ML20029A129
| ML20029A129 | |
| Person / Time | |
|---|---|
| Site: | 07100702 |
| Issue date: | 01/25/1991 |
| From: | Gregory L JACOBS ENGINEERING GROUP, INC. |
| To: | |
| Shared Package | |
| ML20029A127 | List: |
| References | |
| GEIQA-01-90, GEIQA-1-90, NUDOCS 9102040182 | |
| Download: ML20029A129 (28) | |
Text
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' ' CNI 10 CFR 71, SUBPART H, QA PROGRAM PG 1 OF 28 10.CFR 71, SUBPART H QUALITY ASSURANCE PROGRAM FOR FABRICATION OF SHIELDED TRANSPORTATION CONTAINERS d
i LETTER NUMBER GEIQA-01-90 REVISION 1 JANUARY 11, 1990 s
Grspory Enterprisee, Inc.
Hobbs Highway Box 2308
+
Carlsbad, NM 88220
-APPROVALS REVISION ll-PRESIDENT /DATE l
QA MANAGER /DATE-fQ3/-A5-Y/
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CEI 10 CFR 71 SUCPART H, QA PROGRAM PG 2 OF 28 i
INIRQDUCTION Gregory Enterprises, Inc. has developed a Quality Assurance Sys-I 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 Instructions) necessary to exercise cont ~ol over documentation, procurement,
- material, fabrication, ir spection, and Quality data retention.
Please also see Criterion 2,
" Quality Assurance Program" for Quality Manual Discussion.
Gregory Enterprises, Inc.'s QA System and implementing Quality Procedures (QP) are designed and administered to meet the requirements of.10 CFR 71, Subpart H.
t 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 Q.t.1 te ri on L. QI.gani z ation -
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 Gregory Enterprises, Inc. QA approved suppliers. These include calibration of measuring equipment. NDE and materials testing.
Gregory Enterprises Inc. surveys and qualifies.all organizations performing these services to assure adhorence to the 18 criteria prior to their use. However, the responsibility of the control of QA i n tho other organizations continues to rest with Gregory _
Enterprises, Inc..
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 Gregory Enterprises, Inc. QA directed and approved personnel.
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CEI 10 CFR-71, SUBPART H, QA PROGRAM PG 3 OF 28 L
Gregory Enterprises, Inc.'s President has full authority over all functions of the c>mpany, and delegates authority and 4
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 perform-ance 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-pliars appear on the Gregory Enterprises, Inc Approved Suppliers List (ASL) as being so qualified.
The Gregory Enterprises, Inc. QA Department has complete 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 President of Gregory Enterprises, Inc..
The QA Department? is headed by the QA Manager who is responsible for the. development, implementation and administration of the total Gregory Enterprises, Inc. QA Program and all related act-ivities' and functions.
The QA Manager must have sufficient ex-pertise in the entire field of Quality to enable him to direct the entire QA function in close adherence to the 18 criteria and the Gregory Enterprises, Inc QA Manual.
- REV 1 The QA Manager is required to meet the following general qualifi-cation criteria as a minimum:
1.
A-B.S. or B.A. degree in a technical field.
AND:
A total of five (5) years of experience directly related to QA functions in regulated NRC, DOE, ASME B & P Code, Military or NASA regulated industry.
l
CEI 10 CFR 71, BUBPART H, QA PROGRAM PG 4 OF 28 OR:
1.
A total of ten (10) years of experience directly related to QA functions in regulated NRC, DOE, ASME B & P Code, Military or NASA regulated industry.
4 AND:
A current ASOC QE certificate.
OR:
A current Professional Engineer's license in_ Mechanical, Nuclear or Quality Engineering from any State.
The QA Program and supporting QA Manual and procedures developed 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.
Responsibility. for development of QA acceptance requirements, inspections, and NDE activities rost with the QA Manager. It is also his responsibility to delegate and ', valuate the performance of all QA related tasks for Gregory Enterprises, Inc. through the authority of the President.
In written di?ectives, the QA Hanager designates GEI personnel with authority to perform QA functions that prevent the continued processing, fabrication, installation or delivery of unsatis-factory work.
- QA authority ~also extends to-the monitoring of special processes utilizing Gregory Enterprises, Inc, equipment, personnel and procedures such as testing, field erection, welding,. machining processes, painting, etc.
Production responsibilities include scheduling of inspection and administration of all fabrication activities, both within Gregory Enterprises. Inc. and at qualified suppliers.
The shipping and receiving function is also the responsibility of personnel cognizant of the production activity but is performed through the Procurement activity.
On-site activities such as-field inspections, field testing pro-grams, field welding, etc. are administered as a joint effort of the QA/QC and Production personnel of Gregory Enterprises, Inc.
and QA approved contractors as required.
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CEI 10 CFR 71, SL'.' DART H CA PROORAM.
PG 5 OF 28 The Gregory Enterprises, Inc. QA Department supports these activ-ities with written procedures that provide methods, process con-trels and check points.
Inspection personnel perform monitoring activities and verifications of regulatory, contractual and tech-nical requirements during these operations.
l 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.
L
- REV 1 Personnel performing inspections and verifications to assure conformance to QA requirements are independent from the organiza-tions performing the fabrication and assembly of Gregory Enter-prises, Inc, products.
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. Figures 2A and 2B-provide general Gregory Enterprises, Inc.
Organization Charts for the company and the QA function in par-ticular.
Criterion 2r Ryality Assurance Program Gregory Enterprises, Inc. has established and implemented a QA Program for the control of quality in the fabrication of shielded transportation containers for nuclear products. The QA Program is documented in the Gregory Enterprises, Inc. QA manual.
- The QA Manual is comprised.of two separate but interrelated documents as follows:
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. overview of what QA is to the company, and who has the' responsibilities for it.
It is informative and concise.
The basic 18 criteria of 10 CFR 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 =
and suppliers.
The QPs provide a standard reference for QA that all person-nel and suppliers receive and refer to for basic-information on the Gregory Enterprises.-Inc. QA process.
This enables all personnel and suppliers to grasp the intent of'the Gregory Enterprisas, Inc. QA System and become part of the QA program. This allows everyone to become respon-sible for quality in their individual work.
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. ' ' - CEI 10 CFR 71, SUBPART H, CA PROGRAM PG 6 0F 28 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-tion and control (such as welding, NDE and painting), ma-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 demands.
The QI System iL designed to allow revision without disrup-tion of the Basic Quality Policies of Gregory Enterprises, Inc.
Quality of documentation, procurement, product, services and the reputation of Gregory Enterprises, Inc. is the responsibility of every employee.
Orientation of each employee emphasizes this fact.
All personnel in the company are provided with, or have direct access to, controlled copies of the QA 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.
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 Hanager.
These procedures require that qualification and training status records be retained in the QA Personnel record file under the control of the QA Hanager.
This requirement pertains to all Gregory Enterprises, Inc personnel and Gregory Enterprises, Inc.
supplier and contract personnel involved in QA related activities.
REV 1 General and specific training and indoctrination requirements are delineated, in writing, to each individual requiring QA related training.
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CEI 10 CFR 71, SUBPART H, QA PROGRAM PG 7 OF 28 Qualification such as SNT-TC-1A for NDE disciplines, ASME Section IX or AWS Di.1 for welding and AWS 001 for welding Inspectors are obtained through classroom training, controlled on-the-job training and verifiable experience.
Other QA related Qualifications such as dimensional inspection, calibration methods. Inspection planning development and HRB participation are based on a variable mix of classroom training, on the job training, formal education, certification by recognized professional organizations such as the ASQC, AWS and ASNT and verifiable experience as applicable to the individual and their assigned QA activities.
The individual's training and indoctrination records are updated as the assigned training, orientation and 11doctrination activities are completed.
Qualification areas under the direct cognizance of QA shall include, but not be limited to:
1.
Quality Engineering.
2.
Inspection.
3.
Non-Destructive Examination (NDE).
4.
Auditing.
5.
Testing.
6.
Calibration.
7.
HRB.
Special process approval and maintenance of qualification records of personnel performing them shall be the responsibility of the QA.
Special processes shall include, but not be limited to:
1.
Welding.
2.
Heat Treating.
3.
Chemical or electro-deposited coatings.
4.
Painting.
Actual process and supporting procedure development, personnel training, testing and documentation shall be the responsibility of the special process supplier or cognizant organization.
However, the QA/QC Hanager assures their performance.
GEI 10 CFR 71, SUBPART H, QA PROGRAM PG 8 OF 28 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
]ll each individual.
The data is evaluated and updated annually.
Additional training, orientation and or schooling is specified by the QA Hanager when impending personnel assignment changes and/or contractual or regulatory applications juttify it.
- REV 1 Personnel who do not maintain the qualifications required to perform quality related activities specified in contractual, regulatory and/or Gregory Enterprises. Inc. requirements are directed to re-qualify.
As an option, they may be assigned to other activities where the specific qualification is not
- required, a
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-tics 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.
Use of this graved approach to QA system implementation assures proper QA systn Utilization on all activities.
r The President vi 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 System, including the QA Manual Policies and Procedures, be implemented and enforced on all applicable programs at Gregory Enterprises, Inc.
Please also see also Criterion 16, " Corrective Action".
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EEI 10 CFR 71, SUBPART H, QA PROGRAM PG 9 0F 28 1
All discrepancies in materials, hardware and/or processes occur-ring during fabrication activition are reported in writing and 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 for the dispositions. MRB dispositions are final and binding.
Please also see also Criterion 15, " Nonconforming Materials, Parts or Components" for further discussion about the MRB.
CritaElqo L DesiaD Control Gregory Enterprises, Inc. does not provide designs.
Therefore, this criterion is not specifically 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.
- REV 1 Design and fabrication drawings for licensed equipment provided by Gregory Enterprises, Inc. customers are compared to the requirements and acceptance criteria of the applicable C of C or license to assure adherence prior to use in fabrication.
There-after, the applicable design control documentation is utilized to assure adherence to the C of C or license during fabrication, inspection and acceptance.
Please see Criterion 6,
" Document Control" for discussion on control of design documentation suc' as specifications, pro-cedures and drawings.
Cr_ite_f.120 L Procurement D2pyment Control The Gregory Enterprises, Inc. QA Program assures that all 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 desigre documents, and source, in-process and receiving inspection are all administered and controlled in ac-cordance with approved Gregory Enterprises, Inc. QA procedures.
All procurement activity is-performed in accordance with written procedures delineating requirements for preparation, review, approval and -' control of procurement documentation.
Particular emphasis is placed on assuring that revisions to procurement documentation are reviewed and approved by the same cognizant groups as the original.
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l GEI 10 CFR 71, SUBPART H, QA PROGRAM PG 10 OF 28 The QA department checks procurement documents for complete re-view and approval by the cognizant personnel in accordance with written QA procedures pertaining to the procurement function prior to QA approval.
QA clause sheets are included with all request for quotes and purchase orders.
QA personnel assign clauses from the sheets to the procurement document referencing 10 CFR Part 71, Subpart H requirements appropriate to the contract.
Material informatiori 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-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.
Other documentation requirements and information such as draw-ings, procedures, material test data and certifications, inspec-tion and test requirements, hold points, wolding and other pro-cess qualification requirements and personnei qualifications are delineated, or verified to be present, en 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.
A statement to this effect is included on procurement documentation as appropriate to the contract.
The defect and noncompliance reporting requirements of 10 CFR 21.21 ara delineated in writing to all Gregory Enterprises, Inc.
supp1',ars a nd sub-contractors.
Criterior L Instructions. Proqqdures and Drawinas 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 procodures 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-nin0 as necessary to assure adherence to package design approvals and the applicable criteria of 10 CFR 71, Subpart H for the pro-duct being fabricated.
', CEI 10 CFR 71, SUBPART H, QA PROGRAM PG 11 OF 28 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 requirements, workmanship standards, and other related qualitative and quantitative data.
All instructions, procedures, and drawings are developed, re-viewed, approved, utilized and controlled in accordance with the requirements of written QA procedures.
Please also see Criterion 6,
" Document Contro1*.
Critorion L Ro_c.psnt p_ontrol 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.
Trancmittal sheets with receipt acknowledgment provisions are utilized to assure proper controlled document transmittal and receipt records maintenance for original issues and subsequent revisions.
Controlled documents include, but are not limited to:
(a)
Design manufacturing drawingr.
(b)
Fabrication drawings (c)
Special process specifications and procedures.
(d)
General procedures for activities in production, pro-curement, document control, training, etc.
(e)
(f)
QA Policies and Instructions.
(g)
All QA Inspection Planning.
(h)
Haterials data.
(i)
NDE data.
(j)
Source surveillance and evaluation reports.
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CEI 10 CFR 71. SUBPART H, CA PROGRAM PG 12 OF 28 l
(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, procodures, speci-fications, and purchase orders.
QA and Document Control Per sonnel 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.
CriLQIIDD L Control nf Perchap_qd Materialsi P_artu.and 9.omn9_t19_ tits 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 com ith the re-quirements of 10 CFR Part 71, Subps 4,
that are applicable to the contract. (Quality Asv ance)
(b)
A review of previous records and performance of th9 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.
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. CEI 10 CFR 71, SUBPART H CA PROGRAM PG 13 OF 28 Annual audits are conducted at active supplier's facilities dur-ing, but independent of, source inspection activities to assure
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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, ete'.
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.
l Please also see Criterion 5,
" Instructions.
Procedures and Drawings".
Receiving inspection is performed by Gregory Enterprises, Inc. QA personnel-to determine that the following, as appropriate to the contract,' are. assured:
'(a)- Th's material, component, or equipment is properly iden-tified, references any applicable codas, standards and i
specifications and corresponds with ths identification on-receiving documentation.
(b).,
Material,' components, equipment, and acceptance records q
are inspected and acceptable in accordance with QA j.
inspection instructions, prior to use.
(c)
Inspection records and/or certificates of conformance attesting to acceptance of material and comporants are available prior to use. Audits and/or inspection over-j.
checkt are performed by Gregory Enterprises. Inc. QA l:
personnel to assure the validity of supplier documenta-
- tion, i
(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".
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CEI 10 CFR 71 SUBPART H CA PROGRAM PG 14 OF 28 (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 of procurement requirements cannot be determined upon receipt.
All described activities are delineated in approved Gregory Enterprises, Inc. QA procedurcs.
ECILDI_iQU L
.ldRatif_lSAtioD And Q9atIQ1 Rf tiateria A Each And 99mRQneRLn The identification and control of materials, parts, components and completed and in-process assemblies is administered by the QA Department in accordance with approvsd Gregory Enterprises, Inc.
OA Procedures.
These procedures address quality status tags, maintenance of material identification and traceability, part identification, and related documentation.
Some of the details of these procedures follow:
(a)
Material identification procedures included in QA in-spection planning and fabrication drawings require that identification of material, components, and/or hardware be maintained on the item or in traceable roccrds to prevent use of incorrect or defective items.
(b)
When specified in safety related contractual or regula-tory criteria such as, topical and/or safety analysia reports, QA personnel assure that identification of materials, components and equipment is verified via alloy overchecks, supplier audits and independent inspections as appropriate.
(c)
Specificatior,s, procurement documentation, fabrication and inspection records, discrepancy reports, and mater-ial test data are also periodically audited to assure continued adherence to design, regulatory and contract-ual requirements.
(d)
Identification requirements such as engraving, stamp-ing, stencil, character size, etc.,
are specified on design and fabrication drawings and reviewed by QA personnel. The reviews assure adherence to design, regulatory and contrar;ual requirements for legibility, durability and information content.
Identification requirements and their implementation into fabrication documentation also address traceability to contract and work order numbers and related project specifications via a series of prefix / suffix identifiers.
Require-ments are delineated in written procedures and are utilized during Gregory Enterprises, Inc. QA reviews to assure adherence.
l CEI 10 CFR 71, SUBPART H CA PROGRAM PG 15 OF 28 (e)
QA personnel assure, via drawings and QA inspection planning requirements, that identification locations do not affect the fitment, interfacing capability, perfor-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.
C.titprion L C9ntro_1 af speeial P_ tac _ema Gregory Enterprises, Inc. approved QA Procedures delineate the policies and procedures for control of such special processes as:
welding, heat treating, Non-Destructive Examination (NDE),
painting, etc.
in accordance with applicable codes, standards, specifications, 10 CFR 71, Subpart H criteria and other require-ments.
Specia' 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 to perform them are qualified under the cognizance of the Qs.
Department in accordance with applicable codes, standards, speci*
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 end support data are retained in the QA Data file, 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.
- . GEI 10 CFR 71, SUBPART H, QA PROGRAM PG 16 OF 28 I
Cr_iterion 10_, Inaneetion 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 Hanager prior to inspection activity.
The inspection activity is performed in strict accordance with ap-proved QA Inspection Planning prepared by qualified QA personnel.
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-grams such as the ASOC quality technician certification, AWS QC1, SNT-TC-1A and Gregory Enterprises, Inc.
training programs.
Qualification reviews are performed periodically to maintain personnel proficiency and assure current qualification.
Mandatory inspection hold points, inspection equipment require-ments, accept-reject critaria, personnel requirements, character-istics to inspect, variables / attributes recording instructions, reference documentation and other requirements are included in the QA Inspection Planning.
The QA Inspection Planning, when completed, also includes results 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 HRB dispositions and resultant re-inspection data, etc.
Enforcement of mandatory inspection hold points assures that in-process work does not proceed beyond the point whera it can be properly inspected or verified.
They also prevent unsatisfactory in-process work quality by specifying hold point buyoff by QA personnel before further processing.
The QA Department assures that any replacements, modifications, or repai rs performed af ter final acceptance of material, compo-nents or hardware are inspected in accordance with the original or new QA Inspection Planning as appropriate, l
I GEI 10 CFR 71, SUBPART H, CA PROGRAM PG 17 OF-28 Criterion & Test Control
)
Test control, as it applies to quality, is addressed in approved Gregory Enterprices, 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.
Prerequi-sites, accept / reject and data recording criteria, instrumentation calibration, environmental conditions, documentation and evalua-tion requirements, etc. are delineated in the test procedures.
Gregory Enterprises, Inc. QA personnel assure, during test pro-cedure reviews prior to release, that, whenever practical, the normal and anticipated 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 reviewed / 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, priterion & Control of Measurina and Testing Equips nt 3
Administration of measuring equipment and instrumentation cali-bration is performed by the QA Department in accordance with approved Gregory Enterprises, Inc. QA Precedures.
The calibra-
-tion system assures that all standard measuring instruments (SHI)
. requiring calibration for use in the acceptance of material,
)
equipment, and ascemblies are calibrated and properly adjusted at specified intervals to maintain accuracy within pre-determined limits.
Calibration is performed using equipment traceable 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 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 greater than the equipment being p
calibrated unless limited by the state-of-the-art.
l -.
GEI 10 CFR 71, SUBPAR H. CA PROGRAM PG 18 0F 28 Whenever S4I are found to be out of calibration during or immed-intely 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.
These reviews are performed by the HRB in accordance with Criterion 15, *Non-conforming Material, Parts or Components".
CIM9fIp.D IL 114D1110R4 Et9BaR4 kus! SAIDAlu9 Gregory Enterprises, Inc.
approved QA Procedures require that handling, storage, and shipping requirements adherence verifica-tion criteria be included in QA inspection planning.
These requirements are designed to prevent damage or deteriora-tion of material and equipment and violation of applicable regu-latory criteria.
Information pertaining to shelf life, environment co.itrol re-quirements, packaging, cleaning, handling, preservation, testing, etc., is included as required to meet design and regulatory shipping, handling and storage requirements as appropriate.
- REV 1 The inspection planning is then utilized to perform periodic inspections of stored raw materials and/or finished product to verify continued adherence to configuration and condition criteria. Annotated and dated copies of the applicable inspection planning is retained to provide a permanent record of the material storage inspections, status and any corrections.
When specified by contractual and/or regulatory criteria, the documentation delivered with Gregory Enterprises, Inc. products includes operating manuals, maintenance manuals and related procedures necessary to utilize the product in accordance with applicable C of C or SARPs.
Shipping documentation preparation, departure, and arrival time and destination data recording is also addressed in the QA Inspection Planning, when applicable.
Tne requirements in QA Inspection Planning pertaining to shipping must be met prior to release for shipment.
Criterion Ib InnDft911Qux Ital And Operatino. 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-cedures.
1 GEI 10 CFR 71, SUBPART H, QA PROGRAM PG 19 OF 28 The clarity of the status indication, prevention of inspection, and/or. test step by-passing, and prohibition of removal or modi-fication of status indications, except with Quality Assurance Department approval and Material Review disposition is assured r
via these procedures.
The QA Department assures via Quality Procedure, interof fice 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.
Please also see also Criterion 15 "Non-Conforming Materials, Parts or Components",
priterion & Non-conformina Material Parts 2r Components a
Gregory Enterprises, Inc. approved QA Procedures require that material, components, equipment and processes that do not conform to requirements are controlled to prevent their inadvertent use.
Identification, segregation, discrepancy reporting, disposition of non-conformances by authorized individuals and re-inspection activities are performed and controlled in strict accordance with these procedures.
Non Conformance Reports (NCR) are utilized by the Gregory Enter-
- prises, Inc. QA Department and Gregory Enterprises, Inc. sup-pliers to identify discrepant items, describe the discrepancy, provide disposition and re-inspection requirements.
The signa-tures-of authorized cognizant personnel are placed on the NCR to signify approval of the disposition.
These authorized personnel are members of the Material Review Board-(MRB), from Procurement and/or Production, Program Manage-ment, Document Control and-Quality _ Assurance. The customer and/or regulator is included when specified by contract and/or regulation.
The MRB has been ostablished to disposition all discrepancies or disagreements pertaining to the acceptability of material, hard-ware, processes or operations, both within Gregory Enterprises, Inc. and at it's suppliers.
Their dispositions are final and binding.
All.MRB. personnel 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-clude technical justification that indicates and assures con-tinued compliance with all design, regulatory and contractual requirements.
Copies of all 'such dispositions are forwarded by Gregory Enterprises, Inc. QA to the equipment owner or user as required by contractual and regulatory criteria.
)
@EI 10 CFR:71, SUBPART M, @A PROGRAM PG 80 OF 28
~
- REV 1-In addition, all " accept-as-is" and "repai r" disposition are reviewed by_ the MRB for possible 10 CFR 21 reportability.
n.
In conjunction with repair or re-work dispositions, QA personnel provide supplemental i nspection planning to verify proper imple-mentation of the MRB disposition.
This assures that the item is re-tested and/or re-inspected to a degree at least equa; to the original acceptance activity.
CriterioD & porrective 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 i s i dentified, implemented and followed up to verify corrective action effec-tiveness.
An analysis of discrepancies is conducted on a continuous basis.
This _ analysis establishes quality trends and pinpoints problem 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 Hanager 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.
Detail requirements for_this activity are delineated i n approved Gregory. Enterprises,;Inc. QA Procedures.
Criterion & 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 customers, and/or> regulatory agencies as applicable.. QA Records include, but.are not limited to, inspection and test records', audit reports, quality-personnel qualifications, quality related procurement data, supplier evaluation reports, etc.
All records are identified by work order number, part number, con-
' tract number, or-drawing number as appropriate to the record type.
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'CEI 10 CFR 71, SUBPART H, CA PROGRAM PG 21 OF 28
- REV 1 Records are identified by the work order number and date and are cross referenced to the applicable contract number..The record
. identifier is utilized to retrieve records pertaining to specific products, production lots and contracts.
The records are maintained for the life of the product or for specific periods as delineated in applicable contracts and regulations.
A complete list of all QA records is maintained and provides cross reference between the different identity methods described above and pinpoints the record location.
Design adherence documentation and records such as fabrication drawings,. inspection records, etc., are retained in the QA Re-cords system for the life of the applicable product.
All other-QA related records are retained for a minimum of two years, but no more than five years unless otherwise specified by applicable regulatory, code, standard or contractual requirements.
Inspection records retained in the QA Records system provide the following data when applicable:
(a)
Inspection type, i.e.,
in-process, in-service, testing, receiving, and shipping.
(b)
Evidence of completion and verification of manuf actur-ing, inspection, or test operation.
(c)
The date and results of the inspection or test.
(d)
Information related to noted discrepancies.
(e)
Inspector or data recorder identification..
(f)
Evidence of acceptance.
All QA records-are retained in duplicated, separate and equal storage with access control, fire, flood, deterioration and theft protection.
- REV 1 Records-that are retained on temperature and light sensitive media, such as photographs, slides, negatives, radiographs, mag-netic tape or disks, etc., are retained in sealed containers in a temperature controlled environment.
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. CEI 10 CFR 71, SUBPART H, QA PROGRAM PG 22 OF 28
_CrJ191_ ion.lb Audi.ts l
HANAGEMENT AUDITS I
Internal QA Program audits are performed annually by personnel not under the full time employ of Gregory Enterprises, Inc. and without direct rest "1sibilities in the areas being audited.
- REV 1 The personnel -performing the audits are qualified Lead Auditors i
in accordance with ANEI N 45.2.23.
These audits provide comprehensive independent verification and evaluation of the implementation of the entire 10 CFR 71, Subpart H Gregory Enterprises, Inc. QA System.
Written planning sheets and check ' lists prepareri by the auditor are utilized.
At audit completion, the Gregory I,nterprises. Inc.
QA Hanager evaluates the planning and check lists to verify that the audit addressed all f acets of the Gregory Enterprises, Inc.
QA system,
- REV 1 Post audit meetings are held with the personnel cognizant in the area of any findings.
The results are reviewed and corrective actions are determined.
Audit results and corrective action activity are reported to the Gregory Enterprises, Inc. QA Hanager and President, in writing, and are-retained in the QA record file.
Responsible management personnel are rwquired 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.
INTERNAL AUDITS.
-The Gregory _ Enterprises, Inc. QA Hanager conducts audits - of all quality related functions within Gregory Enterprises, Inc. on a 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 dev1ations from the Gregory Enterprises, Inc.
QA system during its actual utilization.
'GEI 10 CFR 71, SUBPART H, Qt PROGRAM PG 23 OF 28 Written audit check list 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 offectiveness.
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 active suppliers to assure continued adherence to Gregory Enterprices.
Inc.
imposed
- design, procurement and QA requirements.
Written audit checklists are utilized during all supplier audits conducted by the Gregory Enterprises, Inc. QA auditors.
Written audit results are reviewed with the affected supplier.
Mutually acceptable Corrective Actions Sre established as appli-cable. Any required corrective action implementation and effec-tiveness is evaluated by Gregory Enterprises, Inc. QA personnel as part.of the supplier's continued approval status review via subsequent audits and inspections.
GENERAL Gregory Enterprises, Inc. and contract audit personnel are certified QA Lead Auditors, with applicable experience and expertise, who have met the requirements of ANSI N45.2.23.
During Internal and External audith, other Gregory Enterprises, Inc. or contract personnel are utilized to supplement the aud-itors, when required, to provide direct expertise in specific areas of the audit. This assures that the technical adequacies of 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 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.
5
'GEI 10 CFR 71, SUBPART H, QA PROGRAM PG 24 OF 28 Problem areas established by Quality Trend Analysis reoorts and previous audits are also utilized to establish future audit priorities.
To assure objectivity, final audit reports and corrective action agreements f rom both internal and external audits are initially analyzed by the Gregory Enterprices, Inc. QA Hanager.
After this preliminary review, cognizant Gregory Enterpt ises, Inc.
management personnel from the activity affected by the avoit are 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".
After completion of these steps, all audit results and agreed to corrective actions, Audit Trend Analysis reports delineating Quality Trends and QA Program Ef fectiveness and any additional input resulting from the post audit review are forwarded to the Gregory Enterprises, Inc. President.
The President reviews the complete audit and supporting data for information and any additional action as appi'opriate.
- -REV 1 All audits reports, including the monitoring of response dates and the adherence to them, are administered through the office of the QA Hanager.
ELuf.oreupan (1) 10 CFR 71, Subpart H.
Criteria 1-18:
" Quality Assurance Criteria for Shipping Packages for Radioactive Material".
(2)
Gregory Enterprises, Inc. Quality Assurance Manual Atlachments Figure 1:
" Quality Requirements Matrix - 10 CFR 71, Subpart H.
Criteria 1-18 vs. Gregory-Enterprises, Inc. Quality Policy Numbers 1 through 16".
Figure 2A: Gregory Enterprises, Inc.: General Functional Organi-zation Chart, Dated June 11, 1990.
Figure 28:
Gregory Enterprises, Inc.: QA Department Functional Organizational Chart, Dated June 11, 1990.
l..* ' *, C E I 10 CFR 7*..
SUBPART H, CA P3MRAM PG 25 OF 28 FIGURE 1:
QUALIlY MS_U.BA!LGE tdATR2X: 10 CEE YL G_El Q6 POLICIES 10 CFR 71, SUBPART H l
GEI QA JOLICY I.
ORGANIZATION Q) MANU\\L, PG 1: QUALITY PROGAAM QF ;: GUALITY ORGANIZATION II.
QUALITY ASSURANCE PROGRAM QP 2: QUALITY MANUAL CONTROL QP 14 : QUALITY TRAINING III.
DESIGN CONTROL QP 5: DE51GN REVIEW AND CONTROL IV.
PROCUREMENT DOCUMENT CONTROL QP 4: PURCHASING CONTROL V.
INSTRUCTIONS, PROCEDURES &
QP 3: DOCUMENT CONTROL DRAWINGS QP 6: OUALITY PLANNING i
VI.
DOCUMENT CONTROL QP 3: DOCUMENT CONTROL VII.
CONTROL OF PURCHASED QP 4: PURCHASING CONTROL MATERIAL, EQUIPMENT &
QP 8: MATERIAL CONTROL SERVICES VIII. IDENTIFICATION & CONTROL QP 3: DO;'JMENT CONTROL OF MATERIALS, PARTS &
QP 8: MATERIAL CONTROL COMPONENTS IX.
CONTROL OF SPECIAL PROCESSES QP 4: PURCHASING CONTROL QP 6: QUALITY PLANNING QP 7: INSPECTION & VERIFICATION QP 9: SPECIAL PROCESS CONTROL X.
INSPECTION QP 7: INSPECTION & VERIFICATION
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GEI 10 CFR 71, SUBPART R, CA PROQ: TAM FG 26 OF 28
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10 CFR 71, SUBPART H l GEI QA POLICY XI.
TEST CONTROL QP 6: Qd4LITY PLANNING I
QP 7: INSPECTION & VERIF/ CATION XII.
CONTROL OF MEASURING QP 11: CALIBRATION CONTROL
& TEST-EQUIPMENT XIII. HANDLING, STORAGE-QP 6: QUALITY PLANNING
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& SHIPPING QP 7: INSPECTION & VERIFICATION i
QP 8: MATERIAL CONTROL XIV.
INSPECTION, TEST &
QP 7: INSPECTION & VERIFICATION OPERATING STATUS XV.
NONCONFORMING MATERIALS QP 10: DISCREPANCY REPORTING i
PARTS OR COMPONENTS
-t XVI.- CONRECTIVE ACTION QP 16: CORRECTIVE ACTION XVII. QA RECORDS QP 2: QUALITY-MANUAL CONTROL QP 12: QUALITY' RECORDS QP 13: FORM CONTROL XVIII. AUDITS QP 15: AUDITS L
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8 GEI: GENERAL FUNCTIONAL ORGANIZATION CHART, DATED JUNE 11, 1990.
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FIGURE 28:
GEI: QA DEPARTMENT FUNCTIONAL ORGANIZATION CHART JUNE 11, 1990.
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