质量记录管理程序

1、department/section:quality assuranceeffective date:03/15/00cp number:4104-r5title:quality records managementissued by:j. googepage: 3 of 3standard operating proceduresupersedes:06/05/97qs1.0purpose1.1to establish a formal procedure that makes provisions for the identification, collection, filing, st

2、orage, maintenance and disposition of quality records.1.2to demonstrate with documented evidence the effective operation of the quality system.1.3to insure the production of parts and products meet specifications and contractual requirements; and to demonstrate the achievement of a satisfactory leve

3、l of quality.2.0 applicability2.1the provisions of this procedure apply to all documents, reports, test records and customer service documents that relate to product quality. included are vendor certificates, all receiving and internal test records, special testing, studies and records.2.2types of v

4、endor records.2.2.1certification test reports.2.2.2contracts with subcontractors.2.3types of internal test records.2.3.1internal audit reports.2.3.2process control data and studies.2.3.3raw material, receiving, in-process and finished product test data.2.4special testing and records.2.4.1calibration

5、 data for test and measuring equipment.2.4.2manufacturing related documents.2.4.3product traceability data.2.5external customer information.2.5.1warranty information.2.5.2customer surveys.2.5.3customer complaints.3.0responsibilities3.1many quality related documents and manufacturing procedures estab

6、lish requirements for certain testing. the department or staff support function that initiates the requirement or performs the test is responsible for designating the form to be used, reporting, storage and retention requirements.4.0identification and maintenance 4.1quality related documents and rec

7、ords will meet the following minimum requirements.4.1.1be dated, legible and identify the part, product or activity involved.4.1.2be filed, stored and maintained in a manner that permits easy retrieval.4.1.3maintained in a container and environment that prevents deterioration or damage.5.0retention,

8、 review and disposition5.1records will be reviewed periodically for applicability, age, and retention.5.2records that are two years old may be moved to an inactive file location.5.3quality related documents will be maintained for a period of time as specified in “appendix a”.5.4expired documents wil

9、l be reviewed for possible destruction. records containing special information that may have future value may be retained beyond the retention period. documents containing non-sensitive data will be discarded. documents containing sensitive data will be shredded.6.0customer relations6.1the sharing o

10、f quality related data with customers or external certifying agencies will be done only in those instances where an outside regulatory body directs, a previous contractual agreement exists, or when specifically approved by the director of quality assurance.issue date:march 15, 2000revised from:june

11、5, 1997reason for revision:revised procedure to include cgp and bradley direct on the distribution list.distribution:quality assurancemanufacturing technical supportplant administrationsales support productionwarranty/call center purchasing product engineering bradley direct qacgp process control re

12、ference pointbradley direct appendix aleveltype report or recordretention periodi.daily process checks and audit forms6 monthssnap/parts bag auditsend of line inspection reportsorder/contract review recordsii.calibration reports/results3 yearsfield reports/complaintsfinal product assembly testingfir

13、st piece reportsfirst article reportsreceiving inspection, measuring and testingin process test reportsvendor certificates of compliancevendor qualification/certificationcorrective action reportspurchasing recordswarranty reports/recordsreports of non-conforming parts & products (ncqr)concession reportsreports physical test/measurementgas burn certificates for third part agenciesinternal audit reportsprocess qualification reportsmanufacturing deviation authorizationsfactory test reportsiii.product safety/reliability test reports5 y