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
In 10 CFR Part 32, "Specific Domestic Licenses To Manufacture or Transfer Certain Items Containing Byproduct Material, 3 10 CFR 32.210(c) requires applicants for registration of sealed sources or devices to submit information about the quality control (QC)
program that the product will be manufactured under, and 10 CFR 32.210(0 requires the registrant to man ufacture and distribute the product in accordance with the statements and representations of the QC program.
In addition, other sections of Part 32 (for example, 10
CFR 32.25 and 32.29) require applicants to manufac ture and distribute products in accordance with QC
standards approved by the U.S. Nuclear Regulatory Commission (NRC).
Many manufacturers and distributors of sealed sources and devices find that marketing considerations make It very desirable for them to be qualified in ac cordance with international industry consensus stan dards. These documents provide information and guidance on acceptable quality assurance (QA) stan dards that is broader in concept than the QC require ments in the NRC regulations cited above. The sealed source and device manufacturers and distributors do not want to develop and implement two different (and in many cases redundant) programs, a QA program to IJSNRC REGULATORY GUIDES
Regulatory Guides are Issued to describe and make available to the public such Information as methods acceptable to the NRC staff for Implement Ing specific parts of the Commisslon's regulations, techrnques used by the staff In evaluating specific problems or postulated accidents, and data needed by the NRC staff In Its revew of applications for permits and licenses. Regulatory Guides are not substitutes for regulations, and com 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 the Commission.
This guide was Issued after consideration of comments received from the public. Connents and suggestions for Impronts In these guides are enc= a=ed at all times, and guies wil be rev sed, as appropriate, to dte comrnents and to reflect new Irnfrmation or experience.
Written comments may be submitted to the Rules Review and Directives Branch, DFPS, ADM, U.S. Nuclear Regulatory Commission, Washing ton, 0620555-0001.
satisfy international guidance and a OC program that meets NRC regulations. The NRC was requested. and agreed, to provide specific guidance on the essential elements needed to develop, establish, and maintain a QA program that will encompass the QC requirements of 10 CFR Part 32. This regulatory guide provides guidance on QA programs that are acceptable to the NRC staff for registrants of sealed sources or devices, other persons licensed pursuant to Part 32, and appli cants for such registration and licenses.
Appendix A of this guide contains a checklist that may be used as an aid in auditing a QA program.
Appendix B provides some examples of records and documentation for a QA progra
m. Appendix C
describes the minimum quality controls that must be implemented by persons licensed to manufacture or distribute certain products to persons exempt from licensing.
This regulatory guide proposes information collec tions that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). This regulatory guide has been submitted to the Office of Management and Budget for review and approval of the information collections.
The public reporting burden for this collection of 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 The guldes am Issued In the following ton broad divisions:
1. Power Reactors
2. Research and Test Reactors
3. Fuels and Materials Facilities
4. Environmental and siting
6. Materials and Plant Protection
6. Products
7. Transportation
8. Occupat=oal Health a. Antitrust and Financial Review
10. General Copies of Issued guides may be purchased from the Govermnent Printing Office at the current GPO price. Information an otxrent GPO prices may be obtained by contacting the Superintendent of Documents, U.S.
Government Printing Office, Malil Stop SSOP. Washington, DO
20402-03, telephone (2)512-2240.
Issued guides may also be purchased from the National Techn.ical WIfr mation Service on a standing order basis. Details on this service may be obtained by writing NTIS. 6285 Port Royal Road, Springfield, VA 22161.
response, including the time for reviewing instructions, searching exdsting data sources, gathering and main taining the data needed, and completing and reviewing the collection of information. Send comments regard ing this burden estimate or any other aspect of this collection of information, including suggestions for re ducing the burden, to the Information and Records Management Branch (T-6F33), U.S. Nuclear Regula tory Commission, Washington, DC 20555-0001, and to the Desk Officer, Office of Information and Regula tory Affairs, NEOB-3019 (3150-0001), Office of Management and Budget, Washington, DC 20503.
B. DISCUSSION
The QA program is intended to provide control over those activities applicable to the design, fabrica tion, inspection, testing, maintenance, repair, modifi cation, and distribution of the sealed sources or de vices that contain byproduct material; such a QA
program is necessary to ensure compliance with the representations made in the registration or license application or with the regulations.
The following definitions apply for terms used in this regulatory guide:
Applicant-Any person, persons, or company licensed or applying for a license to manufacture, dis tribute, or redistribute devices.
Deviation-A departure from the specifications for a device, or a departure from the information supplied to NRC pertaining to the device.
Device-Any product (e.g.,
gauge, sealed source), registered in accordance with 10 CFR 32.210,
that is manufactured, distributed, or redistributed by the applicant.
Document-Any drawing, procedure, instruction, or record pertaining to the production of the device.
Material-Any item that is raw material, subas sembly, or a component used in the production of the device.
NRC Contact-The person identified by the licensee as being responsible for ensuring compliance with NRC regulations.
Operational Check-A test or set of tests per formed on a completed device to ensure that the device operates in its intended manner and to its in tended specifications.
This includes verification of shutter operation, emergency stops, and device safety features.
Production -The process of assembling or fabri cating a device or any part of a device. Production includes all operations associated with a device or any part of a device from the time it is received from a supplier until it is distributed to the customer.
QA Director-Person in upper management who does not have direct responsibility for production of a device but is responsible for ensuring that the QA
program is established and maintained.
QA Manager-Person responsible for ensuring that an appropriate QA program is running properly and verifying that the activities affecting device quality have been correctly performed.
QA Program-The planned and systematic actions necessary to provide confidence that a firm or product will meet the required specifications. The pro gram must.provide a means to control and measure characteristics of an item, process, or facility to the es tablished requirements of the program.
Quality Control-Actions taken to prevent or detect product deficiencies.
Redistributor-Any person, persons, or company licensed to redistribute completed devices or sealed sources that have been registered with NRC by the initial distributor.
Repair-Fixing an unacceptable item by a means different than that specified in the production proce dures (as opposed to reworking an item).
Rework-Fixing an unacceptable item by methods included in an approved procedure.
Sample-One or more units of product drawn from a lot or batch,* the units of the sample being drawn without regard to their quality.
Sample Size-The number of units of product in the sample selected for inspection.
Service-Any operation pertaining to production of the device or operation performed on any part of the device.
Specifications-Requirements imposed by the applicant, customer, or NRC that, if not followed, may affect the use or operation of the device.
Supplier-Any person, persons, or company that supplies material, equipment, or service to an applicant.
C. REGULATORY POSITION
Applicants for product registrations in accordance with 10 CFR 32.210 or for licenses to manufacture, distribute, or redistribute sealed sources or devices are required to submit information pertaining to their QC
program to the NRC, for approval, as part of the appli cation for the product registration or for a license. If the OC program is part of a broader QA program, the information submitted should be in the form of a man ual that defines each component of the QA program.
The information should be submitted as a supplement to the application described in Regulatory Guides
10.10, "Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of
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Devices Containing Byproduct Material," and 10.11,
"Guide for the Preparation of Applications for Radi ation Safety Evaluation and Registration of Sealed Sources Containing Byproduct Material." This docu ment provides guidance on preparing applications for radiation safety evaluation and registration of devices and sealed sources containing byproduct material.
Registrants or licensees who make changes to their QA
programs that require changes to their QA manual are to submit applications for amendments to their product registration or license.
Establishing the QA program implies that all activi ties that ensure the sealed source or device is manufac tured and distributed in accordance with the statements and representations included in the regis tration and license application and the requirements prescribed in the regulations are implemented. All ac tivities applicable to the design, fabrication, inspec tion, testing, maintenance, repair, modification, and distribution are to have written procedures approved by appropriate levels of management and be contained in quality assurance and control manuals.
Proprietary information (i.e., information not to be disclosed to the public) should not be submitted unless it is the only means to adequately describe the QA program. If the QA manual contains information that the company considers to be proprietary, the in formation should be clearly marked for appropriate handling by NRC. In addition, the letter transmitting the application or manual should contain a request for
.-
withholding from public disclosure as discussed in paragraph 2.790(b) of NRC's regulations in 10 CFR
Part 2, "Rules of Practice for Domestic Licensing Pro ceedings and Issuance of Orders." It is essential that these procedures be followed so that the NRC can rec ognize that a request for withholding is being made and then consider the request on its merits.
Unless a formal request for withholding has been filed and properly supported with information required under 10 CFR 2.790, statements that manuals or doc uments are "confidential," "restricted," or "are to be the express property of Company X" should be re moved from all submittals, or a statement should be made that the notes are to be disregarded.
A QA program should contain, at a minimum, the following components to be approved by the NRC
staff. Each component contains a general description of the component, followed by additional, more pre scriptive information that applicants may find useful in developing a QA program. The additional information within each section is intended to provide specific methods for meeting each component.
The methods given here for each component are not the only methods for developing a QA program that would be acceptable to the NRC staf
f. The NRC
staff will consider a QA program that establishes and implements each of the 13 components listed in this section as meeting this guidance. The 13 components may be part of a QA program that is designed and in tended to meet another established standard or requirement, including programs established to meet International Organization of Standardization or the American National Standards Institute QA program standards, military standards, requirements or regula tions established by other U.S. Government agencies (such as the Food and Drug Administration). Howev er, the QA program should cover the manufacture and distribution of the products registered in accordance with 10 CFR 32.210.
1.
ORGANIZATION
The applicant's organizational structure, function al responsibilities, and levels of authority should be documented, starting with the Chief Executive Officer or equivalent, down to, at a minimum, the head of each department. Each person's responsibilities should be listed. All personnel in the QA department should be listed, along with their responsibilities. The applicant's NRC contact should be identified.
The QA Manager should report directly to the QA
Director. The QA Director should have continued in volvement in ensuring that the QA department is run ning properly. The QA Director and the QA Manager should have the authority, access to work areas, and organizational freedom to identify quality problems, recommend or initiate solutions, verify implementa tion of solutions, and halt production at any time to ensure that the device or production procedures con form to all regulations and specifications.
1.1 The organizational structure should be docu mented in the form of a flow chart, with a brief explanation of each position and the responsibili ties associated with the position. Position titles may be used in the flo* chart in lieu of the names of the persons occupying the positions.
1.2 In a small organization, the company president should be the QA Director, or the QA Director should report directly to the company president.
This may not be possible in larger organizations.
In larger organizations, the QA Director should be a person in upper management who does not have direct responsibility for production. This helps to ensure that quality is measured against the device specifications and not against other factors, such as production schedules.
1.3 The QA Manager should be responsible for the everyday workings of the QA program and should be responsible for reviewing and approv ing all changes to, or changes affecting, the QA
program.
1.4 Involvement by the QA Director should, at a minimum, consist of reviewing the audits of the
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QA program and periodically reviewing any updates, changes, problems, or concerns with the QA program. The QA Director should initi ate changes to the QA program as deemed necessary.
2. PERSONNEL
The applicant should have written procedures to ensure that persons have appropriate qualifications and training for the jobs they are performing. The applicant should keep records of each employee's edu cation, experience, training, indoctrinations on the technical obligations and requirements of his or her job, and either examination results or capability dem onstrations, including re-evaluations. The records should also provide verification that an employee is qualified to perform special procedures or testing (e.g., welding, heat treating, weld inspections).
The applicant should have written procedures for all training and indoctrinations.
2.1 Training of personnel may be formal, including a written outline of the training with a written or hands-on objective examination, or informal, including on-the-job training that includes a qualitative determination of the trainee's ability.
Both formal and informal training should be documented.
2.2 All employees should be subject to an initial eval uation of their skills and re-examination on an annual basis. The evaluation may be statistical analysis of inspection results of work performed by the employee or observation of the em ployee's work habits and skills, to ensure com pliance with the appropriate specifications. All evaluations and re-evaluations should be documented.
2.3 The applicant should have a list of employees qualified to perform each operation. This maybe achieved by maintaining a list of all persons qual ified to perform an operation, or each em ployee's training and qualification file may list the operations the employee is qualified to per form. The employee's supervisor should have ac cess to this information to verify the employee's qualifications.
2.4 Each employee's training and qualification file should include all necessary medical records that may affect the employee's job performance.
One example is that welders and inspectors may be required to have their vision tested annually.
2.5 The applicant should have a list of all employees qualified to perform special processes, testing, or inspections (e.g., welding, heat treating, weld in spection).
2.6 A sample of an employee training form is In cluded on page B-2 of Appendix B.
3. EQUIPMENT
All equipment used for measuring' testing, or in specting should be controlled, calibrated, and maintained. The applicant should have records of all repairs and calibrations of the equipment used for measuring, testing, or inspecting.
All calibrations should be traceable to the Nation al Institute of Standards and Technology (NIST) or a competent national authority. The calibration frequen cy should be dependent on the equipment's stability, purpose, and degree of usage and should be left to the discretion of the QA Manager. No calibration interval should exceed I calendar year.
All new equipment or equipment that has under gone maintenance that affects the accuracy of the equipment should be calibrated before use.
3.1 The applicant should have a historical log for each piece of equipment that is used in the pro duction of the device, enhances the quality of the device, or ensures that all specifications and regulations are met. The log should include the manufacturer of the equipment, the model num ber, serial number, and instructions for use. The log should contain records of routine or unsched uled maintenance of all equipment and contain maintenance procedures, nature of the mainte nance performed, date maintenance was per formed, date equipment is due for maintenance, and the frequency of the maintenance.
3.2 Records of calibrations should be kept in the log for each piece of equipment that includes the manufacturer, model number, serial number, calibration procedures, frequency of calibration, date calibrated, date due for calibration, and a list of persons qualified to calibrate the equip ment.
3.3 Equipment and calibration logs should be kept on a computer or hard card system. To ensure that uncalibrated equipment is not used, the sys tem should flag equipment that is nearing its due date for calibration.
3.4 AU calibration cycles should be 1 year or less.
The applicant may decide that the calibration cycle should exceed 1 year for specific equip ment that is expensive to calibrate and is not likely to be out of calibration..
3.5 Each piece of calibrated equipment should be traceable to its calibration record. Each piece of calibrated equipment should also be marked with its calibration date, date calibration is due, and the person or company who performed the cali bration. If it is impractical for the equipment itself to carry such a label, its case should be
6.9-4
labeled and the equipment should be traceable to its case.
3.6 If calibration Is performed by a supplier, a record of calibration from the supplier stating the date of calibration should be included in the calibra tion file.
Suppliers performing calibrations should demonstrate that all calibrations are traceable to NIST or a competent national au thority and should be audited like all other
.suppliers.
3.7 If any equipment has special procedures for han dling or storage, the equipment should be la beled or its case should be labeled with these pro cedures. If it is not possible to attach the procedure to the equipment or its case, the pro cedure should be on file and a label specifying where to find the procedures should be attached to the equipment or its case.
3.8 A sample page from an equipment log and sam ples of calibration labels are included on pages B-3 and B-4 of Appendix B.
4.
DESIGN AND DOCUMENT CONTROL
The applicant should have written procedures to ensure that all documents conform to the appropriate specifications and pertinent regulations. The proce dures should ensure that the documents include all special instructions for labeling, cleaning, handling, equipment settings, packaging, and storage, as well as special procedures, a list of all materials, all dimen sions with tolerances, and any special finishes that need to be applied. The procedures should ensure that the correct documents, reflecting all drawing changes and the correct revision level, are employed.
The procedures should ensure that each docu ment is released only after it has been reviewed and approved by someone other than the person who pre pared that document. The procedures should also en sure that any changes to the documents are controlled by measures commensurate with those applied to the original document and are conveyed to all appropriate departments. Minor changes, such as insignificant edi torial corrections, are not required to undergo the same review and approval process as the original docu ment. Any design or production changes that are dif ferent from those approved by a regulatory agency must be submitted to the appropriate regulatory agency, for approval, before implementation.
Records of all appropriate documents should be kept. The records should contain design and docu ment changes and the reasons for the changes.
4.1 The applicant should ensure that all appropriate documents used in the production of the device are up to date. One mechanism to accomplish this is to have a controlled list of recipients of the documents and have each recipient sign off that the most current document was received and is being used.
4.2 As soon as a document is revised, approved, and effective, the applicant should ensure that all previous copies of the document are pulled from production or ensure that the documents are not being used for production.
4.3 The applicant should ensure that the master co pies of the documents are controlled so that no previous revisions of the documents are issued or used.
4.4 The applicant should have a list that reflects all current documents and their appropriate revi sions. Documents currently being revised should be noted on the list.
4.5 To ensure that all documents are complete and accurate, each document should be reviewed and approved by someone of equal or greater proficiency. The reviewer should sign the docu ment to show approval. Other affected depart ments, such as QA and production, should review the document before releas
e. The NRC
contact should review and approve all document revisions if the document was submitted as part of the device registration or license application.
The NRC contact should halt issuance of the document if NRC approval is required.
4.6 A file should be kept for each document. The file should include all previous revisions of the document, all changes to the document, the rea sons for the changes to the document, and all persons who have received controlled copies of the document.
4.7 Procedures for reviewing the documents should include a checklist of the types of items that should be included in the documents. If any item on the checklist is missing, the reviewer should ensure that it was not inadvertently excluded from the document.
4.8 If the applicant is a redistributor, the applicant may not need to approve all document changes.
However, the applicant should receive copies of all document changes.
4.9 If the applicant is a distributor of devices com pletely manufactured by persons who are not NRC licensees, the applicant should adopt a pro gram that ensures that all document revisions are reviewed and approved if the document was sub mitted as part of the device registration or license application. The applicant should halt issuance of the document if NRC approval is required.
The program should ensure that the applicant re ceives copies of all document changes.
6.9-5
4.10 Samples of an engineering change request, an engineering change notice, and a drawing issue checklist are included on pages B-5, B-6, and B-7 of Appendix B.
5.
MATERIAL AND SERVICE
PROCUREMENT
All materials and procedures used to produce the device must meet specifications and pertinent regula tions. Procurement of materials or services must be controlled to ensure conformance with specifications.
Suppliers should demonstrate that they are capa ble of supplying material or services in accordance with the requirements and specifications.
Inspections should be performed on all items re ceived from suppliers upon receipt. The extent of re ceipt inspection should depend on the supplier and should be left to the discretion of the QA Manager.
Before issuance of an order for materials or serv ices, the applicant should provide to the supplier the scope of the work, technical requirements, identifica tion of the documents that should accompany the ma terial or service, identification of the documents that the supplier should keep on file, requirements for re porting and approving dispositions of nonconfor mances, and the signature of an authorized purchasing agent.
The applicant should have written procedures for, and records of, procurement of materials or services and inspection upon their receipt.
5.1 Selection of a supplier should be based on the supplier's past history of providing identical or similar materials or services and the supplier's technical capability, as determined by direct evaluation of the facility or by analysis of the quality of previously supplied materials or serv ices. If the quality of the product cannot be de termined through inspection or testing, the selec tion of a supplier should be based on the results of an audit of the supplier's operations.
5.2 For each supplier, the level of receipt inspection should be based on past performance and the results of audits of the supplier's operations. In spections on receipt may range from inspection of 100 percent of the materials or services received from new, nonaudited suppliers to inspection of a sample, based on an accepted sampling plan, of the materials or services received from audited suppliers with good past performance. The sample sizes should be in creased if the quality of the materials or services received decreases. The decrease may be seen from the trend analysis performed on the inspec tion records or from the audits of the supplier's operations.
5.3 The applicant should develop a qualified supplier list. The list should include all suppliers who have demonstrated that they are capable of supplying the materials or services to the applicant. The applicant should then procure materials or serv ices only from suppliers on the qualified supplier list. The qualified supplier list should be con trolled so that no unqualified suppliers are included on the list.
5.4 In lieu of forwarding all the relevant information to the supplier each time an order is placed, the applicant may initiate a written contract with a supplier. The contract should contain the rele vant information. If the applicant has a contract with the supplier, the applicant should ensure that the supplier has copies of, and is using, the most current documents pertaining to the order.
5.5 If the applicant is a redistributor or a distnrbutor of devices that are not completely manufactured by NRC licensees, the applicant must ensure that an operational check is performed on 100 per cent of the devices and inspect, to the extent pos sible, 100 percent of the devices to ensure that they meet their design specifications.
5.6 Samples of a purchase requisition and a purchase order are included on pages B-8 and B-9 of Appendix B.
6. INVENTORY
The applicant should have written inventory pro cedures that include procedures for special handling, marking, tagging, labeling, segregating, recordkeeping, and handling of nonconforming material. The invento ry procedures should account for material that has a shelf life and ensure that the proper materials are used in the production process.
The inventory procedures should include provi sions for in-process material and finished devices. The procedures should ensure that only items that have passed inspection are used in the production process, and that completed devices have passed their final in spections and testing before distribution.
6.1 All inventory that has a shelf life, such as adhe sives and gaskets, should be used on a first-in/
first-out basis, and the inventory system must be controlled so that items that have exceeded their shelf life are not used. This may be achieved by marking the containers with the expiration date of the material.
6.2 Handling and inventory procedures should en sure that materials or devices that are segregated or identified as complete have passed their final inspections and tests. This may be achieved by having the inspector mark or tag the product as having been inspected, or by having the invento ry area controlled and only having items that have passed inspection enter the controlled area.
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6.3 To ensure that the correct materials are used in production and that the items have passed their inspection, the applicant may have a staging area in which all materials needed for production are brought together by inventory personnel. The inventory personnel should verify that the cor rect materials are used and that they have passed their inspection.
6.4 Inventory items should be clearly marked or seg regated to prevent use of the wrong materials.
Materials that are so similar that they may be confused with other materials (e.g., different al loys of steel, similar size springs) should not be located next to each other.
7. PRODUCTION PROCEDURES AND
PROCESSES
The applicant should have written procedures for all production processes. The procedures should include all necessary instructions, including the ma chinery, equipment, and qualifications of the worker needed to perform the task. The procedures should also include inspection or testing hold points. Not all tasks need to be listed in the procedures. For example, procedures for cutting stock material to length may not need to be listed in the procedures.
7.1 Production procedures should be adequate for the operation to be performed. They may be as simple as a detailed engineering drawing of the part or device, with notes indicating any special instructions, cautions, or methods of construc tion. More detailed, step-by-step written proce dures may be necessary for some complicated operations.
7.2 Production procedures should include appropri ate hold points. These may be detailed as part of the production procedure or indicated as a note on the production drawing.
7.3 The applicant should specify the flow of materi als and processes in the form of a flow chart or a traveler that accompanies the item (see example on page B-11). Inspection hold points should be included in the flow chart or traveler.
7.4 As necessary, the procedures should specify the qualifications of the workers needed to perform each operation. This may be accomplished by classifying workers to certain skill levels, such as classes of machinists, welders, or inspectors. If the worker's qualifications are not identified in the production procedures, the production de partment should have a mechanism to ensure that the worker performing the task is qualified to perform the task and to operate the equip ment needed to perform the task.
7.5 If the applicant is a redistributor or a distributor of devices completely manufactured by other persons and is not performing repairs or rework to nonconforming devices, the applicant's pro duction procedures may only include inspection, testing, and distribution procedures. If the applicant performs repairs or rework, the appli cant should adopt appropriate maintenance procedures.
7.6 An example of an inspection traveler is on page B-II of Appendix B, and samples of a fabrica tion flow chart and a logic chart for preparing an inspection traveler are on pages B-15 and B-16 of Appendix B.
8.
INSPECTION AND TESTING
The applicant must ensure that all materials, de vices, and production procedures conform to the ap propriate specifications and regulations. The applicant should have written procedures for in-process inspec tion and testing of materials, production processes, and final inspection and testing of the device. The pro cedures should include acceptance criteria and proce dures for receipt inspection, generating sample sizes, final inspection and testing, packaging and transporta tion' inspections, and audits of production procedures.
The inspection should be performed by someone other than the person who performed the work being in spected.
The procedures should also include an inspection schedule that includes mandatory hold points beyond which work should not proceed without successful completion of the inspection or test. The procedures should include provisions for bypassing inspections or tests and provisions for nonconforming materials.
Records should be maintained of all inspections and tests results and should include the date and person performing the inspection or test.
The applicant should have a means of segregating items that have passed inspection or testing.
8.1 Procedures used to generate sample sizes should be based on industry standards.
8.2 Hold points may be specified on a traveler that follows the device through the production proc ess. The traveler would indicate the hold points and the types of inspections or tests to be per formed. The traveler may be designed to be a record indicating that the inspections or tests have been performed. The traveler should be ap proved by QC personnel indicating that the in spection hold points are acceptable.
8.3 In-process inspection of some materials may be performed by sampling. However, 100 percent of materials critical to safety should be inspected.
The inspection may be sufficient if the materials and construction are verified as part of the operational check of the device. Materials criti cal to safety include any item that, if not
6.9-7
manufactured in accordance with its specifica tions, could by itself (i.e., in the absence of a failure of another component of the device) lead to an exposure higher than expected during nor mal use, handling, or storage of the device.
8.4 As part of the final inspection of the devices, NRC licenses require an operational check and a test for removable contamination on 100 percent of the devices before distribution.
8.5 After the inspections, the acceptable items should be tagged, marked, stamped, or segre gated from unacceptable items. A number of methods may be used to achieve this. Segrega tion of items may be achieved by physically pass ing the items to the next worker, indicating successful completion of the inspection, or by having the items placed in a controlled stock room or holding area.
8.6 Inspection of production processes should follow a checklist that lists the acceptance criteria.
Some inspections may be performed by qualified production staff instead of the QC department.
However, the QC department should inspect the processes at least yearly. All inspections should be documented.
8.7 If a production process is found to be insuffi cient, the inspection results and their impact on previously manufactured products should be evaluated by the QA, engineering, manufactur ing, and other appropriate departments. Appro priate corrective actions should be taken.
8.8 Manufacturers and distributors of smoke detec tors and sources used in smoke detectors should adopt inspection and testing programs that meet the "QC Program Specifications for the Man ufacture and Distribution of Smoke Detectors"
in Appendix C. Manufacturers and distributors of other products distributed to persons exempt from licensing should adopt the same inspection and testing requirements.
8.9 If the applicant is a redistributor or a distributor of devices completely manufacturid by persons who are not NRC licensees, the applicant should subject each device to final inspection and an op erational check before distribution.
8.10 Samples of a daily incoming inspection report, an inspection traveler, and a verification of con formance form are included on pages 10, 11, and 12 of Appendix B.
9. NONCONFORMING MATERIALS
The applicant should have written procedures to ensure that materials and devices that do not conform to the specifications are not used in production or dis tributed. The procedures should have provisions for nonconforming materials found through receipt in spection, in-process and final inspection and testing, and devices returned by customers. The procedures should include identification of the nonconforming materials, disposition procedures, and provisions for returning reworked items back to production. Before nonconforming materials are returned to production or distributed, they should pass all appropriate inspec tions and tests. The applicant should keep records of all nonconformances and their disposition.
9.1 Nonconforming materials should either be segre gated in a controlled area or be marked as nonconforming.
9.2 Rework may be performed without prior approv al. However, repair to material should not be performed without appropriate approval.
9.3 Records of all nonconforming materials should be kept for trend analysis and for verification that the materials have not been used in the pro duction process.
9.4 A traveler form should be used to identify non conformances. The traveler should indicate the inspections and approvals needed. The QA and engineering departments should approve the dis position of nonconformances.
9.5 If the applicant is a redistributor or a distributor of devices completely manufactured by persons who are not NRC licensees, the applicant should have procedures indicating the disposition of nonconforming materials, including who is re sponsible for repair or rework.
9.6 Samples of a Nonconforming Materials Report and nonconforming material tags are included on pages B-13 and B-14 of Appendix B.
10. PACKAGING AND TRANSPORTATION
The applicant should have written procedures to ensure that all materials or devices shipped by the applicant are packaged and transported according to the regulations and specifications governing the mate rial. The procedures should include provisions for in spections of packaging and transportation. The pack aging and transportation should have no adverse effect on the material or device.
The procedures should also have provisions to en sure that appropriate paperwork or manuals (instruc tions, maintenance procedures, packing list, operation manuals, etc.) accompany the device.
Records should be kept of all packaging and ship ping reports and inspections.
10. 1 The applicant should have either a standard pro cedure for packaging all items leaving the facility or a unique packaging procedure for each Item as
6.9-8 K
K
it leaves the facility. The packaging procedure should include the form of transportation (e.g.,
name or type of transportation company, picked up by customer) and the labeling of the packaging.
10.2 Before distribution of any material or device, it should be verified that all items, including paper work, are included with the material or device or are being shipped separately. The customer should be notified if items are missing and that they will be sent at a later date. The system should ensure that back-ordered items are sent when they become available.
10.3 If the applicant is a redistributor or a distributor of devices completely manufactured by persons who are not NRC licensees, the device may be shipped from the manufacturer or initial distribu tor to the customer, and therefore packaging and transportation procedures may not be necessary.
If the device is shipped from the applicant's facil ity, the applicant should have procedures for packaging and transportation of devices.
11. DEVIATIONS AND CUSTOMER
COMPLAINTS
The applicant should have written procedures for evaluating and recording deviations, whether reported by customers or suppliers or found through inspections or customer complaints, either by telephone or in writ ten form. The procedures must adequately address the evaluation and notification requirements listed in 10
CFR 21.21. Records should be kept of each deviation or complaint that the applicant receives. The records should contain the device type and model number, se rial number (if applicable), name of complainant, na ture and date of the complaint, reply to complainant, corrective action taken, and root cause of the failure If known. The procedures should ensure that the QA
Manager and the department that was responsible for the failure are notified of the deviation or complaint and the corrective action. All known customers that may be affected by the failure or complaint should be instructed to take appropriate corrective action.
Trend analysis should be performed on all devi ations. The analysis should be on-going and be per formed at least yearly.
11.1 The applicant should have a log of complaints received from customers by phone or in writing.
The log should include: device type and model number, serial number, name of complainant, nature and date of the complaint, reply to com plainant, corrective action taken, and root cause of the failure, if known.
11.2 Trend analysis should be, at a minimum, by type of failure and model number of the device. Any trends arising should be investigated for possible generic problems.
11.3 The applicant should have written procedures for contacting affected customers and procedures for determining whether customers are affected by a failure or complaint. If it appears that the failure or complaint is a result of a generic design or manufacturing problem, all known users of a device that may have the same failure should be notified. The procedures should ensure that the NRC is notified of failures or generic design or manufacturing problems that may be related to their license or registration of the product.
11.4 The department responsible for the deviation should be notified as soon as practicable to pre vent additional deviations.
11.5 A sample customer complaint form is included on pages B-17 and B-18 of Appendix B.
1
2. AUDITS
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 encompasses all the requirements of the applicable regulations. Audit procedures should include accep tance criteria and assurance that all procedures are up to date.
The person performing audits should have no re sponsibility for the matters being audited.
Records of all audits should be kept on file and reviewed by the personnel responsible for the matters being audited. Audit records should indicate deficient areas in the program and corrective actions. Follow-up actions should be taken to verify that corrective actions are accomplished. All records should be signed and dated by the appropriate company officer.
Internal audits should be performed at intervals not to exceed 1 year. The frequency of audits of suppliers should be left to the discretion of the QA
Manager, but the interval between audits should not exceed 3 years.
12.1 The applicant should have standard written pro cedures for auditing its QA program and for au diting its suppliers. A written checklist specifying the necessary components of the QA program should be completed as a record of the audit.
12.2 The completed audit checklist should include the signature of the auditor, signature of the person responsible for the area being audited, and the date of the audit. If the audit reveals deficient areas of the program, the deficient areas should be noted on the checklist, and the deficient areas should be re-audited. The auditor should again sign the checklist when all deficiencies have been corrected.
If the deficiencies are minor, the
6.9-9
auditor may allow. them to be corrected before completion of the audit or may agree with the corrective action to be taken. In these cases a re-audit is not necessary.
12.3 If audits are used to verify employees' perform ance, the procedure for the audits should specify the acceptance criteria for the job being per formed. A record of the audit should be kept.
12.4 In small companies, it may not be possible for the auditor to have no responsibility for the matters being audited. If this is the case, the applicant should consider having some of the audits per formed by outside auditors.
12.5 If the applicant is a distributor of devices com pletely manufactured by persons who are not NRC licensees, it is extremely Important that the applicant perform frequent detailed audits of the manufacturer's operations.
13. RECORDS AND DOCUMENTATION
The QA Department should ensure that all appro priate pertinent records are maintained and filed. This includes the results of tests, inspections, and audits, as well as copies of up-to-date written procedures. The objective is to ensure that each component of the QA
program has been properly implemented. The records should be accessible to each appropriate regulatory agency and should be kept for the useful life of the device.
13.1 Records may vary in form and content and are dependent on the size of the operation and past performances. The record may consist of as little as a signed log or checklist indicating that the inspection or audit has been performed, or it may include the actual values identified during the inspection. More detailed records may be necessary if past performance has been below acceptable levels. Analysis of the records may In dicate procedural or design weaknesses.
13.2 Records of audits and inspections and all neces sary documentation should be available to the necessary departments.
13.3 The QA Department should have access to the master copies of all records and documentation.
13.4 Samples of records and documentation for QA
programs are included in Appendix B. Appendix B is not an all-inclusive listing of records and documents. The records and documents are for guidance only, and applicants are not required to have identical documents and records. Appli cants should have documents and records tai lored to their own programs.
D. IMPLEMENTATION
The purpose of this section is to provide informa tion to applicants or licensees regarding the NRC
staff's plans for using this regulatory guide.
Except In those cases in which an applicant or li censee proposes an acceptable alternative method for complying with specified portions of the Commission's regulations, the method described in this guide reflect ing public comments will be used In the evaluation of
(1) submittals by applicants to establish QA programs for manufacture, distribution, or redistribution of the sealed sources or devices and (2) registrants' and li censees' performance with respect to developing, es tablishing, and maintaining such QA programs.
6.9-10
K.
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
RATING*
QUESTIONS
I
PROGRAM/IMPLEMENTATION
COMMENTS
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?
9.
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 audit.
A-2 S
S
r
RATING*
(QUESTIONS
ROGRAMI
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
RATING*
QUESTIONS
____
_
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;
4-does not exist; S-not applicable; 6-did not audit.
A-6 K
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?
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 K
QUESTONS
I
RATING*
PROGRAMAnLEMETON
COMMENTS
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 I,
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:
MANUFACTURER:
USED FOR:
_________SERIAL
NUMBER:____________
INSTRUCTIONS FOR USE,
MAINTENANCE,
CALIBRATION:
MAINTENANCE FREQUENCY:
CALIBRATION FREQUENCY:
PERFORMED
DATE
CALI.
MAIN.
BY
COMMENTS
B-3
CALIBRATION LABELS:
OUT OF CALIBRATION
j DO NOT USE
I
CALIBRATION NOT
REQUIRED
B-4 CALIBRATION
MODEL #:_SERIAL
DATE CALIBRATED:
DATE DUE FOR CALIBRATION:
CALIBRATED BY:
r"
="
EMfIRIM(
tI-lANE
REQUEST
ECR#
I
wrn'IPY SUPPLIER
YES
NO
B-5 l.ll..It,
5Itl u
vn Sn.
--.
-
...
..
MODEL/PART NO-
CUSTOMER/ORDER NO.
INITIATOR
DEPT.
DATE
REASON FOR CHANGE
TYPE OF 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
NOTIFY CUSTOMER
YES
NO
NOTIFY NRC
YES
NO
.
F
,
I
ENGINEERING CHANGE NOTICE
MODEL/PART NO.
CUSTOMER/ORDER NO.
CHANGED BY
DOCUMENT NO.
REV.
CHECKED BY
DATE
RELEASED
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 FCN#
ECN#
DRAWING ISSUE CHECKLIST
TDATE
ORDER NUMBER
A_
The following drawings and/or documents have been sent to you since L I
.
Please review your recent receipts of documents and check the column as to whether you have received them or not.
Sign and date this form where indicated.
Return the marked original to me immediately and keep a copy for your records.
DRAWING
DOCUMENT
NUMB]
-ISSUE NUMBER
.1 -
4
1
1 l
E'
i certify that the previous revisions of the documents and I certify that the previous revisions of the documents and drawings have been recalled or accounted for:
Signature Date FIELD CHECKED BY I
DATE:
B-7 I
I
TO
FROM
RECID
NUMBER
DRAWING OR DOCUMENT NUMB]
REQUIsITIONED BY:
DEPARTMENT:
PURCHASE REQUISITION
PURCHASE CHANGE
P.O. NUMBER
CHANGE NO.
ORDER DATE
DELIVERY DATE
F.O.B.
DATE
DATE DELIVERY
REQUIRED
VIA
ITEM
QUANTITY &
PART
SUPPLIER NUMBER &
NO.
UNITS
NUMBER
DESCRIPTION
t t
I.
I.
I.
i i
- 1 I
-I
t I
t t
S--It___
I
SUPPLIER:
B-8 PURCHASE REQUISITION
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
B-11
, I
! I
INSPECTION AND TEST
POINTS TO'PERFORM
TO BE PERFORMED
INSPECTION/TEST
- INSP./TEST
PERFORMED
PASS/
DATE
PERFORMED
BY
FAIL
COMMENTS
VERIFICATION OF CONFORMANCE
Date:
Company:
Address:
Purchase Order:
Item/Part Number:
Contract:
This certificate assures that the items listed below conditions of Purchase Order (P.O.#)
, Contract (contract #)
, and their engineering drawings.
conform to all the ITEM NUMBER
PART NUMBER
DRAWING NUMBER
DESCRIPTION
COMPANY NAME
SIGNATURE
DATE
TITLE
SIGNATURE
DATE
(Witness)
B-12 BY:
NONCONFORMING MATERIAL REPORT
NCMR#
SUPPLIER
PURCHASE ORDER NO.
INSPECTOR
DATE RECEIVED
BUYER
DATE INSPECTED
DESCRIPTION
LOCATION
T1P1w!
DESCRIPTION OF NONCONFORMANCE
Tf I
DECRPIO---ONONOMAC
I.
I.
i.
_____________I
QUALITY
AS IS
COMMENTS/REWOR
INSTRUCTIONS:
REPAIR/REWORK
RETURN TO SUPPLIER
SHORTAGE
REWORKED AND RE-INSPECTED:
SIGNATURE
DATE
B-13 I I
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 &
inn-process Yefna Inscen&io n
requre test rquire Sdue to historyN
standa-dzatlon, &M"
- >
No Estalsh fuinable yDecision Those in-proces & final Inspections & tests presently L llii i ii specified In mnanufacturers fC
or QaA manual Proide supplcessntayDsgnoe 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 '
o yFoilsinFoils
5'n FButton Completed FogsOnl ButonIon Chazmber
1) 100% Tested for Removable Contamination
2) Use Lot Tolerance Percent Defective (LTPD)*5% Acceptance Sampling for Conformity to Design Specifications YES
NO
SMOKE DETECTOR MANUFACTURER
I
I
Ndor to Final Packaging.
Pft xto final Pf"
1) 100% Test flor Removable Contaiato
1) LTPO5%sampling to Rmval an Button or Ion Ch'amber Contmiaton anButton 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 number of defectives (or defects) in the sample or samples under consideration that will permit the acceptance of the inspection lot.
2.
Acceptance Sampling means inspection sampling in which decisions are made to accept or reject product; also, the procedures by which decisions to accept or reject are based on the results of the inspection of samples.
3.
Defect means an instance of a failure to meet a requirement imposed on a unit with respect to a single quality characteristic.
4.
A Defective means a defective unit; a unit of product that contains one or more defects with respect to the quality dcaracteristic(s)
under consideration.
5.
Design Conformance means a complete unit that has been inspected and has been shown to meet the design specifications that were submitted to and approved by NRC. Design specifications include detailed information about labeling, point of sale packaging, and detector construction.
6.
Disposition of Lot: If any units within a sample are observed to be defective, the entire lot must either be rejected or inspected. All failed units must pass the test criterion before release.
7.
Final Packaging is the packaging in which the unit is contained for sale to the end user.
Also known as market package.
8.
Inspection means the process of measuring, examining, testing, gauging, or otherwise comparing the unit with the applicable requirements.
9.
Lot Tolerance Percent Defective (LTPD) is defined by the American Society for Quality Control as "... expressed in percentage defective, the poorest quality in an individual lot that should be accepted."
10.
Quality Characteristics are the test criteria.
The devices must have less than 185 becquerels (0.005 microcurie) of removable contamination and conform to the manufacturer's design specifications (e.g.,
labeling, packaging, construction, etc.). Up to 75 units may be tested for removable contamination, using one swipe. The trigger level for multiple units using one swipe is
185 becquerels (0.005 microcurie).
11.
Sample (n) means, in acceptance sampling, one or more units of product (where n is the number of units) drawn from a lot, for purposes of inspection, to reach a decision regarding acceptance of the lot.
12.
Sampling at Random, as commonly used in acceptance sampling theory, means the 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.
I
Federal Recycling Program
I
J
UNITED STATES
NUCLEAR REGULATORY COMMISSION
WASHINGTON, D.C. 20555-0001
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