared by the auditor are utilized.
At audit completion,1the: Gregory Enterprises, Inc.
'QA' Manager evaluates the planning and check lists to verify that the ' audit addressed-all' facets of the Gregory ' Enterprises, Inc.
QA system.
Audit: results and corrective action activity are reported to the Gregory Enterprises, Inc. QA Manager 'and President, in writing ~,
and are retained in the QA record file.
Responsible management personnel are required to; respond to audit findings with the necessary action to correct the noted deficiencies.
' Areas found. deficient during these audits are re-audited on a first priority basis to verify corrective action implementation and: effectiveness.
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,GEI>10 CFR 71, SUBPART N, QA'. PROGRAM PG 21 OPS 27
,y-v 4
INTERNAL AUDITS The Gregory-Enterprises, Inc. QA Manager conducts audits of all quality related functions within Gregory Enterprises, Inc.'on a i
continuous' basis.
These audits are performed to assure continued
- adherence to the 18 criteria of.10 CFR 71, Subpart H and the Gregory Enterprises, Inc. QA program. These ' programmatic audits quickly identify and assure correction of any. deviations.from the
~
Gregory. Enterprises, Inc.
QA system during its actual utilization.
Written. audit check. lists are utilized to record the results of the audits. The Gregory Enterprises, Inc. QA Manager reviews the written-audit results with management personnel responsible for the activity being audited.
Any required corrective actions are agreed to between responsible management personnel and the QA Manager and implemented as.appro -
priate. The agreed -to corrective actions are reviewed during future internal audits to verify corrective action implementation and effectiveness.
The complete -Gregory Enterprises, Inc.
QA program and the applicable 18 criteria are audited annually in this manner.
' EXTERNAL AUDITS Gregory Enterprises, Inc. QA - auditors perform annual audits of l:
ac:
e suppliers to assure continued adherence. to. Gregory El.ce 4 rises,
-Inc.
imposed des,',gn, procurement
.and QA requirements.
Written l audit checklists are utilized during all supplier audits conducted by L the: Gregory Enterprises, Inc. QA auditors.
- Written. audit results are - reviewed with the affected supplier.
Mutually: acceptable corrective Actions are established as appli-cable.- Any required corrective action implementation and effec-tiveness is evaluated by Gregory Enterprises, Inc. QA personnel i
as part of. the supplier's continued approval status review via subsequent audits and inspections, j
q GENERAL L
L Gregory Enterprises, Inc. and contract audit personnel are certified!QA Lead Auditors, with applicable experience and j
expertise, who have met the requirements of ANSI N45.2.23.
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CEI 10 CFR 71,ESUBPART E,;QA PROGRAM PG 22'OF 27 1
i During-Internal-and External. audits, other Gregory Enterprises, j
Inc.-;or contract personnel are utilized-to supplemen' the'aud-itors, when required, to provide direct. expertise in specific fareas of.the~ audit. This-assures that the technical adequacies ol' 1
=the areas being' audited are properly addressed. The selection of supplemental audit personnel is the responsibility of the Gregory-
-Enterprises,- Inc. QA Manager and the cognizant' Department Manager.
All ' audits are scheduled to assure timely performance. prior to j
the need for the particular external or internal function.
.Need is-established via projections of upcoming contracts, procurement,- fabrication, inspection and/or testing phases of existing contracts.
i Problem areas established by Quality Trend Analysis reports and l
previous audits-are also-utilized to establish future' audit priorities.
'To assure objectivity, final audit reports and-corrective action I
agreements from both internal-and external-audits are E initially -
analyzed by-the Gregory Enterprises, Inc. QA Manager. _After this.
preliminary = review, cognizant Gregory Enterprises, Inc.
management personnel from the. activity affected by-the audit are i
consulted for input and response to the audit findings and agreed to: corrective actions.
Corrective' action may include, but not be limited to: personnel evaluation and training, procedural re-evaluation,- changes 'or enforcement, facility re-design,.
etc.
Please also'see Criterion 16, " Corrective Action"'.
i
.After completion of these steps, all : audit y asults and agreed to i
, corrective actions, Audit Trend Analysis. reports-delineating j
l Quality Trends and QA Program Effectiveness and any additional:
l inputiresulting from the~ post audit' review are forwardedi to the l-Gregory Enterprises, Inc. Presidenu..
'The President reviews the j
[,
complete audit and supporting data-for information and any.
~ dditional action as appropriate.
a References l
l,
.:(1) 10 CFR 71, Subpart H,
Criteria 1-18:
" Quality Assurance l
^
Criteria for' Shipping Packages for Radioactive Material".
(2)
Gregory Enterprises, Inc. Quality Assurance Manual t
GEI.10 CFRL 71sf SUBPART H[ QA PROGRAM.
PG 23-OF 37 1
i u
Attachments Figure 1:
" Quality Requirements Matrix - 10 CFR 71, Subpart'H,.
i Criteria.: 1-18 vs. Gregory Enterprises, Inc. Quality i#
Policy Numbers 1 through 16".
Figure' 2A: Gregory Faterprises, Inc.: General Functional.Organi-zation Chart, Dated June 11, 1990.
Figure 2B:
Gregory Enterprises, Inc.: QA Department Functional Organizational Chart, Dated June 11, 1990.
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EEI 10 CFR 711 SUBPART H,. QA PROGRAM PG=24 OF:27 l
l
-FIGURE 1:
OUALITY ASSURANCE MATRIX: la CEB E gel QA POLICIES 10 CFR.71,-SUBPART H l
GEI QA POLICY ~
I.
ORGANIZATION QP MANUAL, PG 1: QUALITY PROGRAM QP 1: QUALITY ORGANIZATION II.-
QUALITY ASSURANCE PROGRAM QP 2: QUALITY MANUAL CONTROL QP 14: QUALITY TRAINING III.
DESIGN-CONTROL QP 5: -DESIGN _ REVIEW AND CONTROL IV.
PROCUREMENT' DOCUMENT CONTROL QP 4 : PURCHASING CONTROL' j
V.
INSTRUCTIONS, PROCEDURES &
QP 3: DOCUMENT CONTROL DRAWINGS QP 6: QUALITY PLANNING
}
I.
VI.
DOCUMENT CONTROL QP 3: DOCUMENT CONTROL
-j VII.- -CONTROL OF PURCHASED.
QP 4 : PURCHASING CONTROL' l
MATERIAL, EQUIPMENT &
QP 8 : MATERIAL CONTROL SERVICES j
1
,VIII.-IDENTIFICATION & CONTROL-QP 3: DOCUMENT CONTROL OF MATERIALS, PARTS &
QP 8: MATERIAL CONTROL
-.l COMPONENTS
-t
'IX.
ECONTROL OF SPECIAL' PROCESSES QP 4: PURCHASING CONTROL
'QP'6:1 QUALITY PLANNING QP-7: INSPECTION & VERIFICATION QP 9: SPECIAL PROCESS CONTROL-o l<.
INSPECTION QP 7: INSPECTION & VERIFICATION-j
-1 l.
i
FIGURE 1 (CONTINUED):
10 CFR 71, SUBPART H l GEI QA POLICY XI.,
TEST CONTROL.
QP 6: QUALITY PLANNING l
QP */: INSPECTION & VERIFICATION XII.
CONTROL'OF MEASURING QP 11: CALIBRATION CONTROL-
&. TEST EQUIPMENT l
~
4 XIII. HANDLING, STORAGE QP 6: QUALITY' PLANNING'
& SHIPPING QP 7: INSPECTION & VERIFICATION QP 8: MATERIAL CONTROL j
XIV.
INSPECTION, TEST &
QP 7: INSPECTION & VERIFICATION OPERATING STATUS XV.
NONCONFORMING MATERIALS QP 10:' DISCREPANCY REPORTING i
PARTS OR COMPONENTS I
.XVI.
CORRECTIVE ACTION QP 16: CORRECTIVE' ACTION i
I XVII..QA RECORDS-QP-2: QUALITY MANUAL' CONTROL QP 12:-QUALITY RECORDS QP 13: FORM CONTROL 1
-XVIII. AUDITS QP 15: AUDITS I
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!CEI.-;10fCFR 71, SUEPART N, QA PRO RAN
'PG 26 OFJ27 io1
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FIGURE?2At:
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f GEIt GENERAL' FUNCTIONAL ORGANI5ATION CHART, DATED JUNE 11, 1990.
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PRESIDENT
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t VICE-PRESIDENT
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-QA/QC
.PURCHA8ING
.I P
MANAGER _
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. PRODUCTION SEE FIGURE
- 2B FOR QA/QC
- ORGANISATION
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8 ALES
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.'N OFFICE MANAGER' 7;
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' ' CEI:l 10_ CFR 71, SUBPART N, QA' PROGRAM.
PG 27 OF 27
, io ll ni J-FIGURE 2Bt c
. GEI [ QA DEPARTMENT = FUNCTIONAL ORGANIZATION CHART JUNE.11, 1990.
s II QA/QC MANAGER
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INSPECTION
. QUALITY ENG.
QUALITY AUDIT' i
RECEIVING PROCESS QA'
' INTERNAL
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1 IN-PROCESS DOCUMENT EETERNAL QA A
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TESTING.
PROCUREMENT
'gi QA-FINAL QA RECORDS u
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n SHIPPING 1
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