ML19211C403
| ML19211C403 | |
| Person / Time | |
|---|---|
| Site: | 07100122 |
| Issue date: | 11/15/1979 |
| From: | J.L. SHEPHERD & ASSOCIATES |
| To: | |
| Shared Package | |
| ML19211C398 | List: |
| References | |
| 14824, QA-RM-001-A-01, QA-RM-1-A-1, NUDOCS 8001110289 | |
| Download: ML19211C403 (51) | |
Text
7/_. 0 / 2.z a r2 Y k 1 1 0 ci a fE 1 I
f l
l 213/245-0187 740 Salem Street, Glendale. California 91203 Nuclear Applications Lead Sn:e: ding Irradiation & Calibration Equrpment e
OUALITY ASSUR ANCE PROCEDURES FOR DESIGN, FABRICATION AND USE OF SHIPPING CONTAINERS AND OVERPACKS USED FOR THE TRANSPOR TATION OF R ADIOACTIVE MATERIALS DOCUMENT TITLE: Number QA-RM -001-A
[
LICENSEE: J. L. Shepherd and Associates 740 Salem Str.cet Glendale, California 91203 (213) 745-0187 1735 241
.<s 8001110 2.81 y
A w,_2
' *4NUF ACrGnt HS ik. t L: '
CONSUlio. i:3
TABLE OF CONTENTS e(
R e vi s io n S h e e t................................................ 2 I n tr o du c ti o n....................................... '........... 3 I
I. Organization
- 1. S tate me nt o f R e s pons ibili ty............................... 4
- 2. Quali ty Pl aning M anu al................................... 5
- 3. O r g aniz a tio n C h a r t...................................... 16
- 4. J ob D e s c r ip u o ns........................................ 17
- 5. Job Description and Qualification - Head, Q. A. P rog ram.... 2 5
- 6. S ta te me nt o f R e s po ns ib ili ty............................... 2 6 II. Quality Assurance Program S ta te m e n t s 1 - 5........................................... 2 7 S ta te m e n ts 6 - 7........................................... 2 8 III. Design Control S ta te m e n ts 1 - 3........................................... 2 9 S ta te m e n ts 4 - 8........................................... 3 0 IV. Procurement Document Control S ta te m e n ts 1 - 5........................................... 3 1 S ta te m e n ts 6 - 7........................................... 3 2 r
E V. Instructions, Procedures and Drawings S ta t e m e n t s 1 - 3........................................... 3 3 VI. Document Control S ta te m e n ts 1 - 5.......................................... 3 4 VII. Control of Purchased Materials, Parts and Components S ta te m e n t s 1 - 5........................................... 3 5 S ta te m e n t 6............................................... 3 6 VIII. Identification and Control of Materials, Parts and Components S ta te m e n ts 1 - 5........................................... 3 7 IX. Control of Special Processes S ta te m e n ts 1 - 3....................... -.................... 3 8 X. Inspec tion S ta te m e n ts 1 - 5........................................... 3 9 XI. Test Control S ta te m e n ts 1 - 3........................................... 4 0 1735 242 f
~
TABLE OF CONTENTS (continued) r L
XII. Control of Measuring and Test Equipment S ta te m e n ts 1 - 4.......................................... 4 1 XIII. Handling, Storage and Shipping S ta te m e n ts 1 - 4.......................................... 4 2 XIV. Inspection, Tes t and Operating Status S ta te m e n ts 1 - 4.......................................... 4 4 XV. Nonconforming Materials S ta te m e nts 1 - 4.......................................... 4 5 XVI. Corrective Action S ta te m e n ts 1 - 3.......................................... 4 6 XVII. Quality Assurance Records S ta te m e n ts 1 - 6.......................................... 4 7 XVIII. Audits S ta te m e n ts 1 - 5.......................................... 4 9 F
w A
1735 243
Page 2 REVISION SHEET e-k Revision Number D ate Summary Initials QA-R M-001 - A 11/16/79 Total revision per receipt of MFS 10CFR 71, Appendix E g4 Acceptance Crtteria - Trans-portation Packages for Normal Form R adioactive Material,
from the U. S. N. R. C.
(
1735 244
Page 3 6%
INTRODUCTION J. L. Shepherd and Associates manufactures shipping containers for radioactive materials in Type A, Type B and large quantity categories, in both " Normal Form" and "Special Form", for its own and other's J. L. Shepherd and Associates also uses its own and other manu-use.
facturer's containers for the transportation of radioactive materials as desrcibed above. The Q. A. Program, described in this inanual, pertains to quality assurance in design, manufacture and use of the above containers as called out in 10CFR71, Appendix E.
Because of the specialized nature of its business, i. e. products involving radio-activity, J. L. Shepherd and Associates maintains all nece ss ary equip-ment for calibration and radiological control of its products. Membe rs of its staff personally perform all test on equipment related to this aspect of operation.
r-k
(
1735 245
10 CFR 71, Appendix E Acceptance Criteria r-(
I. ORG ANIZ ATION Page 4
- 1. Statement of Responsibility J. L. Shepherd and Associates implements the Quality Control / Quality Assurance Program, as follows, as normal operational procedure in the design, manufacture and use of Type A, Type B and large quantity categories of both " Normal Form" and "Special Form" shipping con-tainers for radioactive materials, for its own and other's use and the use of these containers made by other manufacturers.
J. L. Shepherd and Associates is responsible for the continued imple-mentation of this program on future projects.
J. L. SHEPHERD
') ],j j
- l. j C. H. PR EHOD A f,dg h,r_
/
'd $6 T'-
R. N. DONELSON M.F. SHEPHERD Q.
dM g $M
- u. IRISH cs 1735 246
Quality Control Manual Page 5 mk QUALITY PLANNING For each job undertaken by J. L. Shepherd L Associates, prior to the time purchase orders are issued to subcontractors or to vendors for raw materials, a work plan is drawn up for the contract. This work plan includes:
1.
A complete work schedule, including all outside purchases:
2.
A comptece cost schedule; 3.
A complete quality assurance program for both the raw materials and the subcontracting to be undertaken as part of the job.
This quality assurance program takes into consideration the quality control procedures that will be necessary for satisfactory performance of the contract and outlines detailed specifications for mate rials and subcontracting, as well as quality assurance check points, time of inspection inst uctions to vendors, related to manufacturing as well as equipment to be used in undertaking quality assurance programs.
Costs. As part of the cost records of all jobs, all direct costs as attributed to quality assurance are included in a separate category and are available g
for purposes of evaluation and futtere planning. These costs include informa-tion to identify the correction of non-conforming msterials and correction of defective work.
R e co rd s.
Forms are prepared and forwarded to subcontractors covering the various areas of quality control to be checked by these people, as out-lined above, and these are returned to J. L. Shepherd & Associates.
In addition, intermediate and final inspection forms and records are per-manently maintained at J. L. Shephe rd & Associates, along with all necessary radiological data, such as leak test certificates, calibration ce rtificates, exte rnal radiation levels, and other records that pe rtain to the radiological aspect of the equipment, as required by law and good quality assurance p rac tice s.
Corrective procedures. A program for corrective procedures is maintained, which includes the following:
1.
Monitoring and review of corrective actions, to a ssure their effectiveness; 2.
Introduction of required improvements:
3.
Analysis of scrapped products to determine reasons for non-conformity:
4.
Analysis of methods and processes of work performance.
s 1735 247
Quality Control Manual Page G FACILITIES & STANDARDS Drawings and Specifications. Engineering ic to maintain the central current drawing and specification file.
Prior to release for fabrication, all drawings and specifications are to be reviewed for adequacy in regard to standard design practices and end-product Approval by engineering and quality assurance is required prior to use.
release.
Changes are to be documented through the u se of De sign Change Orders and Specification Change Orders. Changes require the approval of Engineering and Quality Assurance.
Engineering is responsible for obtaining Government approval for changes as required and for transmitting change information to the Government as required.
Engineering is to be responsible for removing obsolete drawings and speci-fications from all issue points and for recording effectivity points.
The following section of the Quality Assurance Program may be broken into three categories: (1) those shipping containers /overpacks made in confor-mance with specific DOT fabricati<>n specifications as called out in DOT regulations such as, but not limited to, Paragraphs 178.104 and 178.194; (2) shipping containers and overpacks made in conformance with DOT general packaging performance criteria such as, but not limited to, Paragraph 178.350; and (3) shipping containers and overpacks designed to ship large quantities of radioactivity for which NRC Certificate of Compliance and licenses are required.
(1) All drawings and design specifications must be checked for conformance with fabrication specifications as called out in the pe r tinent DOT specifica-tion and approved by the cognizant Quality Assurance Manager or General Manager before release for fabrication.
(2) All drawings and fabrication specification s, and all outside purchase specifications for units out purchased, must be checked and approved by the cognizant Quality Assurance Manager or Gene ral Manager prior to release fo r fab rication and/or purchasing. For this equipment, a prototype test of each class of containers which is the most likely to fail unde r the pe r tinent conditions of transport will either be tested or calculations will be made and
{
approved by the cognizant Quality Assurance Manager of General Manager which show that the containers will meet the perti nent transport conditions.
1735 248
Quality Control Manual Page 7 E,
(3) All per ti nent data and calculations, including drawings, as called out in 10 CFR part 71 related to license applications and Certificate of Compliance applications for Type B and large quantity con:aine rs will be checked and approved by the cognizant Quality Assurance Manager or General Manager prior to submission of the package containing data to the NRC. After the Certificate of Compliance and license have been issued and prior to the fabri-cation of the approved unit, all drawings and purchase specifications for m1terial must be checked and approved by the cognizan: Quality Assurance Manager or Gene ral Manager.
C e
s 1735 249
Quality Control Manual Page S PURCHASING As noted in previous sections, J. L. Shepherd & Associates prepares a schedule of materials to be purchased, as well as all subcontracting for each job prior to initiation of work on the contract. Purchase orders which are let include all pertinent data, including a description, requirements for manufacturing, testing and packaging, and inspection, as well as any qualifications and approvals which must be met on Government contracts.
All pertinent drawings and manufacturing procedures are included as part of purchase orders.
J. L. Shepherd & Associates purchase orders also re-quire that all suppliers or subcontractors are to notify J. L. Shep herd &
Associates and obtain approval before any changes in design, ie: d rawing changes, inspection changes, etc., are undertaken.
In cases where shipment is made directly to the user, all instructions regarding shipment are included.
J. L. Shepherd & Associates maintains a qualified vendors list, from which vendors are selected, based upon past performance as related to the greater
(,
than ten years' expe rience of Messrs. Shepherd, Donelson, and Doonan in dealing with vendors in this area.
All raw m1terials which are purcitased directly by J. L. Shepherd & Associates are inspected by J. L. Shepherd & Associatas at time of arrival, either at J. L.
Shepherd & Associates' facilities or at the plant of tne vendor who will be using the se mate rials.
In case t where the subcontractor provides the mate rials on subcontracts let by J. L. Shepherd & Associates, these vendors are required to establish quality assurance procedures and records for raw materials received, including per-formance of fabricated parts purchased.
In case of subcontracts for manufacturing, J. L. Shepherd & Associates per-forms vendors surveys and evaluation prior to the letting of the subcontracts.
In cases where materials of a radiological nature are subcontracted, J. L.
Shepherd & Associates requires control and quality assurance for these materials from vendors, who must submit to J. L. Shepherd & Associates detailed information for perminent records relative to the quality of these products, ic: leak test information on sealed source s.
(
The following terms and conditions related to quality control will apply to all purchase orders for any type of radioac'i re sources purchased by J. L. Shepherd 1735 250
Quality Control Manual Page 'l
.k and Associates:
No source shall have greater than 1000 dpm removable contamination at time of shipment; Each source shall have undergone a seven-day leak test in accordance with HRC and agreement state requirements prior to shipment; A signed leak tast certificate which calls out the following:
(1) Source description (2) Source number (3) Date of leak test (4) Results of leak test (5) Method of leak test will be included with each shipment, attached to the packing list. A second copy will be sent via mail at tine of shipment.
Shields. All shipping containers will have the following maximum levels of removable contamination:
2 (1) B e ta-gamma 200 dpm/100 cm
(
(2) Alpha 100 dpm/100 cm2
'~
Attached to each packing list prior to shipment will be a signed report form showing that the container has been checked both for contarnination and for external radiation levels and giving actual values of these tests.
All shipments will be made in accordance with applicable ICC regulations, and all shipments will be properly labeled with the necessary data, iacluding Bureau of E.xplosives numbe r, where required.
Failure to comply with any of the above qualitf co ntrol requirements will result in rejection of the shipment and its immediate return.
K 1735 251
Quality Control Manual Page IO N
MANUFACTURING CONTROL Mate rials Control. Quality Assurance will insure that all incoming material is inspected, tagged, and segregated as received.
Non-conforming Materials and Parts. A Material Review Board is to be estab-lished for determing disposition of non-conforming items. The MRB will include representatives of Engineering and Quality Assurance and the Government rep re sentative.
Laboratory testing is to be employed as necessary and records of such tests maintained by Quality Assurance.
Processing Control. Engineering is responsible for establishing and maintaining detailed work instructions for processing operations.
Engineering and Quality Assurance is responsible for establishing in-process inspection points. Such points are to be designated by Engineering and approved by Engineering and Quality Assurance prior to release for fabrication.
(
Quality Assurance is responsible for determining that these inspections are perfoi med and that parts are properly identified and segregated. This applies also to sub-contractors and vendors.
(
1735 252
Quality Control h!anual Page il
^
\\
INSPECTION STATUS Quality Assurance is to provide the mec:tunism for identifying the inspection status of parts and assemblies. This may include tags, s tamp s, or routing cards as app.ropriate.
9q e
1735 253
Quality Control Manual Page I,'
s SOURCE TEST PROCEDURES Quality Control. Pre-inspection--material certification, helium leak te st, dye penetrant.
Pre-weld test specimens--one liner, one capsule sectioned and checked for weld penetration; minimum penetration 75% of wall thickness.
Post-weld test specimens--one liner, one capsule sectioned and checked for weld penetration: minimum penetration 75% of wall thickne ss.
Leak test, liner--Ethylene glycol to 10-4 cc/sec.
Leak te st, capsule--Ethylene glycol to 10-4 cc/sec.
Heat cycle test, source--2 hours at 200 C., repeated after heat cycle.
Contamination te st, source--0. 01 uc/100 cm2 by wipe test; maximum per source less than. 005 uc.
f' Storage te st, source--7 days leak t'est and contamination test repeated after s to ra ge te s t.
Special Form Tests. Free drop -- A free drop through distince of 30 feet onto a flat essentially unyielding horizontal surface, striking the surface in such a position as to suffer muimum damage.
Percussion -- Impa ct of the flat circular end of a 1" diameter steel rod weighing three pounds, dropped through a distance of 40".
The' capsule or material is placed on a sheet of lead, of hardness number 3. 5 or 4. 5 on the Vickers scale, and not more than one inch thick, supported by a smooth, e ssentially unyielding su rface.
0 Heating -- Heating in air to a temperature of 1,475 F. and remaining at that temperature for a period of 10 minutes.
Immersion -- Imme rsion for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> in water at room temperature. The water shall be at pH6 - pH8, with a maximum conductivity of 10 micro-ohms /cm.
Final In spec tion. Final inspection requirements are to be established by Engin-eering and Quality Assurance.
{--
Quality Assurance is responsible for assuring inspections are made and records of same maintained. Quality Assurance is also responsible for obtaining Covern-ment approvals as required.
1735 254
Quality Control Manual Page /3
(
MEASURING AND TEST EQUIPMENT Quality Assurance is responsible for maintaining equipment in first class condition and e stablishing calibration requirements and frequency. Records of all calibra-tions are to be maintained.
Quality Assurance is to monitor all vendors to assure that vendor's test equip-ment is properly maintained and calibrated.
r u
1735 255
Quality Control Manual Page "!
STORAGE, PACK AGING, DELIVERY Engineering is responsible for establishing requirements for storage, packaging and delivery, including any special requirements for radioactive materials.
Attention is to be given to Government regulations, such as MFC and ICC regulations, in addition to the contractual specification s.
Quality Assurance is responsible for assuring that these requirements are met and that records of such inspections are maintained.
An individual log sheet (sample enclosed) will be maintained for all Type B, Certificate of Compliance shipping containers /overpacks routinely used by J. L. Shepherd & Associates in conjunction with transportation of radioactive ma te rials.
.T Is.
1735 256
~
Quality Control Manual Page '<
AUDITS On an annual basis, all log sheets covering containers routinely used by J.L.
Shepherd & Associates as well as all pertinent data sheets covering shipping containers manufactured by J. L. Shepherd & Associates will be audited by ou r Accounting Department.
C I
1735 257
(h
/3 6
?,
'O.~
w
-00 nO p ::. 0 5 :r n
- m no"n,n
-o v
o>
a.o n -
v
= oC
[~o.sa"D;r 3
ga v
N 1
J. L. SHEPHERD 32c" 7-n n 3. C 0
H Gene ral Manage r p"n@
o a
'4 R adiological Safety Officer e
I I
R. N. DONELSON C. H. PR EHODA
.g M.F. SHEPHERD M. IltISH
/
Chie f, Enginee ring Accounting Production Control Shop Foreman O. A. Manage r Purchasing Q. A. Manuals R adiological Safe ty i
i t
I a
l i
t 8
I I
I I
g g
I 3
I I
I 4
J. S. COllEN i
I g
i r _
_1. _ _
,,,g I
Purchasing 8
g i
3 I
i I
l s
a l
i e
i g
i I
8 g
i a
3 8
8 i
J.DOONAN I
l_t________3 I
I Claie f, Q. A. Inspec tor 6
l J
i r_____
N I
I i
u T. J. SIIEPHEltD J. S. SHEPHERD I
1 m
,3 Engine e ring
---2 N
O. A.
Ins pe c to r O. A. Ins pe c to r
( J1 Itadiological Safety-00 Fune tions
I. ORGANIZATION f
Page /7 ti
- 4. Job Desc ription - C. H. Prehoda Clara H. Prehoda, Sec re tary-Tre asu re r. Accounting, Purchasing.
Under the direction of J. L. Shepherd, hirs. Prehoda is responsible for accounting and purchasing procedures and job cost records. The company books are set up to maintain complete records of costs, both direct and indirect, on a job by job basis. She is also responsible for maintaining all pertinate correspondence, records and contracts, including customer's licenses.
The " Voice" of J. L. Shepherd and Associate s, hirs. Prehoda attended Columbia Union College, W ashing ton, D. C. and has twent'f-three years' experience in customer relations in the nuclear field. She specializes in handling customer requests, inquiries and problems promptly, efficiently and cheerfully, aided by her excellent command of technical info rmation.
p-1 C
1735 259
I.
ORGANIZATION Page '?
_i L 4.
Job De sc riptions -- R. N. Donelson R.N. Donelson, Chief Engineer, and Quality Assurance Manage r.
M r.
Donelson is responsible for all engineering and for the quality assurance program of J. L. Shepherd & Associates (JLSLA). He has specific respon-sibility for vendor selection and qualification and vendor quality assurance programs, purchasing and control of raw materials, drawings and draiving change control. Mr. Donelson also has responsibility for quality assurance of radiological aspects of JLS&A products, including calibration, leak test-ing, and certification of radiological safety, both of units in which this work is performed at a vendor's facility, and those units on which work is per-formed in the field.
Radiation safety and engineering consultant, Mr. Donelson has a B.S. in Chemical Engineering from the Universitf of Washington and is a Certi-fied Health Physicist. His thirty-one (31) years of experience in the nuclear field include the design, engineering and installation of all types of irradiation facilities and plants for handling radioactive materials, as well as production management. Mr. Donelson also acts as an independent consultant in the radiation safety field.
.f k
1735 260
I.
ORGANIZATION Page '7 4.
Job Descriptions -- Mary F. Shepherd
..lary F. Shepherd, Production Control and QA Af anuals. N!s. Shepherd, working with R. N. Donelson (Engineering), Clara H. Prehoca (Purchasing) and Malford Irish (Shop), and under the direction of J. L. Shepherd, is re sponsible for correlating the progress in all departments on a daily.:ob-by-job basis, expediting or delaying progress as warranted, and notification to the proper depa r tments. She is also responsible for approximate scheduling of work in progress, and tests and inspections as necessary in weekly bi-departmen-tal conferences.
Ms. Shepherd's QA responsibilities include the distribution and update of QA Manuals as necessary.
s
(
1735 261
I.
ORGANIZATION Page 7.0
?"
4.
Job Description -- Malford Irish Malford Irish, Shop Foreman, working directly with J. L. Shepherd, R. N.
Donelson, Clara H. Prehoda, and Mary F. Shepherd, has the responsibility of delegating proper materials to the respective jobs and supervising the work in progress at JLS&A.
e, Ci t.
1735 262
I.
ORGANIZATION Page 7. 3
,..(
4.
Job Description -- Jerri S. Cohen Jerri S. Cohen, Purchasing Officer. Under the direction of R. N. Donelson and the Engineering Department, as well as Clara H. Prehoda, Ms. Cohen is responsible for proper documentation on purchase orders and the place-ment of them to vendors, with all applicable specifications. She is also responsible for notification on all delivery dates to Mary F. Shepherd, Production Control, so that production, testing, and inspection procedures can be scheduled accordingly.
r s.
1735 263
I.
ORGANIZATION Page 7 '.
g s
4.
Job Description -- Joseph Doonan Joseph Doonan, Chief Inspector. Under the direction of Mr. Donelson, Mr. Doonan has responsibility for inprocess inspection and sub-assembly inspection at various vendors' and contractors' facilities. Mr. Doonan also h:. responsibility for inspection of incoming materials, to assure that they meet specifications called out by purchase orders on which they are obtained, and for determining that these raw materials are properly tagged, either at time of receipt at the vendors' facilities or at time of shipment from JLS&A to vendors' facilities.
C u
t, 1735 264
I.
ORGANIZATION Page 2.3
,C 4.
Job Description -- Thomas J. Shepherd Thomas J. Shepherd, Engineering and QA Inspector. Under the direction of R.N. Donelson (Engineering), Mr. T. Shepherd is responsible for the distribution of drawings and specifications to the appropriate departments a fter approval.
Working with Mr. J. Doonan (Chief, QA Inspector), Mr. T. Shepherd per-forms QA Inspections as required.
in.
Q O
F
\\<
1735 265
I.
ORGANIZATION Page 2.4 4.
Job Description -- Joseph S. Shephe rd Joseph S. Shepherd, QA Inspector and Radiological Safety Functions.
Working with J. Doonan (Chief, QA Inspector), Mr. J. S. Shepherd pe r-forrns all inspections as necessary. Unde r the direction of J. L. Shepherd and R. N. Donelson, Mr. J.S. Shepherd is responsible for the inspection of components related to radiological safety functions.
(,r e
9 L
1735 266
I. ORGANIZ ATION Page
- 2. c,
'c.
- 5. Job Description and Qualifications - Head of Q. A. Program J. L. Shepherd, President, General Manager and Head of Q. A.
P rog r am. Mr. J. L. Shepherd is responsible for the gene ral manage-ment of the company, specifically related to sales. contrac t manage-ment products and quality assurance.
Mr. Shepherd is personally responsible for the final inspection of all products af ter completion, including those related to radiological safety, before delivery to the cus tome r.
Mr. J. L.
Shepherd has a D. S. from Loyola University of Los Angeles.
He did graduate wok at Notre Dame and University of California at Los Angele s, and has had Twenty-six years experience in product develop-ment, applications, engine e ring, s ale s, marketing and general management in the nuclear field. He specializes in the evalu ion and selection of the optimum radiation sources and/or tracers and related equipment for nuclear applications, based upon the customer's total require me nts, including such parameters as licensing, radiation safety, cost and reliability and proper shipping containers as required.
r' 4
1735 267 ase
I. ORGANIZATION Page 1%
.c, Q.
- 6. Statement of Responsibility.
J. L. Shepherd, C. H. Prehoda, M. F. Shepherd, M. Irish, J. Doonan, T. J. Shepherd and J. S. Shepherd have the resposibility and authority to reject unsatisfactory materials, stop unsatisfactory work and to supervise further processing after corrections have been made.
M. Irish y h~
/
J. L. Shepherd 7,; :.'[
C. H. Prehoda' l$delt.t.. f'/A d </1 J. Doonan
)j R. N. Donelson
.w_/s T. J. Shephe rd 9,41 M
M. F. Shepherd - W J. S. Shephe rd g
J. L. Shepherd, R. N. Donelson and C. H. Prehoda have the futher responsibility and authority to s top the delivery and/or installation of nonconforming products or materials.
/
J. L. Shephe rd 0 ),) /c_) y ( /
/
g.
g;f,g fpy,',, J / f < K.<(
C. H. Prehoda R. N. Donelson A statement of this responsibility is signed by each individual and posted in a visible location.
fL.
1735 268
II. QUALITY ASSURANCE PROGRAM Page U v
1.
Statement of Verification of Assessment of Quality Assurance Program The officers of the Quality Assurance Program (QAP), in addition to daily communication, hold weekly conferences in conj unction with appropriate de partmen ts, to review the status of each job in regard to design, purchasing, work release, work in progress, corrective procedures, inspections, te sting, safety, storage or shipment, proper documentation, corrective action (if applicable) and shipment, on whichever phase of operation is pertinent to that job as well as overall views of all work in progress. Annual audits to determine compliance, as well as for accounting and inventory purposes, are performed and reviewed by the officers of the QAP.
2.
Distribution of Quality Assurance Program Manuals Each officer of the QAP retains a QA/QC Program Manual. A master copy is kept and a copy is also made available for any employee to refer to.
(Each new employee is made familiar with the m1nual as part of the Training Pro -
g ram. )
M. F. Shepherd is responsible for distributing approved revisions to all copies of the manual and advising the holders thereof of the revisions.
f' 3.
Statement c' Verification that Quality Assurance Program Requi-ements are applicele to Outside Vendors J. L. Shepherd & Associates retains the right to supervise and inspect pro-ducts at vendor's and contractor's facilities and/or to reject nonconforming materials; and has agreements with vendors and contractors stating such to maintain our Quality Control mandatory requirements.
4.
Safety-related Systems, Structures and Components Controlled by Quality Assurance Program All mechanical, electrical, and electronic components, as well as all com-plete systems, are controlled and covered by the CAP.
5.
Statement of Verification of Resolution of Disputes If, and when, disputes arise conce rning the quality of a product between the different departments, a review of the product's functions, specifications, and compatability with the QA/QC Program, as well as NRC and DOT Cri-te ria is made by the QA officers and appropriate offices. Reviews are made at the weekly conferences or as needed when all pertinent data is gathered.
Agreements are subject to review by J.L. Shepherd for final approval.
r 1735 269 m.
,, ~
II. QUALITY ASSURANCE PROGRAM Page If b(o.
6.
Statement of Verification that Trainiag Program is implimented J.L. Shepherd & Associates maintains a training program for all new employees and employees assuming additional responsibilities. This program provides a thorough examination of the QA/QC Program, the purpose of maintaining this program, each QA officer's authority delineated and how it is e ffe c -
tive, as well as how the employee functions within the program.
In as much as Shepherd & Associates is a small business, each employee is not only responsible to the QA officers, but is directly responsible for his/her own work within the company. Hence, in the training program, each indivi-dual is trained (and continuously monitored in the system of checks and balances maintained in the weekly review by the QA officers to whom the employee is responsible) to be effective in the continuous effective functioning of the QAP.
A complete documentation of this program is on file at Shepherd & Associates.
All personnel are adequately licensed or certified, ie: Health Physicists, welders, machinists, for example, when applicable. All license s and certi-fications are kept current. If an employee is not performing to the specifi-cations maintained by Shepherd L. Associates, they are subject to a retraining 7
program before continuing with their responsibilities or their employment is te rminated.
7.
Statement of Verification that Qualit'f-Related Activities are Performed According to Predetermined Measures J. L. Shepherd & Associates performs all qualitt-related procedures, ie:
inspections and testing, in accordance with pre-dete rmined procedures which specify the equipment to be used, if necessary, and environmental conditions.
Inspectors are required to determine and document that all prerequisites have been satisfied before inspection and/or testing.
1735 270 eo
-..-......s
_.....__.-.--____._..-._m
._...,..-.-,_.....m_..
III. DESIGN CONTROL Page 7.'!
1 1.
Statement of Verification of Responsible Design Procedures J. L. Shepherd & Associates has an established design procedure for its products.
Because of the nature of our business and products, ie: products involving radioactivity, all products are licensed by the proper licensing authority and all new products have licenses pending.
iherefore, in the initial design of a product, the first step is to provide licensing authorities with all pertinent drawing s.
Sale s drawings, if applicable, are made per customer requirements and licensing crite ria.
Engineering is to maintain the central current drawing and specification file.
Prior to release for fabrication, all drawings and specifications are to be reviewed for adequacy in regard to standard design practices and end-product use. Approval by engineering and quality assurance is required prior to release.
Changes are to be documented through the use of Design Change Orders and
/'
Specification Change Orders. Changes require the approval of Enginee ring and Quality Assurance (QA).
~
Engineering is responsible for obtaining Government approval for changes as required and for transmitting change informstion to the Government as required.
Engineering is to be responsible for removing obsolete 2 rawings and specifi-cations from all issue points and for recording effectivity paints.
2.
Stateme it of Verification of Co.npliance wi'h Regulatory Requirements in Drawings J. L. Shepherd & Associates Engineering Departmer.t and QA Department reviews all product drawings, specifications for materials, procedures and instructions, with a final review by J. L. Shepherd or R. N. Donelson on each job to verify that they meet all regulatory requirements and licensing criteria.
3.
Statement of Verification that Quality Standards are Maintained.
J. L. Shepherd & Associates' Engineering Department main'ains a comple te list of specifications for each product. It issues a Bill of Materials to the f'
Purchasing Department with these specifications. Anf changes from these specifications by the vendor or sub-contractor is subjected to review by the 1735 271
...__m.
III. DESIGN CONTROL Page 30 m
M.
Engineering Department and QA Department before purchase is made. - Any change or deviation on a particular product is noted on the specification documents for that particular product. All purchases are individually checked on delivery to verify that they do meet specifications before they are accepted. The Shop Foreman is directly responsible to the QA Officers for production which is inspected at various stages of completion.
4.
Statement of Verification of Design Control J. L. Shepherd & Associates Engineering Department and QA Department reviews each product design with all revisions approved before release for manufac ture. Any deviation from this is subject to a review by the QA Department before approval or rejection. Inspection and test criteria are identified and made available to the QA Department before release.
5.
Statement of Verification of Adequacy of Design J. L. Shepherd & Associates QA Department and Engineering Department insures the proper selection of components and design verification of each unit by means of prototypes from which licensing is applied. The proto-7 types are thoroughly tested and inspected in all stages to verify that they meet all licensing authority criteria and design specifications. All inspec -
tion and test criteria are documented and made available to the QA Depart-ment, which documents acceptance or rejection and all pertinent data thereof.
6.
Statement of Verification of Design Department Controls J. L. Shepherd or R. N. Donelson of Shepherd & Associates are responsible for the final design verification resiew after reviews' by the Engineering Department and by the QA Department.
7.
Statement of Verification of Design Change Control J. L. Shepherd & Associates maintains design specification change controls on the ssme basis as the original designs. See III. 1, 2, 3, 4, 5, & 6.
8.
Statement of Verification of Engineering and QA Responsibility and Autho rity J. L. Shepherd & Associates maintains written agreements delineating the areas of responsibilites and authority of each member of the Engineering Department and the QA Department, which are agreed upon and understood
(
at the completion of the Training Program.
w 1735 272
_. ~..----_ ---._ _
1 _.,...... -.
IV. PROCUREMENT DOCUMENT CONTROL Page Sn n ~.
b 1.
Statement of Verification of Purchasing Departrnent Procedure J. L. Shepherd & Associates' Purchasing Deparment maintains a definite sequence of action in any purchasing operation. A list of procedures is posted in the Purchasing Department (PD) Office and is explained in the employee training program.
2.
Statement of Purchase Orders--Appendix E Criteria Verification J. L. Shepherd & Associates' Purchasing Department routinely indentify 10CFR, Part 71, Appendix E criteria, as applicable and is described in the QA Program prope r.
Standard purchase order forms designate spaces for this information.
3.
Statement of Appropriate Reference of Specifications on Purchase Orders J. L. Shepherd & Associates' Engineering Department provides appropriate refe rences to technical requirements, ie: regulatory requirements, material and component identification requirements, drawings, specifications, codes and/or industrial standards, test and inspection requirements and special F
process instructions, on the. Bill of Materials xhich is submitted to the PD to be inchded on purchase orders, when applicable.
4.
Statement of Appropriate Reference of Documentation on Purchase Orders J. L. Shepherd & Associates' Engineering Department provides appropriate refe rences of documentation, ie: d rawing s, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedures qualifications and chemical and test 'results of material, on the Bill of Materials which is submitted to the PD to be included on purchase orders and provided to vendor, if applicable.
5.
Statement of Verification of Appropriate Documents Retained by Vendor and Delivered to Purchaser J. L. Shephe rd & Associates' Engineering Department provides the appropriate references of records, certification or test reports to be retained, controlled and maintained by the supplier and those delivered to the purchaser prior to use of item, on the Bill of Materials which is submitted to the PD to be included on the purchase orde r if applicable.
6.
Statement of Verification of Purchase Order Containing Right of Access l
Clause 1735 273
IV. PROCUREMENT DOCUMENT CONTROL Page 22.
r..
%./
J. L. Shepherd & Associates purchase orders contain an agreement clause covering the right to access to the supplier's facilities and records for a source inspection audit, when applicable.
7.
Statement of Verification that Purchase Order Revision are Subject to Approval As stated in III, #3, "Any changes from these specifications by the vendor or subcontractor is subjected to review by the Engineering Department and QA Department before purchase is made. Any change or deviation on a particular product is noted. "
(s'
(,
1735 274
V.
INSTRUCTIONS, PROCEDURES & DRAWINGS Page 72 4
1.
Statement of Verification that Activities Affecting Quality are Accom-plished in Accordance with Specifications J. L. Shepherd & Associates (JLSLA) has established with the impleme sta-tion of the QA/QC program that activities affecting the quality of a product are adhered to in all phases of operation according to prescribed documenta-tion of instructions, procedures and/or drawings.
2.
Statement of Verification of Clear Sequence of Actions Concerning Instruc-tions, Procedures, and Drawings JLS&A has established with the implimentation of the QA/QC Program that there is a clear sequence of procedure in the preparation of, review, appro-val, and control of instructicas, procedures, and drawings.
3.
Statement of Verification of Quality Assurance Department Responsibility JLS&A QA Program Department has the authority and responsibility to review inspection plans; test calibration and special process procedures; drawings and specifications; and all changes thereto and/or acceptable f.^
alte rnatives, under the provision's of the QA Program, and does so.
w
<.c 1735 275 t
VI.
DOCUMENT CONTROL Page
~3. 4
.4 1.
Statement of Verification that the Issue of Documents and Procedures the reof are Procedurally Controlled JLS&A Engineering Department, working with the QA Department and Purchasing Department, have adequate procedural controls to check if review, approval and issue of documents and changes thereto, prirr to release, on a product, are satisfactory to quality requirements.
2.
Statement of Verification that Changes to Documentation are Made by the Original Organization that Prepared Initial Document JLSLA Engineering Department, when notified of the need for change or modification by itself or other departments, in conjunction with the QA De pa r tment, reviews and approves or rejects revisions to the original documet t as needed.
3.
Statement of Verification that Revisicas are Made on Appropriate Documents JLS&A Engineering Depa rtment i,s re sponsible for making all nece ssary revisions on all related documents of a project, after approval thereof,
~
prior to the implementation of these changes.
4.
Statement of Verification that All Pertinent Documents are Av1ilable at Site where They are to be Implemented JLSLA Engineering Department is responsible for all pertinent documents related to a job to be available at the site where they arc. to be implemented, prior to starting work. The Engineering Department is also responsible that the Purchasing Department has all pertinent documents to accompany the purchase order (if applicable) to the supplier before work begins on the project.
5.
Statement of Verification that Master Lists of Revisions are Current and Appear on Appropriate Documen ts JLSLA Engineering Department keeps a current master listing of revisions on products so that revisions are identifiable and is respon;ible that the appropriate revisions are on documents and distributed thus.
t' 1735 276
VII. CONTROL of PURCHASED MATERIAL, PARTS & COMPONENTS Page ?5
.u 1.
Statement of Verification that Qualified Personnel Evaluate Suppliers for Acceptability R. N. Donelson, Chief Engineer and QA Manager of JLS&A, is qualified and responsible for vendor selection and qualification of vmdor QA Program to provide materials that meet specifications.
2.
Evaluation of Suppliers R. N. Donelson, Chief Engineer and QA Manager of JLSLA, who is respon-sible int supplier selection uses the following criteria for approving a vendor:
The supplier's capability to comply with the elements of Appendi:c E to 10CFR Part 71 that are applicable to the type of material, equipment, or se rvice being procured.
A review of previous records and performances of suppliers who have provided similar articles of the tfpe being procured.
A survey of the supplier's_ facbities and QA Programs to deter-C mine his capability to supply a product which meets the design, manufacturing, and quality requirements.
3.
Statement of Verification that Supplier Evaluations are on File JLS&A maintains carrent files on the results of supplier evaluations made by R. N. Donelson, Chief Engineer and QA Manager, as well as current specifi-cations on products supplied.
4.
Statement of Verification that Inspection and/or Supervision of Supplie rs is Performed At the weekly meetings of the QA Department and appropriate departments, it is dete rmined if and when it is required that the Chief Inspector or appro-priate office r be present during fabrication, testing and shipment of a pro-duct, to assure accordance with purchase order specifications.
5.
Statement of Verification of Minimum Records supplied to Purchaser JLSLA requires as a minimum from all vendors the following documentation:
,7 Documentation that identifies the purchased material or equip-4 ment and the specific procurement requirements (e. g., codes, jJ }//
VII. CONTROL of PURCHASED MATERLiL PARTS & COMPONENTS Page % .n standards, and specifications) met by the items. Documentation that identifies any procurement requirements which have not been met together with a description of these nonconformances dispositioned " accept as is" or ' repair." N ote: Contingent upon acceotance by JLS&A, all conconforming items must be repaired or replaced and eeritucaWii a_2 J 6. Statement of Receiving Inspectors Acceptability Criteria and Responsibilities The Chief Inspector for JLS&A is responsible for,and will not accept, products that do not meet the following criteria: The material, component, or equipment is properly identified and corresponds with the identification on receiving documenta-tion. Material, components, equipments, and acceptance records are inspected and judged acceptabl9 in accordance with predetermined inspection instructions, prior to installation or use. Inspection records or certificates of conformance attesting to the acceptance of material and components are available prior to installation or use. Items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for further work. fs 1735 278
4 V.i. IODITIFICATION AND CONTROL C7 ' ' ATE R2sL3, PARTS, L COMPONENTS . o. o y ay. 4 1. Statement of Verification of Establia.:cd Procedures Used for Identivf n; i and Controllina Ma te rials a Chiaf Inspector of JLSLA uses a standard procedure for identifyin,.; all pro-ducts received, as part of the QA/QC Pro; ram. 2. Statement of Verification that Products are Identified Prope rly As part of the standard receiving procedures of the Chief Inspector of JLSLA, all croducts are identified and marked. This identification and marking is
- .irectly traceable to all pertinent records and this system precludes the use of incorrect or defective items.
3. Statement of Verification that Safety-Related Mate rials are Identified P rope rly .is stated in VIII, !/2, all Snns are identified and ma.rhad, directly traceable to c.ll pertinent records, ie., drawings, specifications, purchase orders, te s t reports, including and e speciall'/ the safetf related items, which are thoroughly insp ected. .-~w Str.tament of Verification that the Locativn and 2 :cthod for Identifying P r ducts i:, not Harmful to Them. J1S A maintains a receivinq araa whe re aH p rodue:s a re identi'i-d 1ad m.s.rhed before alloc1 tion to prop 3r inventorf :rez.s. .z recen tag a rea and rn:thod of identification (s eve ral method s c. prop ria te to it2m) do not in any '.:. r interfora with the fit, function, or qualir, of a produc t. 5. Stat; ment of Verification that Product Identu cation N'imbersara ertfied before Ralcase '~ JL3 h.,, a s pa r t of the CA/ CC '3r og ram, r: 2ir23 t::1t an) i':m trom. .3 arf '2
- erifiad that it is the proper item for tnat job before rc.'.:ase fo r fab rica-tion, a s sem'aly, o r in s talla tion.
s~ VO E 1735 279
IX. CONTROL of SPECL\\L PROCESSES Page M 1. Statement of Verification that Special Processes are Procedurally Con trolled The Shop Foreman at JLS&A is directly responsible, in conjunction with periodic QA officer inspections, on each job, for the procedural control of special processes such as welding, heat treating, non-destructive testing, and cleaning for items in-house. The Chief Inspector is responsible for inspecting and controlling these processes at supplier's installations, as applicable. 2. Statement of Ve rification that Procedure s, Equipment, and Pe rsonnel Related to Special Processes Meet Applicable Specifications, Codes, and S tanda rds JLS&A Engineering Department and Shop Foreman, in conjunction with the QA Department, are responsible for m2intaining appropriate procedures, equipment, and personnel connected with applicable code s, standard s, and spe cification s. 2. Statement of Verification that Qualification Records Concerning Special {' Processes are Established and Cu'rrent As part of the implementation of the QA Program, the Enginee ring Depart-ment at JLS&A maintains current' qualification records of all areas associ-ated with special processes. In addition, copies of applica' ole records are filed in each job file. 7 1735 280
4 X. INSPECTION Page 23 r a' l. Statement of Verification that Inspection Program Verifies Conformance of Articles in Accordance with Established Procedures All inspections performed by JLSLA, which check conformance with quality associated areas, are performed in accordance with written and controlled procedures and are documented. 2. Statement of Verification that Inspection Personnel are Independent from Individuals Performing Activity Being Inspected Inspection personnel at JLS&A are independent from the personnel perform-ing the activity being inspected, qualifications and independence determined by the QA Department. 3. Statement of Verification that Inspectors are Qualified and Qualifications are Recorded The QA Departr tent of JLS&A is responsible for maintaining qualified in-spectors (in accordance with applicable codes, standards, and training programs) and the certifications and qualifications thereof are on file and C.., kept current. 4. Statement of Verification that Revisions are Inspected in Accordance with the Original Specifications Inspectors at JLS&A perform all inspections, including those on any modi-fications, repairs, or replacements, in accordance with the original design specifications and procedures or acceptable alternatives; and all inspections are documented. 5. Statement of Verification that Inspection Points are Established and Observed The Shop Foreman is responsible for the supervision of work, including holding work progress until it has been inspected, at the appropriate phases. The Shop Foreman holds work for inspection in accordance with predeter-mined inspection specifications and for informing the QA Department of forthcoming inspections at weekly meetings and time of inspection. rv 1735 281
XI. TEST CONTROL Page -id ii* W l. Statement of Verification that Test Programs are Este.blished, Doc 2-mented, and Peformed Accordingly Test Programs to determine if an item will perform satisfactorily are performed by JLShA Engineering and QA Departments and are perfomed in accordance with established documented specifications, and are fullf-documented. 2. Statement of Verification that Revisions in Design are Tested in Accor-dance with Specifications of the Original Design JLS&A Engineering Department, in conjunction with the QA Departmen, te sts all modifications, repairs or replacements to the original design is accordance with original specificaticus er acceptable alternatives. 3. Statement of Verification'that Test Results are Documented, Revie. ed, and Accepted by Appropriate Department All test program results are fully documented. They are then evaluated and de te rmined acceptable by qualifie,d Engineering and QA Department officers I.. of JLSLA. 1735 282
XII. CONTROL OF MEASURING & TEST EQUIPMENT Page MI ,.,s d 1. Statement of Verification that Measuring and Test Equipment are Pro-perly Calibrated JLSLA maintains properly calibrated measuring and test equipment, based upon required accuracy, purpose, degree of usage, stability characteris-tics, or other conditions affecting the measurement. Instruments used involving the measurement of radioactivity are calibrated at three (3) month intervals: all other instruments are calibrated yearly. 2. Statement of Verification that Measuring and Test Equipment are Identified and Traceable to Calibration Te st Data JLSLA requires and maintains serial numbers on all measuring and test equipment and requires all calibration test data to reference the instruments' serial number. 3. Statement of Verification that Measurements are Takt.:n, Documented, and Validated against Previous.V.easurements if Instrument is found to be out of Calibration Q. JLSLA performs new tests or measures (which are documented) to validate .c previous inspections in the event that an instrument is found to be att of calibration, and notifies appropriate parties, if applicable. 4. Statement of Verification that Calibration Meets Appropriate Standards JLS&A maintains National Bureau of Standards traceable calibration records on all instruments which measure radioactivity, and the se standards are referenced on all appropriate documentation. Other~ inspection instruments either meet nationally recognized standards or manufacturer's specifica-tions which are documented and are on file at JLS&A. 1735 283 (
- - ~ X III. HANDLING, STORAGE, -& SHIPPING Page d 'l .m s. 1. Statement of Verification that Special Requirements are Accomplished by Qualified Individuals in Accordance with VTork and Inspection Instructions In accordance with predetermined established work and inspection in struc-tions, qualified employees of JLS&A perform work related to special hand-ling, preservation, storage, cleaning, packaging and shipping regt.irements. 2. Statement of Verification that Conditions of the NRC and U.S. DOT Shipping Requirements are Satisfied before Shipment JLS&A performs a final inspection, before shipment, on all items pertinent to NRC and U.S. DOT specifications and conditions. Items must pass all criteria before shipment is made. 3. Statement of Verification that Shipping Papers are Properly Prepared JLS&A prepares (and keeps on file) all necessary shipping papers as required. Shipping papers on shipments containing radioactivity include the following documentatiom Date of shipment ( Customer '~ License of Customer Source information Shipping container type and device Radiation level at surface of shipping container Radiation level three feet (3') from surface of container Surface contamination In s trumen t Leak Test DOT class label Transport Index Truck placard requirement Shipping weight Freight Classification Also included with shipments are External Radiation Level Certificate, Leak Test Certificate, Calibration Certificate, Attenuator Certificate, if applicable. 4. Statement of Verification that Shipment Time is Consistant with Safe Transportation Time JLS&A routinely uses motor freight for shipments because the weight inhibits i fa st delivery c.nd our products' mtu:e does not demand it. Departure occurs after a package has passed final inspection to meet NRC, DOT criteria and 1735 284
XIIL HANDLING, STORAGE & SHIPPING Page 43 g MJ the customer has necessary licensing (if applicable) and is ready to accept delive ry. Shipments are monitored as applicable to the motor freight de-livery schedule and customer notification of arrival.
- e..
c m 1735 285
XIV. INSPECTION, TEST, & OPERATING STATUS 7_3 ' i Page w 1. Statement of Verification that Status of Packages is Known by Affected Organizations JLS&A QA Department, in conjunction with other appropriate departments (such as shipping, enginee ring, production, secretarial), is re sponsible that the appropriate documentation and identification of inspection, te s t, and operating status of packages is known and received by affected organizations, such as inter-departmental, shipping agents, and/or customers. 2. Statement of Verification that Removal of Inspection and Status Indicators are Procedurally Controlled JLS&A requires that all inspection and welding stamps and/or status indi-cators such as tags, markings, labels, or stamps, when removed from an item for fabrication, be checked with the Shop roreman at the time of removal (for verification purposes) for records of 'in-process work. Any stamps or status indicators to be applied to an item are done so after the appropriate inspector has inspected and passed an item and is also documented a cc o rdingly. (- 3. Statement of Verification that* Bypassing of Inspection Te sts or Other Critical Operations is Controlled The bypassing of inspections, tests, or other critical opera-ions is proce-durally controlled by documentation, work st ucture and procedure and daily communication, as well as weekly meetings, between all departments and the QA Department. 4. Statement of Verification that Nonconforming' Items are Identified The Chief Inspector at JLS&A is responsible for identifying and inspecting in-coming mate rials. Nonconforming items =.re so identified, not placed in inventory, but returned to vendor. If items are found to be defective or othe rwise nonconfo rming during procedural inspections, the se items are identified and either returned to vendor o r placed in a special inventory for rework and retesting. These procedures are establisheu to preclude the inadve rtant use of nonconforming materials. C 1735 286
XV. NONCONFORMING MATERIALS Page @ V,; 1. Statement of Verification that Nonconforming Items are Procedurally Controlled JLS&A has established and enforced procedures during receiving inspection and for subsequent inspections to assure that the identification, documenta-tion, segregation, review disposition are implemented, affected orgnizations are notified and that replacement and repair are carried out. 2. Statement of Verification that Nonconforming Item Documentation is' Complete When a non-conforming item is found during inspection or testing, the inspection or test individual of JLS&A is required to document' the reasons of nonconformance, identify the item, and signature the report; and sub-sequent appropriate action is taken. 3. Statement of Verification that Nonconforming Items are Segregated from Acceptable Items JLS&A maintains a separate inventory locati >n for nonconforming items, t{ which are identified as such, until appropriate action is taken. 4. Statement of Verification that Repaired or Reworked Items are Subjected to Original Testing JLSLA inspectors subject all replaced, reworked, or repaired items to the same documentation testing procedures per die original inspection, or by acceptable alternative testing procedures, e-C 1735 287
XVI. CORRECTIVE ACTION Page 'iG ~s 1. Statement of Verification that Evaluations are Conductec to Determine the Need for Corrective Action, if Required JLS&A does not accept or use nonconforming materials for use in a product, as established by procedural inspections at various ph.ses of operation. In the event that an inspection determines there is a nonconformance, such as failures, malfunctions, deficiences, or defectiveness, the Engineering and QA Departments jointly evaluate the need for corrective actions in accor-dance with established procedures. 2. Statement of Verification that Corrective Action is Initiated, if Required In the event of nonconformance, the Engineering and QA Departments of JLS&A evaluate all aspects of the nonconformance and determine the kind of corrective action to be taken to preclude reoccurance. This process is documented accordingly, before the corrective action is taken and reinspec-Led according to prescribed procedures. 3. Statement of Verification t!st Bedews cf Corrected Actions are Conducted ( The Engineering and QA Departme'nts of JLS&A conduct insp. ctions and follow-up reviews of corrective actions to determine if they are acceptable, and either close out required documentation and/or implement the se actions as part of standard operations, wliichever is needed. A. 1735 288
XVII. QUALITY ASSURANCE RECORDS Page 47 D 1. Statement of Verification that Documentation is Maintained Concerning Evidence of Quality and Safety of Items and Activities The Engineering Department of JLS&A maintains all documentation con-cerning the quality and safety of items and activities which affect quality and safety areas, with revisions and updates made annually, or as needed, or as required. 2. Statedient of Verification that Safety and Quality Related Documents Contain Required Information JLS&A QA records, maintained by the Engineering Department include operating logs: re sults of reviews, inspections, te sts, audits, and mate rial analyses; qualification of pe rsonnel, procedures, and equipment; and other documentation such as drawings, specifications, procurement documents, calibration procedures and reports; nonconformance reports; and corree-tive action reports. In addition, pertinent documentation is included with each job file. i^, 3. Statement of Verification that Quality Assurance Documents are Identi- '~ fiable and Retrievable JLSLA maintains a numerical and alphabetical system which cross references all QA documentation, as well as all associated documentation, throughcu: all filing systems in all departments. Through the implimentation of this system, all records are identifiable and retrievable. 4. Statement of Verification that a List of Required' Records and Storage Locations is Maintained JLShA maintains a master list of where required records may be located, which includes the use of the e stablished numerical and alphabetical iden*i-fication system. 5. Statement of Verification that Required Records are Kept on File JLSLA maintains complete files, including design related records, inspec-i:n and related QA documents, since the company was established in 1967, and update s tae se file s a s re gt ire d, ie., repairs or replacement parts, corres-pondence, e tc. These files are identifiable and retrievable per the master list discussed in XVII. 3 & 4. E %.~ 6. Statement of Verification that Inspection and Test Records Contain 1735 289 .~n.,,-- = _,--....--n
X VII. QUALITY ASSURANCE RECORDS Page 'i' L. Appropriate Information JLS&A Engineering Department has established and msintains inspection and test records which include the following crite ria: (1) A description of the type of observation. (2) Evidence of completing and verifying a manufacturing, inspeedon, or test operadon. (3) The date and results of the inspection or te st. (4) Information related to conditions adverse to quality. (5) Inspector or data recorder identification. (6) Evidence as to the acceptability of the results. c O s 1735 290
X VIII. AUDITS Page d' d3. 'Cs 1. Statement of Verification that Audits are Conducted in Prescribed Manner JLShA performs audits in accordance with prescribed procedures and check-lists. All audits are performed by employees who do not have direct responsi-bilities for the area being audited. Audits are performed interdepartmentally if those departments contain individuals who are qualified to do so. 2. Statement of Verification that Audits are Reviewed by Management JLS&A management personnel review all audits in their areas affected by the audit. Employees compile all audits and a complete report is made available to management for a comprehensive review. 3. Statement of Verification that Management Reviewing Audits have the Responsibility to Correct Deficiences The management personnel of JLS&A are responsible for correcting defici-encies as required after a review of the complete auding reports. 4. Statement of Verification that Deficiences Revealed by Audits are Re-C audited Regularly b JLS&A, at the receipt of an order, makes total inventory and appropriate audits at that time, to determine'the correct status of items. Special nota-tions and attention is made on items found previously deficient, cr ite m s frequently used. 5. Statement of Verification that GA Program is Audited Annually Qualified JLS&A management personnel, in conjunction with the QA Depart-ment, annually audits and review the entire QA Program and its implemen-tation with special emphasis on the safety related features. Other audits and reviews are performed as necessary, if re<,uired. r( 1735 291 u._ _s ~ e_. -~}}