1、 ASQC C1 96 m 0757506 0001739 388 m ANSVASQC Cl -1996 AMERICAN NATIONAL STANDARD Specification of General Requirements for a Quality Program AMERICAN SOCIETY FOR QUALITY CONTROL 61 1 EAST WISCONSIN AVENUE MILWAUKEE, WISCONSIN 53202 ASdC CL 96 = 0759506 OOOL740 OTT ANSVASQC Cl-1996 AMERICAN NATIONAL
2、STANDARD Specification of General Requirements - for a Quality Program Reaffirmation of ANSVASQC C1-1985 Prepared by American Society for Quality Control Standards Commitfee for American National Standards Committee Z- 1 on Quality Assurance An American National Standard Approved on February 26,1996
3、 Abstract: Specification of General Requirements for a Quality Program concerns the establishment and maintenance of a quality program by a contractor to assure compliance with contract requirements in the areas of quality management, design information, procurement, manufacture, acceptance, and doc
4、umentation. American National Standards: An American National Standard implies a consensus of those substantially concerned with its scope and provisions. An American National Standard is intended as a guide to aid the manufacturer, the consumer, and the general public. The existence of an American
5、National Standard does not in any respect preclude anyone, whether he or she has approved the standard or not, from manufacturing, purchasing, or using products, processes, or procedures not conforming to the standard. American National Standards are subject to periodic review and users are cautione
6、d to obtain the latest edition. Caution Notice: This American National Standard may be revised or withdrawn at any time. The procedures of the American National Standards Institute require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of p
7、ublication. Purchasers of American National Standards may receive current information on all standards by calling or writing the American National Standards Institute. ASQC CL 76 0757506 OOOL74L T36 01996 by ASQC AU rights reserved. No part of this book may be reprodud in any form or by any means, e
8、lectronic, mechanical, photo- copying, recording, or otherwise, without the prior written permission of the publisher. ASQC Mission: To facilitate continuous improvement and increase customer satisfaction by identifying, communicating, and promoting the use of quality principles, concepts, and techn
9、ologies; and thereby be recognized throughout the world as the leading authority on, and champion for, quality. 10987654321 Printed in the United States of America Printed on acid-free paper Published by: ASQC 611 East Wisconsin Avenue Milwaukee, Wisconsin 53202 ASQC Cl 96 0759506 OOOL7L)2 972 W ANS
10、UASQC Cl-1996 Foreword (This foreword is not part of American National Standard ANSUASQC Cl-1996, General Requirements for a Quality Program.) The Standards Committee of the American Society for Quality Control was formed in 1947, being “authorized to study and select symbols, concepts, terms, proce
11、dures, and other matters which it feels the Society might standardize to advan- tage and to make recommendations to the Board of Directors regarding such standardization.” The Standards Committee requires periodic review and reaffirmation or revision of ASQC standards at regular intervals. This stan
12、dard is a rehation of ANSUASQC Cl-1985, which was a revision of the 1968 version. The following individuals were members of the Writing Committee for ANWASQC Cl-1985: David L. Field, chairman William Anderson Andrew B. Andreason Arthur R. Blank Dr. c. L. carter Robert C. Cloutier J. Dol Thomas F. Fr
13、ongillo Charles W. Gaw Alfred Gieser H. D. Greiner Robert E. Jouppi Richard J. Laford Roger G. Langevin Barry Lawrimore Charles V. Leach Richard A. Maass John A. Malatesta Don McNeil Charles E. Meadows Meril Monashkin Robert A. Moms August B. Munde1 Paul E. Ruhling Ben Silver Walter Uhorchak Richard
14、 Weber Quitman White Jr. James C. Wilson Howard D. Wilson Marvin Weir ASQC CL 96 0759506 0003743 809 ANSVASQC Cl-1996 Contents Page 1 . finitiono of Te rms 1 1.2 QualitySystem . 1 1.3 Inspection . 1 1.4 MectedOrganization . 1 1.5 SpecifyingOrganization . 1 1.1 Qualityprogram . 1 1.6 Other ANSVASQC D
15、efinitions . 1 2 . scope . 1 2.2 GeneralPurpose . 1 2.3 Other ANSI/ISO/ASQC Quality System Stan the entire process of manufacture; and the packaging, storing, and shipping of material. The program shall provide that, as early as possible, dis- crepancies (product nonconformities and program defi- ci
16、encies) shall be discovered, reported, and corrective action taken. 2.3 Other ANSI/ISO/ASQC Quality System Standards Attention is called to the existence of other system stan- dards, including Q9OOO-1-1994 through 49004-1-1994, quality management and quality assurance standards. These are equivalent
17、 to the International Standards Orga- nization (ISO) 9000 series standards. ASQC CL 7b m 075750b 0003745 b8L m ANSVASQC Cl-1996 3. REQUIREMENTS 3.1 Quality Management 3.1.1 General. There shall be planning, direction, and control in the sense of measurement and evaluation of the effectiveness of the
18、 quality system and the quality program. 3.1.2 Organization. Administration of the quality pro- gram shall be vested in a responsible, authoritative element of the organization, with unhindered access to senior management. This organization shall be staffed by techni- cally competent personnel with
19、freedom to make decisions without pressure or bias. It shall also have authority to ensure that quality requirements are consistently applied and maintained. 33.2 Source Inspection. The buyer and his authorized representatives reserve the right to inspect, at the source, any supplies furnished or se
20、rvices rendered under the contract. Inspection at the source shall not necessarily constitute acceptance, nor shall it relieve the seller of his responsibility to furnish acceptable product. When it is not practical, cost effective, or feasible to determine quality conformance of purchased items upo
21、n receipt, inspection at the source may be performed 33.3 Purchased Material. All purchased material shall be evaluated to assure conformance with the requirements of applicable standards and specification. When required, shipment of materials shall be accompanied by verifiable objective evidence th
22、at demonstrates the conformance of material and processes to the requirements stated in the 3.1.3 Procedures. Written quality control, test, and inspection procedures shall be used for all pertinent operations and for material, process, and product evalua- tions. These procedures shall be kept curre
23、nt and shall be available at all locations where they will be used. purchase order or product specification. The validity of objective evidence of quality shall be verified periodically by the buyer. Provisions will be made for withholding from use all incoming supplies pending completion of each re
24、quired inspection and test or receipt of necessary test reports. The seller shall be notified whenever noncon- 3.2 Design Information 33.1 General. Design information for a product (such as drawings, specifications, and standards) shall be main- tained to ensure that the products are manufactured, i
25、nspected, and tested to the latest applicable requirements. In like manner, task definitions for a service shall be maintained to ensure that the services are performed and inspected to the latest applicable requirements. 3.2.2 Change Control. The Affected Organization will have a change control pro
26、gram acceptable to the Specify- ing Organization. All changes to design information or task definition shall be processed in a manner that will ensure accomplishment as specified, and a record of actual incorporation points (by date, batch, lot, unit, or other specific identification) shall be maint
27、ained 33 Procurement 33.1 General. Control over procurement sources shall be maintained to ensure that services and supplies conform to specified requirements, including this Standard. Purchase orders (or contracts) shall be controlled to ensure timely incorporation of pertinent technical and qualit
28、y require- ments, including authorized changes. Adequate records of inspections and tests performed on purchased material shall be maintained. forming materials are received and corrective action shall be initiated when warranted. 3.3.4 Raw Materials. Raw material shall normally be tested to determi
29、ne conformance to applicable specifica- tions. Unless otherwise specified by the purchase order or the product specification, certified test reports identifiable with the material may be accepted as evidence of such tests. When certifications are used as a basis for accep- tance, the test results sh
30、all be compared with specification requirements. Furthermore, the validity of certifications shall be periodically verified by the buyer through inde- pendent testing. 3.4 Material Control 3.4.1 General. Methods and facilities shall be established for contmlling the identification, handling, and sto
31、rage of pur- chased and fabricated material. The identitcation shall in- clude indications of the inspection status of the material. These controls shall be maintained hm the time of receipt of the material, through all processing or assembly until de- livery to the customer in order to protect the
32、material hm damage, deterioration, loss, or unauthorized substitution, etc. 3.5 Production 3.5.1 General. Control shall be maintained over produc- tion processes to prevent product or service nonconformity 2 ASQC Cl 96 m 0759506 0003746 518 m ANSVASQC C1-1996 and excessive variability, and to assure
33、 conformance of the characteristics of product and processes which can be ver- ified at the time and point of manufacture. 3.5.2 Process Control. Evaluations and controls shall be implemented and maintained at appropriately located points in the production process to assure continuous con- trol of p
34、roduct and service quality. 3.5.3 Special Processes. Methods and facilities shall be provided to assure conformance with requirements for special process specification, such as welding, plat- ing, anodizing, nondestructive testing, heat-treating, soldering, sterilizing, polymerizing, homogenizing, d
35、rying, carding, and testing of materials. Certifica- tions for personnel, processes, and equipment shall be maintained. 3.6 Acceptance 3.6.1 General. Inspection and testing of completed prod- ucts and services shall be performed as necessary to assure that contract requirements have been met. Survei
36、llance shall be maintained over handling, preservation, storage, marking, packing, and shipping operations to assure com- pliance with requirements and to prevent damage, deterio- ration, loss, or substitutions. 3.6.2 Sampling Inspection. Any acceptance sampling procedures that differ from those req
37、uired by the contract or specification shall afford adequate assurance that the quality meets acceptable levels. Such pdures are sub- ject to approval by the Specifying Organization. 3.6.3 Nonconforming Material. Procedures and facilities for the handling of nonconforming material shall require prom
38、inent identification of the material and prompt removal (if practical) from the work area. Unless other- wise provided in the product specification or contract, the Affected Organization has the option of scrapping the material or requesting disposition instructions from the Specifying Organization.
39、 3.7 Measuring Instruments 3.7.1 General. Validity of measurements and tests shall be assured through the use of suitable inspection measur- ing and test equipment of the range, accuracy, and preci- sion necessary to determine conformance of articles. Calibration procedures shall be utilized and mea
40、sure- ments shall be performed by qualified personnel in an environment controlled to the extent necessary to as- sure the required accuracy. At intervals established to ensure continued validity, measuring devices shall be verified or calibrated against certified standards that are traceable to nat
41、ional standards or naturally occur- ring physical constants. Tooling used as media of inspection shall be included in this program. Further- more, every device so verified shall bear an indication attesting to the current status and showing the date (or other basis) on which inspection or recalibrat
42、ion is required next. 3.8 Interpretation of Limits 3.8.1 General. All limits are considered to be absolute. Limits, regardless of the number of places, are to be con- sidered as being continued with zeros. For purposes of determining conformance with limits, the measured value is compared directly w
43、ith the specified value with- out rounding. Any deviation, however small, outside the specified limit- ing value simes nonconformance with that limit. 3.9 Quality Information 3.9.1 General. Information from control areas described in paragraphs 3.1 through 3.7 of this American National Standard shal
44、l be systematically utilized for the preven- tion, detection, and correction of deficiencies in the pro- gram that affect quality. 3.9.2 Quality Records. Inspection and test records shall be maintained for both conforming and nonconforming product. Unless otherwise required by the Specifying Organiz
45、ation (or by law), the Affected Organization shall retain all quality records for a period of three years after the final delivery under an order or contract. Such records shall be available to the Specifying Organization upon request. A continuing review of these records and internal audit- ing rec
46、ords shall be made, and summary information shall be reported periodically to responsible manage- ment. All records shall be mechanically generated or handwritten in ink, dated, and traceable to the originator of the data. 3 ANWASQC C1-1996 3.93 Corrective Action. Prompt action shall be taken to cor
47、rect conditions that cause nonconforming materials and program problems. Use shall be made of feedback data generated by the customer as well as data generated internally. 4. QUALITY PROGRAM AUDITS 4.1 Internal Audits Internal quality audits shall be conducted by the AfFected Organization to assure
48、the adequacy of the program and the quality of product. 4.2 ExtemalAudits Quality programs will be audited by the Specifying Orga- nization for conformance to the intent of this American National Standard. Disapproval of the program or major portions thereof may be cause for withholding accep- tance of product or disqualification from future business considerations. 4 ASQC CL 9b -0759506 OOOL7L)d 390 = ASQC 611 EAST WISCONSIN AVENUE P.O. BOX 3005 MILWAUKEE, WISCONSIN 53201-3005 (414) 272-8575 FAX (414) 272-1734 800-248-1946 T60 Printed in the United States of America
