Regulatory Guide 6.9
| ML003739257 | |
| Person / Time | |
|---|---|
| Issue date: | 02/28/1995 |
| From: | Office of Nuclear Regulatory Research |
| To: | |
| References | |
| RG-6.9 | |
| Download: ML003739257 (46) | |
U.S. NUCLEAR REGULATORY COMMISSION February 1995 REGULATORY GUIDE
OFFICE OF NUCLEAR REGULATORY RESEARCH
REGULATORY GUIDE 6.9 (Draft was Issued as DG-6002)
ESTABLISHING QUALITY ASSURANCE PROGRAMS FOR
THE MANUFACTURE AND DISTRIBUTION OF SEALED SOURCES
AND DEVICES CONTAINING BYPRODUCT MATERIAL
A. INTRODUCTION
satisfy international guidance and a OC program that meets NRC regulations. The NRC was requested. and In 10 CFR Part 32, "Specific Domestic Licenses agreed, to provide specific guidance on the essential To Manufacture or Transfer Certain Items Containing elements needed to develop, establish, and maintain a Byproduct Material, 3 10 CFR 32.210(c) requires QA program that will encompass the QC requirements applicants for registration of sealed sources or devices of 10 CFR Part 32. This regulatory guide provides to submit information about the quality control (QC) guidance on QA programs that are acceptable to the program that the product will be manufactured under, NRC staff for registrants of sealed sources or devices, and 10 CFR 32.210(0 requires the registrant to man other persons licensed pursuant to Part 32, and appli ufacture and distribute the product in accordance with cants for such registration and licenses.
the statements and representations of the QC program.
Appendix A of this guide contains a checklist that In addition, other sections of Part 32 (for example, 10 CFR 32.25 and 32.29) require applicants to manufac may be used as an aid in auditing a QA program.
ture and distribute products in accordance with QC
Appendix B provides some examples of records and standards approved by the U.S. Nuclear Regulatory documentation for a QA progra
m. Appendix C
Commission (NRC). describes the minimum quality controls that must be implemented by persons licensed to manufacture or distribute certain products to persons exempt from Many manufacturers and distributors of sealed licensing.
sources and devices find that marketing considerations make It very desirable for them to be qualified in ac This regulatory guide proposes information collec cordance with international industry consensus stan tions that are subject to the Paperwork Reduction Act dards. These documents provide information and of 1980 (44 U.S.C. 3501 et seq.). This regulatory guidance on acceptable quality assurance (QA) stan guide has been submitted to the Office of Management dards that is broader in concept than the QC require and Budget for review and approval of the information ments in the NRC regulations cited above. The sealed collections.
source and device manufacturers and distributors do not want to develop and implement two different (and The public reporting burden for this collection of in many cases redundant) programs, a QA program to information is estimated to average 160 hours0.00185 days <br />0.0444 hours <br />2.645503e-4 weeks <br />6.088e-5 months <br /> per IJSNRC REGULATORY GUIDES The guldes am Issued In the following ton broad divisions:
Regulatory Guides are Issued to describe and make available to the public such Information as methods acceptable to the NRC staff for Implement 1. Power Reactors
6. Products
7. Transportation Ing specific parts of the Commisslon's regulations, techrnques used by 2. Research and Test Reactors
8. Occupat=oal Health the staff In evaluating specific problems or postulated accidents, and 3. Fuels and Materials Facilities a. Antitrust and Financial Review data needed by the NRC staff In Its revew of applications for permits and 4. Environmental and siting
10. General licenses. Regulatory Guides are not substitutes for regulations, and com 6. Materials and Plant Protection plan*e wi them Is not required. Methods and solutions different ftor set out In the guides will be acceptable If they provide a bas.i orthe findings requisite to the Issuance or continuance o a perm or license by Copies of Issued guides may be purchased from the Govermnent Printing the Commission. Office at the current GPO price. Information an otxrent GPO prices may be obtained by contacting the Superintendent of Documents, U.S.
This guide was Issued after consideration of comments received from the Government Printing Office, Malil Stop SSOP. Washington, DO
public. Connents and suggestions for Impronts In these guides are 20402-03, telephone (2)512-2240.
enc= a=ed at all times, and guies wil be rev sed, as appropriate, to dte comrnents and to reflect new Irnfrmation or experience.
Issued guides may also be purchased from the National Techn.ical WIfr Written comments may be submitted to the Rules Review and Directives mation Service on a standing order basis. Details on this service may be Branch, DFPS, ADM, U.S. Nuclear Regulatory Commission, Washing obtained by writing NTIS. 6285 Port Royal Road, Springfield, VA 22161.
ton, 0620555-0001.
response, including the time for reviewing instructions, QA Director-Person in upper management who searching exdsting data sources, gathering and main does not have direct responsibility for production of a taining the data needed, and completing and reviewing device but is responsible for ensuring that the QA
the collection of information. Send comments regard program is established and maintained.
ing this burden estimate or any other aspect of this collection of information, including suggestions for re QA Manager-Person responsible for ensuring ducing the burden, to the Information and Records that an appropriate QA program is running properly Management Branch (T-6F33), U.S. Nuclear Regula and verifying that the activities affecting device quality have been correctly performed.
tory Commission, Washington, DC 20555-0001, and to the Desk Officer, Office of Information and Regula QA Program-The planned and systematic tory Affairs, NEOB-3019 (3150-0001), Office of actions necessary to provide confidence that a firm or Management and Budget, Washington, DC 20503. product will meet the required specifications. The pro gram must.provide a means to control and measure
B. DISCUSSION
characteristics of an item, process, or facility to the es tablished requirements of the program.
The QA program is intended to provide control over those activities applicable to the design, fabrica Quality Control-Actions taken to prevent or tion, inspection, testing, maintenance, repair, modifi detect product deficiencies.
cation, and distribution of the sealed sources or de Redistributor-Any person, persons, or company vices that contain byproduct material; such a QA licensed to redistribute completed devices or sealed program is necessary to ensure compliance with the sources that have been registered with NRC by the representations made in the registration or license initial distributor.
application or with the regulations.
Repair-Fixing an unacceptable item by a means The following definitions apply for terms used in different than that specified in the production proce this regulatory guide: dures (as opposed to reworking an item).
Applicant-Any person, persons, or company Rework-Fixing an unacceptable item by methods licensed or applying for a license to manufacture, dis included in an approved procedure.
tribute, or redistribute devices. Sample-One or more units of product drawn Deviation-A departure from the specifications from a lot or batch,* the units of the sample being for a device, or a departure from the information drawn without regard to their quality.
supplied to NRC pertaining to the device. Sample Size-The number of units of product in the sample selected for inspection.
Device-Any product (e.g., gauge, sealed source), registered in accordance with 10 CFR 32.210, Service-Any operation pertaining to production that is manufactured, distributed, or redistributed by of the device or operation performed on any part of the applicant. the device.
Document-Any drawing, procedure, instruction, Specifications-Requirements imposed by the or record pertaining to the production of the device. applicant, customer, or NRC that, if not followed, may affect the use or operation of the device.
Material-Any item that is raw material, subas Supplier-Any person, persons, or company that sembly, or a component used in the production of the supplies material, equipment, or service to an device.
applicant.
NRC Contact-The person identified by the licensee as being responsible for ensuring compliance
C. REGULATORY POSITION
with NRC regulations. Applicants for product registrations in accordance Operational Check-A test or set of tests per with 10 CFR 32.210 or for licenses to manufacture, formed on a completed device to ensure that the distribute, or redistribute sealed sources or devices are device operates in its intended manner and to its in required to submit information pertaining to their QC
tended specifications. This includes verification of program to the NRC, for approval, as part of the appli shutter operation, emergency stops, and device safety cation for the product registration or for a license. If features. the OC program is part of a broader QA program, the information submitted should be in the form of a man Production -The process of assembling or fabri ual that defines each component of the QA program.
cating a device or any part of a device. Production The information should be submitted as a supplement includes all operations associated with a device or any to the application described in Regulatory Guides part of a device from the time it is received from a 10.10, "Guide for the Preparation of Applications for supplier until it is distributed to the customer. Radiation Safety Evaluation and Registration of
6.9-2
Devices Containing Byproduct Material," and 10.11, implements each of the 13 components listed in this
"Guide for the Preparation of Applications for Radi section as meeting this guidance. The 13 components ation Safety Evaluation and Registration of Sealed may be part of a QA program that is designed and in Sources Containing Byproduct Material." This docu tended to meet another established standard or ment provides guidance on preparing applications for requirement, including programs established to meet radiation safety evaluation and registration of devices International Organization of Standardization or the and sealed sources containing byproduct material. American National Standards Institute QA program Registrants or licensees who make changes to their QA standards, military standards, requirements or regula programs that require changes to their QA manual are tions established by other U.S. Government agencies to submit applications for amendments to their product (such as the Food and Drug Administration). Howev registration or license. er, the QA program should cover the manufacture and distribution of the products registered in accordance Establishing the QA program implies that all activi with 10 CFR 32.210.
ties that ensure the sealed source or device is manufac tured and distributed in accordance with the
1. ORGANIZATION
statements and representations included in the regis The applicant's organizational structure, function tration and license application and the requirements al responsibilities, and levels of authority should be prescribed in the regulations are implemented. All ac documented, starting with the Chief Executive Officer tivities applicable to the design, fabrication, inspec or equivalent, down to, at a minimum, the head of tion, testing, maintenance, repair, modification, and distribution are to have written procedures approved each department. Each person's responsibilities should be listed. All personnel in the QA department by appropriate levels of management and be contained should be listed, along with their responsibilities. The in quality assurance and control manuals.
applicant's NRC contact should be identified.
Proprietary information (i.e., information not to The QA Manager should report directly to the QA
be disclosed to the public) should not be submitted Director. The QA Director should have continued in unless it is the only means to adequately describe the volvement in ensuring that the QA department is run QA program. If the QA manual contains information ning properly. The QA Director and the QA Manager that the company considers to be proprietary, the in should have the authority, access to work areas, and formation should be clearly marked for appropriate organizational freedom to identify quality problems, handling by NRC. In addition, the letter transmitting recommend or initiate solutions, verify implementa the application or manual should contain a request for tion of solutions, and halt production at any time to
.- withholding from public disclosure as discussed in ensure that the device or production procedures con paragraph 2.790(b) of NRC's regulations in 10 CFR form to all regulations and specifications.
Part 2, "Rules of Practice for Domestic Licensing Pro ceedings and Issuance of Orders." It is essential that 1.1 The organizational structure should be docu these procedures be followed so that the NRC can rec mented in the form of a flow chart, with a brief ognize that a request for withholding is being made and explanation of each position and the responsibili then consider the request on its merits. ties associated with the position. Position titles may be used in the flo* chart in lieu of the names Unless a formal request for withholding has been of the persons occupying the positions.
filed and properly supported with information required under 10 CFR 2.790, statements that manuals or doc 1.2 In a small organization, the company president uments are "confidential," "restricted," or "are to be should be the QA Director, or the QA Director the express property of Company X" should be re should report directly to the company president.
moved from all submittals, or a statement should be This may not be possible in larger organizations.
made that the notes are to be disregarded. In larger organizations, the QA Director should be a person in upper management who does not A QA program should contain, at a minimum, the have direct responsibility for production. This following components to be approved by the NRC helps to ensure that quality is measured against staff. Each component contains a general description the device specifications and not against other of the component, followed by additional, more pre factors, such as production schedules.
scriptive information that applicants may find useful in developing a QA program. The additional information 1.3 The QA Manager should be responsible for the within each section is intended to provide specific everyday workings of the QA program and methods for meeting each component. should be responsible for reviewing and approv ing all changes to, or changes affecting, the QA
The methods given here for each component are program.
not the only methods for developing a QA program that would be acceptable to the NRC staff. The NRC 1.4 Involvement by the QA Director should, at a staff will consider a QA program that establishes and minimum, consist of reviewing the audits of the
6.9-3
QA program and periodically reviewing any 2.6 A sample of an employee training form is In updates, changes, problems, or concerns with cluded on page B-2 of Appendix B.
the QA program. The QA Director should initi ate changes to the QA program as deemed
3. EQUIPMENT
necessary.
All equipment used for measuring' testing, or in specting should be controlled, calibrated, and
2. PERSONNEL maintained. The applicant should have records of all The applicant should have written procedures to repairs and calibrations of the equipment used for ensure that persons have appropriate qualifications measuring, testing, or inspecting.
and training for the jobs they are performing. The All calibrations should be traceable to the Nation applicant should keep records of each employee's edu al Institute of Standards and Technology (NIST) or a cation, experience, training, indoctrinations on the competent national authority. The calibration frequen technical obligations and requirements of his or her cy should be dependent on the equipment's stability, job, and either examination results or capability dem purpose, and degree of usage and should be left to the onstrations, including re-evaluations. The records discretion of the QA Manager. No calibration interval should also provide verification that an employee is should exceed I calendar year.
qualified to perform special procedures or testing (e.g., welding, heat treating, weld inspections). All new equipment or equipment that has under gone maintenance that affects the accuracy of the The applicant should have written procedures for equipment should be calibrated before use.
all training and indoctrinations.
3.1 The applicant should have a historical log for
2.1 Training of personnel may be formal, including a each piece of equipment that is used in the pro written outline of the training with a written or duction of the device, enhances the quality of the hands-on objective examination, or informal, device, or ensures that all specifications and including on-the-job training that includes a regulations are met. The log should include the qualitative determination of the trainee's ability. manufacturer of the equipment, the model num Both formal and informal training should be ber, serial number, and instructions for use. The documented. log should contain records of routine or unsched uled maintenance of all equipment and contain maintenance procedures, nature of the mainte
2.2 All employees should be subject to an initial eval nance performed, date maintenance was per uation of their skills and re-examination on an formed, date equipment is due for maintenance, annual basis. The evaluation may be statistical and the frequency of the maintenance.
analysis of inspection results of work performed by the employee or observation of the em 3.2 Records of calibrations should be kept in the log ployee's work habits and skills, to ensure com for each piece of equipment that includes the pliance with the appropriate specifications. All manufacturer, model number, serial number, evaluations and re-evaluations should be calibration procedures, frequency of calibration, documented. date calibrated, date due for calibration, and a list of persons qualified to calibrate the equip
2.3 The applicant should have a list of employees ment.
qualified to perform each operation. This maybe achieved by maintaining a list of all persons qual 3.3 Equipment and calibration logs should be kept ified to perform an operation, or each em on a computer or hard card system. To ensure ployee's training and qualification file may list that uncalibrated equipment is not used, the sys the operations the employee is qualified to per tem should flag equipment that is nearing its due form. The employee's supervisor should have ac date for calibration.
cess to this information to verify the employee's qualifications. 3.4 AU calibration cycles should be 1 year or less.
The applicant may decide that the calibration
2.4 Each employee's training and qualification file cycle should exceed 1 year for specific equip should include all necessary medical records that ment that is expensive to calibrate and is not may affect the employee's job performance. likely to be out of calibration..
One example is that welders and inspectors may 3.5 Each piece of calibrated equipment should be be required to have their vision tested annually. traceable to its calibration record. Each piece of calibrated equipment should also be marked with
2.5 The applicant should have a list of all employees its calibration date, date calibration is due, and qualified to perform special processes, testing, or the person or company who performed the cali inspections (e.g., welding, heat treating, weld in bration. If it is impractical for the equipment spection). itself to carry such a label, its case should be
6.9-4
labeled and the equipment should be traceable this is to have a controlled list of recipients of the to its case. documents and have each recipient sign off that the most current document was received and is
3.6 If calibration Is performed by a supplier, a record being used.
of calibration from the supplier stating the date
4.2 As soon as a document is revised, approved, and of calibration should be included in the calibra tion file. Suppliers performing calibrations effective, the applicant should ensure that all should demonstrate that all calibrations are previous copies of the document are pulled from production or ensure that the documents are not traceable to NIST or a competent national au being used for production.
thority and should be audited like all other
.suppliers.
4.3 The applicant should ensure that the master co pies of the documents are controlled so that no
3.7 If any equipment has special procedures for han previous revisions of the documents are issued or dling or storage, the equipment should be la used.
beled or its case should be labeled with these pro cedures. If it is not possible to attach the 4.4 The applicant should have a list that reflects all procedure to the equipment or its case, the pro current documents and their appropriate revi cedure should be on file and a label specifying sions. Documents currently being revised should where to find the procedures should be attached be noted on the list.
to the equipment or its case.
4.5 To ensure that all documents are complete and
3.8 A sample page from an equipment log and sam accurate, each document should be reviewed ples of calibration labels are included on pages and approved by someone of equal or greater B-3 and B-4 of Appendix B. proficiency. The reviewer should sign the docu ment to show approval. Other affected depart
4. DESIGN AND DOCUMENT CONTROL ments, such as QA and production, should review the document before releas
e. The NRC
The applicant should have written procedures to contact should review and approve all document ensure that all documents conform to the appropriate revisions if the document was submitted as part specifications and pertinent regulations. The proce of the device registration or license application.
dures should ensure that the documents include all The NRC contact should halt issuance of the special instructions for labeling, cleaning, handling, document if NRC approval is required.
equipment settings, packaging, and storage, as well as special procedures, a list of all materials, all dimen 4.6 A file should be kept for each document. The sions with tolerances, and any special finishes that file should include all previous revisions of the need to be applied. The procedures should ensure that document, all changes to the document, the rea sons for the changes to the document, and all the correct documents, reflecting all drawing changes persons who have received controlled copies of and the correct revision level, are employed. the document.
The procedures should ensure that each docu ment is released only after it has been reviewed and 4.7 Procedures for reviewing the documents should approved by someone other than the person who pre include a checklist of the types of items that pared that document. The procedures should also en should be included in the documents. If any item on the checklist is missing, the reviewer should sure that any changes to the documents are controlled ensure that it was not inadvertently excluded by measures commensurate with those applied to the from the document.
original document and are conveyed to all appropriate departments. Minor changes, such as insignificant edi 4.8 If the applicant is a redistributor, the applicant torial corrections, are not required to undergo the may not need to approve all document changes.
same review and approval process as the original docu However, the applicant should receive copies of ment. Any design or production changes that are dif all document changes.
ferent from those approved by a regulatory agency must be submitted to the appropriate regulatory 4.9 If the applicant is a distributor of devices com agency, for approval, before implementation. pletely manufactured by persons who are not NRC licensees, the applicant should adopt a pro Records of all appropriate documents should be gram that ensures that all document revisions are kept. The records should contain design and docu reviewed and approved if the document was sub ment changes and the reasons for the changes. mitted as part of the device registration or license application. The applicant should halt issuance
4.1 The applicant should ensure that all appropriate of the document if NRC approval is required.
documents used in the production of the device The program should ensure that the applicant re are up to date. One mechanism to accomplish ceives copies of all document changes.
6.9-5
4.10 Samples of an engineering change request, an 5.3 The applicant should develop a qualified supplier engineering change notice, and a drawing issue list. The list should include all suppliers who have checklist are included on pages B-5, B-6, and demonstrated that they are capable of supplying B-7 of Appendix B. the materials or services to the applicant. The applicant should then procure materials or serv
5. MATERIAL AND SERVICE ices only from suppliers on the qualified supplier PROCUREMENT list. The qualified supplier list should be con trolled so that no unqualified suppliers are All materials and procedures used to produce the included on the list.
device must meet specifications and pertinent regula tions. Procurement of materials or services must be 5.4 In lieu of forwarding all the relevant information controlled to ensure conformance with specifications. to the supplier each time an order is placed, the applicant may initiate a written contract with a Suppliers should demonstrate that they are capa supplier. The contract should contain the rele ble of supplying material or services in accordance with vant information. If the applicant has a contract the requirements and specifications. with the supplier, the applicant should ensure that the supplier has copies of, and is using, the Inspections should be performed on all items re most current documents pertaining to the order.
ceived from suppliers upon receipt. The extent of re ceipt inspection should depend on the supplier and 5.5 If the applicant is a redistributor or a distnrbutor should be left to the discretion of the QA Manager. of devices that are not completely manufactured by NRC licensees, the applicant must ensure that Before issuance of an order for materials or serv an operational check is performed on 100 per ices, the applicant should provide to the supplier the cent of the devices and inspect, to the extent pos scope of the work, technical requirements, identifica sible, 100 percent of the devices to ensure that tion of the documents that should accompany the ma they meet their design specifications.
terial or service, identification of the documents that 5.6 Samples of a purchase requisition and a purchase the supplier should keep on file, requirements for re order are included on pages B-8 and B-9 of porting and approving dispositions of nonconfor Appendix B.
mances, and the signature of an authorized purchasing agen
t.
6. INVENTORY
The applicant should have written procedures for, The applicant should have written inventory pro and records of, procurement of materials or services cedures that include procedures for special handling, and inspection upon their receipt. marking, tagging, labeling, segregating, recordkeeping, and handling of nonconforming materia
l. The invento
5.1 Selection of a supplier should be based on the ry procedures should account for material that has a supplier's past history of providing identical or shelf life and ensure that the proper materials are used similar materials or services and the supplier's in the production process.
technical capability, as determined by direct The inventory procedures should include provi evaluation of the facility or by analysis of the sions for in-process material and finished devices. The quality of previously supplied materials or serv ices. If the quality of the product cannot be de procedures should ensure that only items that have termined through inspection or testing, the selec passed inspection are used in the production process, tion of a supplier should be based on the results and that completed devices have passed their final in of an audit of the supplier's operations. spections and testing before distribution.
6.1 All inventory that has a shelf life, such as adhe
5.2 For each supplier, the level of receipt inspection sives and gaskets, should be used on a first-in/
should be based on past performance and the first-out basis, and the inventory system must be results of audits of the supplier's operations. In controlled so that items that have exceeded their spections on receipt may range from inspection shelf life are not used. This may be achieved by of 100 percent of the materials or services marking the containers with the expiration date received from new, nonaudited suppliers to of the material.
inspection of a sample, based on an accepted sampling plan, of the materials or services 6.2 Handling and inventory procedures should en received from audited suppliers with good past sure that materials or devices that are segregated performance. The sample sizes should be in or identified as complete have passed their final creased if the quality of the materials or services inspections and tests. This may be achieved by received decreases. The decrease may be seen having the inspector mark or tag the product as from the trend analysis performed on the inspec having been inspected, or by having the invento tion records or from the audits of the supplier's ry area controlled and only having items that operations. have passed inspection enter the controlled area.
6.9-6
6.3 To ensure that the correct materials are used in persons and is not performing repairs or rework production and that the items have passed their to nonconforming devices, the applicant's pro inspection, the applicant may have a staging area duction procedures may only include inspection, in which all materials needed for production are testing, and distribution procedures. If the brought together by inventory personnel. The applicant performs repairs or rework, the appli inventory personnel should verify that the cor cant should adopt appropriate maintenance rect materials are used and that they have passed procedures.
their inspection.
7.6 An example of an inspection traveler is on page
6.4 Inventory items should be clearly marked or seg B-II of Appendix B, and samples of a fabrica regated to prevent use of the wrong materials. tion flow chart and a logic chart for preparing an Materials that are so similar that they may be inspection traveler are on pages B-15 and B-16 confused with other materials (e.g., different al of Appendix B.
loys of steel, similar size springs) should not be located next to each other. 8. INSPECTION AND TESTING
7. PRODUCTION PROCEDURES AND The applicant must ensure that all materials, de vices, and production procedures conform to the ap PROCESSES propriate specifications and regulations. The applicant The applicant should have written procedures for should have written procedures for in-process inspec all production processes. The procedures should tion and testing of materials, production processes, include all necessary instructions, including the ma and final inspection and testing of the device. The pro chinery, equipment, and qualifications of the worker cedures should include acceptance criteria and proce needed to perform the task. The procedures should dures for receipt inspection, generating sample sizes, also include inspection or testing hold points. Not all final inspection and testing, packaging and transporta tasks need to be listed in the procedures. For example, tion' inspections, and audits of production procedures.
procedures for cutting stock material to length may not The inspection should be performed by someone other need to be listed in the procedures. than the person who performed the work being in spected.
7.1 Production procedures should be adequate for The procedures should also include an inspection the operation to be performed. They may be as simple as a detailed engineering drawing of the schedule that includes mandatory hold points beyond part or device, with notes indicating any special which work should not proceed without successful instructions, cautions, or methods of construc completion of the inspection or test. The procedures tion. More detailed, step-by-step written proce should include provisions for bypassing inspections or dures may be necessary for some complicated tests and provisions for nonconforming materials.
operations. Records should be maintained of all inspections and tests results and should include the date and person
7.2 Production procedures should include appropri performing the inspection or test.
ate hold points. These may be detailed as part of the production procedure or indicated as a note The applicant should have a means of segregating on the production drawing. items that have passed inspection or testing.
7.3 The applicant should specify the flow of materi 8.1 Procedures used to generate sample sizes should als and processes in the form of a flow chart or a be based on industry standards.
traveler that accompanies the item (see example on page B-11). Inspection hold points should be 8.2 Hold points may be specified on a traveler that included in the flow chart or traveler. follows the device through the production proc ess. The traveler would indicate the hold points
7.4 As necessary, the procedures should specify the and the types of inspections or tests to be per qualifications of the workers needed to perform formed. The traveler may be designed to be a each operation. This may be accomplished by record indicating that the inspections or tests classifying workers to certain skill levels, such as have been performed. The traveler should be ap classes of machinists, welders, or inspectors. If proved by QC personnel indicating that the in the worker's qualifications are not identified in spection hold points are acceptable.
the production procedures, the production de partment should have a mechanism to ensure 8.3 In-process inspection of some materials may be that the worker performing the task is qualified performed by sampling. However, 100 percent to perform the task and to operate the equip of materials critical to safety should be inspected.
ment needed to perform the task. The inspection may be sufficient if the materials and construction are verified as part of the
7.5 If the applicant is a redistributor or a distributor operational check of the device. Materials criti of devices completely manufactured by other cal to safety include any item that, if not
6.9-7
manufactured in accordance with its specifica nonconforming materials found through receipt in tions, could by itself (i.e., in the absence of a spection, in-process and final inspection and testing, failure of another component of the device) lead and devices returned by customers. The procedures to an exposure higher than expected during nor should include identification of the nonconforming mal use, handling, or storage of the device. materials, disposition procedures, and provisions for
8.4 As part of the final inspection of the devices, returning reworked items back to production. Before NRC licenses require an operational check and a nonconforming materials are returned to production test for removable contamination on 100 percent or distributed, they should pass all appropriate inspec of the devices before distribution. tions and tests. The applicant should keep records of all nonconformances and their disposition.
8.5 After the inspections, the acceptable items should be tagged, marked, stamped, or segre 9.1 Nonconforming materials should either be segre gated from unacceptable items. A number of gated in a controlled area or be marked as methods may be used to achieve this. Segrega nonconforming.
tion of items may be achieved by physically pass ing the items to the next worker, indicating 9.2 Rework may be performed without prior approv successful completion of the inspection, or by al. However, repair to material should not be having the items placed in a controlled stock performed without appropriate approval.
room or holding area.
9.3 Records of all nonconforming materials should
8.6 Inspection of production processes should follow be kept for trend analysis and for verification a checklist that lists the acceptance criteria. that the materials have not been used in the pro Some inspections may be performed by qualified duction process.
production staff instead of the QC department.
However, the QC department should inspect the 9.4 A traveler form should be used to identify non processes at least yearly. All inspections should conformances. The traveler should indicate the be documented. inspections and approvals needed. The QA and engineering departments should approve the dis
8.7 If a production process is found to be insuffi position of nonconformances.
cient, the inspection results and their impact on previously manufactured products should be 9.5 If the applicant is a redistributor or a distributor evaluated by the QA, engineering, manufactur of devices completely manufactured by persons who are not NRC licensees, the applicant should ing, and other appropriate departments. Appro priate corrective actions should be taken. have procedures indicating the disposition of K
nonconforming materials, including who is re
8.8 Manufacturers and distributors of smoke detec sponsible for repair or rework.
tors and sources used in smoke detectors should adopt inspection and testing programs that meet 9.6 Samples of a Nonconforming Materials Report the "QC Program Specifications for the Man and nonconforming material tags are included ufacture and Distribution of Smoke Detectors" on pages B-13 and B-14 of Appendix B.
in Appendix C. Manufacturers and distributors of other products distributed to persons exempt 10. PACKAGING AND TRANSPORTATION
from licensing should adopt the same inspection The applicant should have written procedures to and testing requirements. ensure that all materials or devices shipped by the applicant are packaged and transported according to
8.9 If the applicant is a redistributor or a distributor the regulations and specifications governing the mate of devices completely manufacturid by persons who are not NRC licensees, the applicant should rial. The procedures should include provisions for in subject each device to final inspection and an op spections of packaging and transportation. The pack erational check before distribution. aging and transportation should have no adverse effect on the material or device.
8.10 Samples of a daily incoming inspection report, The procedures should also have provisions to en an inspection traveler, and a verification of con sure that appropriate paperwork or manuals (instruc formance form are included on pages 10, 11, tions, maintenance procedures, packing list, operation and 12 of Appendix B. manuals, etc.) accompany the device.
9. NONCONFORMING MATERIALS Records should be kept of all packaging and ship ping reports and inspections.
The applicant should have written procedures to ensure that materials and devices that do not conform 10. 1 The applicant should have either a standard pro to the specifications are not used in production or dis tributed. The procedures should have provisions for cedure for packaging all items leaving the facility K
or a unique packaging procedure for each Item as
6.9-8
it leaves the facility. The packaging procedure trends arising should be investigated for possible should include the form of transportation (e.g., generic problems.
name or type of transportation company, picked up by customer) and the labeling of the 11.3 The applicant should have written procedures for packaging. contacting affected customers and procedures for determining whether customers are affected by a failure or complaint. If it appears that the
10.2 Before distribution of any material or device, it failure or complaint is a result of a generic design should be verified that all items, including paper or manufacturing problem, all known users of a work, are included with the material or device or device that may have the same failure should be are being shipped separately. The customer notified. The procedures should ensure that the should be notified if items are missing and that NRC is notified of failures or generic design or they will be sent at a later date. The system manufacturing problems that may be related to should ensure that back-ordered items are sent their license or registration of the product.
when they become available.
11.4 The department responsible for the deviation
10.3 If the applicant is a redistributor or a distributor should be notified as soon as practicable to pre of devices completely manufactured by persons vent additional deviations.
who are not NRC licensees, the device may be shipped from the manufacturer or initial distribu 11.5 A sample customer complaint form is included tor to the customer, and therefore packaging and on pages B-17 and B-18 of Appendix B.
transportation procedures may not be necessary.
If the device is shipped from the applicant's facil 1
2. AUDITS
ity, the applicant should have procedures for packaging and transportation of devices. The applicant should have written procedures for auditing and evaluating its QA program and for audit ing its suppliers. Audits should ensure that the program
11. DEVIATIONS AND CUSTOMER encompasses all the requirements of the applicable COMPLAINTS
regulations. Audit procedures should include accep The applicant should have written procedures for tance criteria and assurance that all procedures are up evaluating and recording deviations, whether reported to date.
by customers or suppliers or found through inspections The person performing audits should have no re or customer complaints, either by telephone or in writ sponsibility for the matters being audited.
ten form. The procedures must adequately address the evaluation and notification requirements listed in 10 Records of all audits should be kept on file and CFR 21.21. Records should be kept of each deviation reviewed by the personnel responsible for the matters or complaint that the applicant receives. The records being audited. Audit records should indicate deficient should contain the device type and model number, se areas in the program and corrective actions. Follow-up rial number (if applicable), name of complainant, na actions should be taken to verify that corrective actions ture and date of the complaint, reply to complainant, are accomplished. All records should be signed and corrective action taken, and root cause of the failure If dated by the appropriate company officer.
known. The procedures should ensure that the QA Internal audits should be performed at intervals Manager and the department that was responsible for not to exceed 1 year. The frequency of audits of the failure are notified of the deviation or complaint suppliers should be left to the discretion of the QA
and the corrective action. All known customers that Manager, but the interval between audits should not may be affected by the failure or complaint should be exceed 3 years.
instructed to take appropriate corrective action.
12.1 The applicant should have standard written pro Trend analysis should be performed on all devi cedures for auditing its QA program and for au ations. The analysis should be on-going and be per diting its suppliers. A written checklist specifying formed at least yearly. the necessary components of the QA program should be completed as a record of the audit.
11.1 The applicant should have a log of complaints received from customers by phone or in writing. 12.2 The completed audit checklist should include the The log should include: device type and model signature of the auditor, signature of the person number, serial number, name of complainant, responsible for the area being audited, and the nature and date of the complaint, reply to com date of the audit. If the audit reveals deficient plainant, corrective action taken, and root cause areas of the program, the deficient areas should of the failure, if known. be noted on the checklist, and the deficient areas should be re-audited. The auditor should again
11.2 Trend analysis should be, at a minimum, by type sign the checklist when all deficiencies have been of failure and model number of the device. Any corrected. If the deficiencies are minor, the
6.9-9
auditor may allow. them to be corrected before inspection or audit has been performed, or it completion of the audit or may agree with the may include the actual values identified during corrective action to be taken. In these cases a the inspection. More detailed records may be re-audit is not necessary. necessary if past performance has been below acceptable levels. Analysis of the records may In
12.3 If audits are used to verify employees' perform dicate procedural or design weaknesses.
ance, the procedure for the audits should specify K.
the acceptance criteria for the job being per 13.2 Records of audits and inspections and all neces formed. A record of the audit should be kept. sary documentation should be available to the necessary departments.
12.4 In small companies, it may not be possible for the auditor to have no responsibility for the matters 13.3 The QA Department should have access to the being audited. If this is the case, the applicant master copies of all records and documentation.
should consider having some of the audits per formed by outside auditors. 13.4 Samples of records and documentation for QA
programs are included in Appendix B. Appendix
12.5 If the applicant is a distributor of devices com B is not an all-inclusive listing of records and pletely manufactured by persons who are not documents. The records and documents are for NRC licensees, it is extremely Important that the guidance only, and applicants are not required to applicant perform frequent detailed audits of the have identical documents and records. Appli manufacturer's operations. cants should have documents and records tai lored to their own programs.
13. RECORDS AND DOCUMENTATION
D. IMPLEMENTATION
The QA Department should ensure that all appro The purpose of this section is to provide informa priate pertinent records are maintained and filed. This tion to applicants or licensees regarding the NRC
includes the results of tests, inspections, and audits, as staff's plans for using this regulatory guide.
well as copies of up-to-date written procedures. The objective is to ensure that each component of the QA Except In those cases in which an applicant or li program has been properly implemented. The records censee proposes an acceptable alternative method for should be accessible to each appropriate regulatory complying with specified portions of the Commission's agency and should be kept for the useful life of the regulations, the method described in this guide reflect device. ing public comments will be used In the evaluation of
(1) submittals by applicants to establish QA programs
13.1 Records may vary in form and content and are for manufacture, distribution, or redistribution of the dependent on the size of the operation and past sealed sources or devices and (2) registrants' and li performances. The record may consist of as little censees' performance with respect to developing, es as a signed log or checklist indicating that the tablishing, and maintaining such QA programs.
6.9-10
APPENDIX A
CHECKLIST FOR AUDITING QA PROGRAMS
The checklist in this appendix is designed as an aid in auditing an applicant's quality assurance (QA) program. The checklist is designed as an aid and may not be all-inclusive.
In addition, certain items may not be applicable to all applicants.
The checklist is designed to assign different ratings to the adequacy and implementa tion of each component of an applicant's QA program. When auditing QA programs, the following ratings should be assigned to each item listed in the table:
1 Superior
2 Meets the specifications of this document
3 Needs to be improved to meet the specifications of this document
4 Does not exist
5 Not applicable
6 Did not audit A-I
QUESTIONS I RATING*
PROGRAM/IMPLEMENTATION COMMENTS r
1. Does the vendor have a QA manual or set of instructions defining the QA
program?
2. Is the manual up to date?
3. Is the manual approved and signed by a designated official from each department?
ORGANIZATION
4. Is the organizational structure of the applicant documented in the QA
manual?
5. Are all the QA personnel listed, along with all their responsibilities?
6. Is the QA Director someone in upper management not directly responsible for manufacturing or production?
7. Does the QA Director have continual involvement in the QA program?
8. Is the NRC Contact listed and up to date? S
Director have the authority to halt production?
PERSONNEL
Does the applicant have procedures to ensure up-to-date records of:
10. All employees' qualifications?
11. All employees' training?
12. All employees' indoctrinations?
13. All employees' medical records?
14. All training procedures?
15. All indoctrination procedures?
- Ratings: 1-superior; 2-meets specifications; 3-needs improvements;
4-does not exist; S-not applicable; 6-did not audi
t. S
A-2
(QUESTIONS ROGRAMI
RATING*
EMENTATION COMMENTS
16. All employees qualified to perform special procedures or testing?
17. Are items 10 through 16 up to date?
EQUIPMENT
18. Does the applicant have a historical log of all its equipment?
19. Does the log include manufacturer, model and serial number, and instructions for use?
20. Are there procedures for and records of routine and unscheduled maintenance of equipment?
21. Does the applicant have a calibration log that includes:
"*manufacturer?
"*model and serial number?
"*calibration procedures?
- frequency?
"*qualified calibration personnel?
"*date calibrated?
"*date due for calibration?
22. Are all calibrations, either performed by the applicant or a supplier, traceable to the National Institute of Standards and Technology or equivalent?
23. Are all calibration cycles reasonable and less than 1 year?
24. Does the calibration system have a flag to ensure that all equipment is recalibrated before its expiration date?
25. Is all equipment marked with calibration date, due date, and the person who performed the calibration?
26. Is all equipment traceable back to calibration record?
- Ratings: 1-superior; 2-meets specifications; 3-needs improvements;
4-does not exist; 5-not applicable; 6-did not audit.
A-3
RATINGS
QUESTIONS PROGRAMIMEMEATION COMMENTS
27. Where applicable, is equipment labeled with special handling or storage instructions?
28. Is all new equipment or equipment that has undergone maintenance calibrated before use?
DESIGN AND DOCUMENT CONTROL
29. Are there procedures for ensuring that all documents contain all pertinent information and conform to all pertinent regulations and specifications?
30. Are there procedures for handling document and design changes?
31. Do the procedures ensure that all appropriate departments are notified of the changes?
32. Do the procedures ensure that documents under revision are not used?
33. Are all changes documented?
34. Do the procedures ensure the documents and changes are checked and approved before released?
35. Do the procedures include notifying regulatory agencies of any changes?
36. Do the procedures ensure alternative approaches in the absence of specifications?
37. Is there a history file, for each document, that includes previous versions, document changes, and reasons for the changes?
38. Are there copies on file of all up-to date documents for each job?
- Ratings: l-superior, 2-meets specifications; 3-needs improvenents;
4-does not exist; 5-not applicable; 6-did not audit.
A-4
QUESTIONS ____
RATING*
_ A ION
COMMENTS
MATERIAL AND SERVICE
PROCUENN
39. Are there procedures for verification of the adequacy of suppliers?
40. Are there records of all audits of suppliers?
41. Are audits of suppliers performed at intervals less than 3 years?
42. Are there procedures for receipt inspection?
43. Do receipt inspection procedures verify:
- correct sizes?
- quantity?
- document and specification conformance?
- paperwork?
44. Are there procedures for receipt of nonconforming material?
45. Are there records of receipt inspections, including nonconforming material?
46. Do all purchase orders contain:
"*scope of work?
"*technical requirements?
"*identification of the documents that must accompany the order?
"*identification of the records that the applicant must keep?
"*signature of the appropriate individual?
47. Are there records of all purchases?
ORatings: 1-superior; 2-meets specifications; 3-needs improvements;
4-does not exist; S-not applicable; 6-did not audit.
A-5
RATING*
QUESTIONS PROGRMIIMPLMNTATION COMMENTS
INVENTORY
48. Are there inventory procedures?
49. Do inventory procedures include:
"*special handling?
"*marking?
"*tagging?
"*labeling?
"*segregating?
"*paperwork procedures?
"*handling of nonconforming material?
50. Does the inventory system have provisions for material with shelf life?
51. Does the inventory system have provisions to ensure that the correct material is used in production?
52. Are periodic physical inventories performed?
53. Does the system ensure that products that are marked or segregated as complete have passed their final inspections and testing?
PRODUCTION PROCEDURES
AND PROCESSES
54. Are there procedures that describe production processes?
55. Do the procedures include:
" machinery and equipment to be used?
"*qualifications of workers?
"*equipment settings?
"*hold points for inspection and testing?
56. Is there a flowchart describing the flow of material and inspection hold points?
- Ratings: 1-superior; 2-meets specifications; 3-needs improvements; K
4-does not exist; S-not applicable; 6-did not audit.
A-6
QUESTIONS PROGRAMIIMPLEMEENTAITON COMMENTS
INSPECON AND TESTING
57. Are there procedures for in-process and final inspection and testing of the device?
58. Do inspection procedures include:
9 acceptance criteria?
- receipt inspection?
- at what points to perform in process inspections and tests?
- procedures for determining sample sizes?
e procedures for final inspection and testing?
- provisions for nonconformn.g material?
59. Are there procedures for inspections of production procedures?
60. Are there records of all inspections and testing, including date and person performing the inspection or test?
61. Is there a system for marking or segregating items that have been inspected* or tested?
62. Does final inspection include operational check and removable contamination test of 100% of the devices?
NONCONFORMING MATERIALS
63. Are there procedures for handling nonconforming items received from a supplier or customer or found during production?
64. Are nonconforming materials tagged or segregated from production?
- Ratings: 1-superior; 2-meets specifications; 3-needs improvements;
4-does not exist; S-not applicable; 6-did not audit.
A-7
RATING*
QUESTIONS PROGR AMVM MENTAUAON COMMENTS
65. Are there procedures for disposition of nonconforming materials and for introducing materials back into production?
66. Are there records of all nonconforming material?
PACKAGING AND TRANSPORTATION
67. Are there procedures for inspecting packaging and the form of transportation?
68. Do these procedures ensure that all paperwork and manuals are included with the shipment or are being shipped separately to the customer?
69. Are there records of all packaging and shipping reports and inspections?
DEVIATIONS AND
CUSTOMER COMPLAINTS
70. Are there procedures for evaluating deviations and customer complaints?
K
71. Are there procedures for informing the appropriate members of the organization and NRC of deviations?
72. Are there procedures for informing customers of devices that may contain a deviation?
73. Are there records of all deviations and customer complaints?
74. Do customer complaint records contain:
"*name of complainant?
"*nature and date of complaint?
"*corrective action taken?
"*cause of the failure?
"*model and serial number of the device?
- Ratings: 1-superior; 2-meets specifications; 3-needs improvements;
4-does not exist; S-not applicable; 6-did not audit.
A-8
QUESTONS I RATING*
PROGRAMAnLEMETON COMMENTS I,
75. Are there procedures for trend analysis of deviations and complaints?
76. Is trend analysis performed at intervals that do not exceed 1 year?
AUDITS
77. Does the applicant have procedures for auditing its QA program?
78. Do the procedures include acceptance criteria?
79. Do the procedures ensure that all records and procedures are up to date?
80. Do audits include verification of audits of suppliers?
81. Is the auditor responsi'ble for any of the matters being audited?
82. Do records include deficient areas in the program and corrective action taken?
83. Are all deficient areas corrected?
84. Are all records signed and dated by the appropriate member of the organization?
- Ratings: 1-superior 2-meets specifications; 3-needs Improvanents;
4-does not exist; 5-not applicable; 6-did not audit.
A-9
APPENDIX B
EXAMPLES OF RECORDS AND DOCUMENTATION
The following documents are examples of records and documentation for quality assur ance (QA) programs. It is not a complete listing of documents and records for QA pro grams. These samples are for guidance only and are not considered standard formats. The applicant should have documents and records tailored to its program.
B-1
EMPLOYEE TRAINING
Employee:
Department:
Supervisor:
Hire Date:
Training Date:
Training Type:
I, a, have received (employee's name) (type of training)
training on / and understand its content.
(Date)
Employee Signature Trainer Signature B-2
- EQUIPMENT LOG
NAME OF EQUIPMENT:
MODEL NUMBER: _________SERIAL NUMBER:____________
MANUFACTURER:
USED FOR:
INSTRUCTIONS FOR USE, MAINTENANCE, CALIBRATION:
MAINTENANCE FREQUENCY: CALIBRATION FREQUENCY:
PERFORMED
DATE CALI. MAIN. BY COMMENTS
B-3
r"
="
CALIBRATION LABELS:
CALIBRATION
MODEL #:_SERIAL #:
DATE CALIBRATED:
DATE DUE FOR CALIBRATION:
CALIBRATED BY:
OUT OF CALIBRATION j DO NOT USE
I CALIBRATION NOT
REQUIRED
B-4
EMfIRIM(
I
tI-lANE REQUEST ECR#
l.ll..It, 5Itl u vn Sn. --. ... - ..
INITIATOR DEPT. DATE
MODEL/PART NO- CUSTOMER/ORDER NO.
TYPE OF CHANGE
REASON FOR CHANGE
NORMAL
EMERGENCY
DOCUMENT NO. DESCRIPTION OF CHANGE
REVIEWED/APPROVED REMARKS / COMMENTS
DEPT. SIGNATURE DATE
DESIGN
ENG.
PROD.
QA ENG.
PROD.
PLAN.
R&D
OTHER
wrn'IPY SUPPLIER YES NO
NOTIFY CUSTOMER YES NO
NOTIFY NRC YES NO
B-5
. F , I
ENGINEERING CHANGE NOTICE ECN#
FCN#
MODEL/PART NO. CUSTOMER/ORDER NO.
CHANGED BY CHECKED BY DATE
RELEASED
DOCUMENT NO. REV. DESCRIPTION OF CHANGE
UNITS AFFECTED STOCK DISPOSITION
DATE
INVENTORY SCRAP REWORK
FIELD UNITS NEXT RUN DEPLETE OTHER USE
DESCRIPTION OF
IN PROCESS SEE STOCK DISP. OTHER USE:
REMARKS DISTRIBUTION
NOTIFICATION REQUIRED: SUPPLIER CUSTOMER NRC
B-6
DRAWING ISSUE CHECKLIST
TDATE
TO
ORDER NUMBER
FROM
A_
have been sent to you The following drawings and/or documents of since LI . Please review your recent receiptsreceived to whether you have documents and check the column as form this where indicated. Return them or not. Sign and date keep a copy for your the marked original to me immediately and records. NUMB]
DRAWING OR DOCUMENT NUMBER l E'
OR DOCUMENT NUMB] * -ISSUE NUMBER RECID
DRAWING
.1- 4
1 1 i certify that the previous revisions of the documents and I certify that the previous revisions of the documents and for:
drawings have been recalled or accounted Date Signature DATE:
BYI
FIELD CHECKED
B-7 I I
PURCHASE REQUISITION
REQUIsITIONED BY: DEPARTMENT:
PURCHASE REQUISITION
PURCHASE CHANGE
P.O. NUMBER CHANGE NO. DATE DATE DELIVERY
REQUIRED
ORDER DATE DELIVERY DATE
F.O.B. VIA
ITEM
NO.
QUANTITY &
UNITS
PART
NUMBER
SUPPLIER NUMBER &
DESCRIPTION
I
t t I.
I. I.
i i
- 1 I
-I t I t t S--It___
SUPPLIER:
B-8
PURCHASE ORDER NO.
OTEm This purchase order is subject to the provisions on the face hereof and the instructions, terms, and conditions on the reverse side. Please review them carefully. They will constitute our contract unless we agree in writing to changes or additions.
COMPANY NAME
BY:
Authorized Agent B-9
DAILY
INCOMING MATERIALS INSPECTION
REPORT
DATE POP SUPPLIER# PART# TOTAL INSP. REJECT NCMR# BY:
I I I ___________ 1. .1 I. I _______ ________ _______
I* t I* I I. I.
I 1441
1 I * 4 J J
E-l1 B-1O
INSPECTION TRAVELER
JOB I:______ BATCH #:_ ITEM I:
JOB
INSPECTION AND TEST POINTS TO'PERFORM
TO BE PERFORMED INSPECTION/TEST
- INSP./TEST PERFORMED PASS/
DATE PERFORMED BY FAIL COMMENTS
B-11
, I ! I
VERIFICATION OF CONFORMANCE
Date:
Company:
Address:
Purchase Order:
Item/Part Number:
Contract:
This certificate assures that the items listed below conform to all the conditions of Purchase Order (P.O.#) , Contract (contract #) , and their engineering drawings.
ITEM NUMBER PART NUMBER DRAWING NUMBER DESCRIPTION
COMPANY NAME
BY:
SIGNATURE DATE
TITLE
(Witness)
SIGNATURE DATE
B-12
NONCONFORMING MATERIAL REPORT NCMR#
SUPPLIER
PURCHASE ORDER NO. BUYER
INSPECTOR DATE INSPECTED
DATE RECEIVED
DESCRIPTION
LOCATION
T1P1w! DESCRIPTION OF NONCONFORMANCE
Tf I DECRPIO---ONONOMAC
I.
I.
i.
_____________I
QUALITY
AS IS REPAIR/REWORK RETURN TO SUPPLIER SHORTAGE
COMMENTS/REWOR
INSTRUCTIONS:
REWORKED AND RE-INSPECTED:
SIGNATURE DATE
B-13 II
NONCONFORMING MATERIAL TAG:
NONCONFORMING MATERIAL
TYPE: LOT #:
PART #:_SERIAL#_
MATERIAL CANNOT BE USED UNTIL RELEASED BY:
DATE: INSPECTOR:-
B-14
Sealed Source Fabrication Flow Chart B-is
S Establish OA is complex aprpite to Establish requirements for extensive In-process m && e final inspection & test classifications, codes &
n Inscen&iorequre test rquire inn-process Yefna
- > No Estalsh fuinable Proide supplcessntayDsgnoe Sdue to historyN&M"
standa-dzatlon, yDecision Those in-proces & final Inspections & tests presently L llii i ii specified In mnanufacturers or QaA manual fC
B-16
CUSTOMER COMPLAINT FORM
Date: L
Time:
Call Taken By:
Customer Name:
Customer Address:
Contact Name:
Contact Phone #:
Device Model: Device Serial #:
Isotope: Activity: mCi Complaint:
Reply to Complainant:
B-17
CUSTOMER COMPLAINT FORM, Cont.
Corrective Action:
K
Cause of Failure:
List of Customers Affected and Notified:
Actions to be Taken by Affected Customers:
Reviewed by:
(Corporate Officer)
NRC was notified: 1 L
(date)
B-18
APPENDIX C
QUALITY CONTROL PROGRAM SPECIFICATIONS FOR
CERTAIN EXEMPT PRODUCTS
The attached document details the QC specifications for the manufacture and distrbu tion of smoke detectors. The same specifications should be incorporated for the manufac ture and distribution of all devices containing byproduct material that are distributed to persons exempt from licensing.
C-1
QC Program Specifications for the Manufacture and Distribution of Smoke Detectors
10 CFR 32.29 requires an applicant to provide information on an adequate QC program to ensure that each production lot meets the design standards approved by the U.S. Nuclear Regulatory Commission.
The following flowchart and text represent the specifications that have been deemed appropriate for such a program. Applicants are encouraged to use this approach or submit, in detail, an equivalent alternative program.
C-2
0C Program Specifications for the Manufacture and Distribution of Smoke Detectors (Cont'd)
IFOIL SOURCE MAUFACTUER '
5'n FogsOnl yFoilsinFoils oButonIon Chazmber Completed FButton
1) 100% Tested for Removable Contamination
2) Use Lot Tolerance Percent Defective (LTPD)*5% Acceptance Sampling for Conformity to Design Specifications YES NO
I SMOKE DETECTOR MANUFACTURER
I
Ndor to Final Packaging. Pftxto final Pf"
1) 100% Test flor Removable Contaiato 1) LTPO5%sampling to Rmval an Button or Ion Ch'amber ContmiatonanButton or Ion Chamber
2) LTPD*5% Sampling for Design Contormity 2) LTPD*S% Samping for Design 0=nformity DISTRIBUTORI
- LTPD acceptance sampling Is based on ft attached charts.
C-3
.II
OC Program Specifications for the Manufacture and Distribution of Smoke Detectors (Cont'd)
- LTPD acceptance sampling Is based on the attached chauts.
- Based on rellabllity/lnspectabllity of USA fabrication records and facilities.
C-4
Definitions:
1. Acceptance Number (C) means the largest 7. Final Packaging is the packaging in which the unit is contained for sale to the end user.
number of defectives (or defects) in the Also known as market package.
sample or samples under consideration that will permit the acceptance of the inspection 8. Inspection means the process of measuring, lot. examining, testing, gauging, or otherwise comparing the unit with the applicable
2. Acceptance Sampling means inspection requirements.
sampling in which decisions are made to accept or reject product; also, the procedures 9. Lot Tolerance Percent Defective (LTPD) is by which decisions to accept or reject are defined by the American Society for Quality based on the results of the inspection of Control as "... expressed in percentage samples.
defective, the poorest quality in an individual lot that should be accepted."
3. Defect means an instance of a failure to meet a requirement imposed on a unit with respect 10. Quality Characteristics are the test criteria.
to a single quality characteristic. The devices must have less than 185 becquerels (0.005 microcurie) of removable
4. A Defective means a defective unit; a unit of contamination and conform to the product that contains one or more defects manufacturer's design specifications (e.g.,
with respect to the quality dcaracteristic(s) labeling, packaging, construction, etc.). Up under consideration. to 75 units may be tested for removable contamination, using one swip
e. The trigger
5. Design Conformance means a complete unit level for multiple units using one swipe is that has been inspected and has been shown 185 becquerels (0.005 microcurie).
to meet the design specifications that were submitted to and approved by NRC. Design
11. Sample (n) means, in acceptance sampling, specifications include detailed information one or more units of product (where n is the about labeling, point of sale packaging, and detector construction. number of units) drawn from a lot, for purposes of inspection, to reach a decision Disposition of Lot: If any units within a regarding acceptance of the lot.
6.
sample are observed to be defective, the entire lot must either be rejected or 12. Sampling at Random, as commonly used in inspected. All failed units must pass the test acceptance sampling theory, means the criterion before release. process of selecting sample units in such a manner that all units under consideration have the same probability of being selected.
For our purposes, the LTPD tables found in 10 CFR 32.110 and Regulatory Guide 6.6 have been modified, whereby the acceptance number for all lot sizes is zero (0). The reasoning behind this change is that from a health and safety standpoint, no defects in these devices are acceptable. If defective units are found within the sample, the entire lot shall either be rejected, or inspected for conformance to the quality characteristic(s) in which the sample units were found to be defective. All units that are found to be defective must conform to the quality characteristic(s) before release, or be rejected entirely. It is recommended that the choice of samples be as random as possible, to provide the maximum probability that a defect will be detected.
C-5
The following are the modified 3 % LTPD and 5 % LTPD tables:
LTPD = 3%
LOT SIZE In Jc
1-40 All 0
41-55 40 0
56-100 55 0
101-200 65 0
201-500 70 0
501-3000 75 0
3001 - 100,000 130 0
LTPD =5%
LOT SIZE n [
1-30 All 0
31-50 30 0
51-100 37 0
101-200 40 0
201-300 43 0
301-400 44 0
401-2000 45 0
2001 - 100,000 75 0
C-6
Rationale for Specifications:
Foil source suppliers can be divided into three general categories: 1) manufacturers who supply only foil sources; 2) manufacturers who supply foil sources installed in button holders;
j, 3) manufacturers who supply foil sources installed in complete ion chambers. All source manufacturers are required to ensure that each source is tested and meets the requirements for removable contamination, before delivery to the smoke detector manufacturer. Foils installed in buttons and/or completed ion chambers tend to be better protected from abrasion or mishandling.
Accordingly, these sources have a lesser chance than unprotected foil sources of being damaged during installation into a smoke detector. Therefore, smoke detector manufacturers who receive foil sources, only, must additionally test each smoke detector or ion chamber assembled for removable contamination, before the final packaging of the device. Conversely, smoke detectors that are manufactured using a foil source received in a button or a completed ion chamber need only be tested for removable contamination, according to the LTPD=5% table. All smoke detectors, regardless of manufacturer, must be tested for conformance to design specifications, according to the LTPD=5% table. This yields a 95 percent confidence level that the devices meet design specifications.
Before a smoke detector is distributed in the United States, the foil source, button, or ion chamber used in the device must be registered with NRC, according to Regulatory Guide 10.10 or 10.11.
Smoke detector manufacturers can be located inside or outside the United States. NRC cannot always have access to the records of foreign manufacturers, since inspection of the manufacturers is not always possible. The records and facilities of manufacturers and distributors located within the United States are always available for inspection by NRC. Therefore, distributors who receive complete devices from a U.S. manufacturer need not conduct further testing for removable contamination and/or design conformity. This testing is conducted by the manufacturer and can easily be verified. Accordingly, distributors who receive devices from U.S. manufacturers need only check the devices for the appropriate labeling on the point-of-sale packaging, according to the LTPD=5% table.
Since foreign manufacturers cannot easily be inspected, tests for removable contamination and design conformity performed by these manufacturers cannot easily be verified. The distributor must provide assurance that devices received from a foreign manufacturer have been tested for these criteria. This is accomplished by the distributor conducting lot sampling of the devices. If the foreign manufacturer provides a written certification that these tests were performed, as well as providing the results of these tests, then the distributor need only perform lot sampling for these criteria according to the LTPD-5% table. However, if the foreign manufacturer does not provide a certification and the test results, and if the manufacturer received the source in foil form only, then the distributor must perform lot sampling for these criteria, according to the LTPD=3% table.
This yields a 97 percent confidence level that the devices are within removable contamination limits and meet design specifications. The reason the additional level of confidence is needed goes back to the fact of unprotected foil sources being more susceptible'to damage during shipment and installation. If, however, the foreign manufacturer receives the source in a button or a completed ion chamber, from a U.S. manufacturer, then the distributor need only test the devices for removable contamination and design conformance, according to the LTPDf5% table, even if the manufacturer does not provide a certification and test results.
C-7
VALUE/IMPACT STATEMENT
A draft value/impact statement was published with the draft of this guide when it was published for public comment (Task DG-6002, May 1994). No changes were necessary, so a separate value/impact statement for the final guide has not been prepared. A copy of the draft value/impact statement is available for inspection or copying for a fee In the Commis sion's Public Document Room at 2120 L Street NW, Washington, DC, under Task DG-6002. The PDR's mailing address is Mail Stop LL-6, Washington, DC 20555;
telephone (202)634-3273; fax (202)634-3343.
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