SECTION/ISO9001 REFERENCETOPICQSR REFERENCE
1.0/ N/ASCOPEN/A
2.0/ N/AAPPLICATIONN/A
3.0/ N/APROCEDUREN/A
4.1MANAGEMENT RESPONSIBILITY820.20
4.1.1QUALITY POLICY820.20(a)
4.1.2ORGANIZATION820.20(b)
4.1.2.1RESPONSIBILITY AND AUTHORITY820.20(b)(1)
4.1.2.2RESOURCES820.20(b)(2)/820.25
4.1.2.3MANAGEMENT REPRESENTATIVE820.20(b)(3)
4.1.3MANAGEMENT REVIEW820.20(c)
4.2QUALITY SYSTEM820.5
4.2.1GENERALN/A
4.2.2QUALITY SYSTEM PROCEDURES820.20(e)
4.2.3QUALITY PLANNING820.20(d)
4.3CONTRACT REVIEWN/A
4.3.1GENERALN/A
4.3.2REVIEWN/A
4.3.3AMENDMENT TO CONTRACTN/A
4.3.4RECORDSN/A
4.4DESIGN CONTROL820.30
4.4.1GENERAL820.30(a)
4.4.2DESIGN & DEVELOPMENT PLANNING820.30(b)
4.4.3ORGANIZATIONAL & TECHNICALN/A
INTERFACES
4.4.4DESIGN INPUT820.30(c)
4.4.5DESIGN OUTPUT820.30(d)
4.4.6DESIGN REVIEW820.30(e)
4.4.7DESIGN VERIFICATION820.30(f)
4.4.8DESIGN VALIDATION820.30(g)
4.4.9DESIGN CHANGES820.30(i)
INDEX (CONTINUED)
SECTION/ISO9001 REFERENCETOPICQSR REFERENCE
4.5DOCUMENT AND DATA CONTROL820.40
4.5.2DOCUMENT AND DATA APPROVAL820.40(a)
ISSUE
4.5.3DOCUMENT AND DATA820.40(b)
CHANGES/NOTIFICATIONS PURCHASING
4.6PURCHASING820.50
4.6.2EVALUATION OF SUB-CONTRACTORS820.50(a)
4.6.3PURCHASING DATA820.50(b)
4.6.4VERIFICATION OF PURCHASEDN/A
PRODUCT
4.7CONTROL OF CUSTOMER SUPPLIEDN/A
4.8PRODUCT IDENTIFICATION AND820.60/820.65
TRACEABILITY
4.9PROCESS CONTROL820.70(a) THRU (i)
4.10INSPECTION AND TESTING820.80
4.10.1GENERAL820.80(a)
4.10.2RECEIVING INSPECTION AND820.80(b)
TESTING
4.10.3IN-PROCESS INSPECTION AND820.80(c)
TESTING
4.10.4FINAL INSPECTION AND TESTING820.80(d)
4.10.5INSPECTION AND TEST RECORDS820.80(e)
4.11CONTROL OF INSPECTION,820.72
MEASURING, & TEST EQUIPMENT
4.11.1GENERAL820.72(a)
4.11.2CONTROL PROCEDURE820.72(b)
4.12INSPECTION AND TEST STATUS820.86
4.13CONTROL OF NON-CONFORMING820.90
PRODUCT
4.13.1GENERAL820.90
INDEX (CONTINUED)
SECTION/ISO9001 REFERENCETOPICQSR REFERENCE
4.13.2REVIEW AND DISPOSITION OF820.90(a)(b)
NON-CONFORMING PRODUCT
4.14CORRECTIVE AND PREVENTATIVE820.100(a)(b)
ACTION
4.15HANDLING, STORAGE, PACKAGINGN/A
AND DELIVERY
4.15.1GENERALN/A
4.15.2HANDLING820.140
4.15.3STORAGE820.150(b)
4.15.4PACKAGING AND LABELING820.120(a) THRU(e)/
20.130/820.170(a)(b)
4.15.5PRESERVATION820.120(a)
4.15.6DELIVERY820.160
4.16CONTROL OF QUALITY RECORDS820.180(a)(b)(c)/
820.181(a) THRU (e)/
820.184/820.186/
820.198
4.17INTERNAL QUALITY AUDITS820.22
4.18TRAINING820.25(b)
4.19SERVICING820.200
4.20STATISTICAL TECHNIQUES820.250(a)(b)
SECTION 1.0 SCOPE
THIS MANUAL IS THE GUIDING DOCUMENT FOR THE MANAGEMENT OF QUALITY AT LABORATORIES, CITY, USA. THE QUALITY MANUAL HEREIN COMPLIES WITH EN ISO 9001: 1994 AND SUPPORTS CONFORMANCE TO:
- EN46001
- D15 13485.2
- MDD/93/42/EEC
- REGULATIONS ESTABLISHING QUALITY SYSTEM REGULATIONS FOR MEDICAL DEVICES 21 CFR PART 820 (US FOOD AND DRUG ADMINISTRATION)
- SAFE MEDICAL DEVICES ACT: 1990
- CORPORATE GUIDELINES AND PROCEDURES
SECTION 2.0 APPLICATION
THIS MANUAL PERTAINS TO THE DESIGN, MANUFACTURE, AND DISTRIBUTION OF AND RELATED ACCESSORIES MANUFACTURED AT THE FOLLOWING FACILITY:
THIS MANUAL IS SUBJECT TO THE REVISION CONTROL, RETENTION, AND DISTRIBUTION PROCEDURES FOLLOWED FOR QUALITY DOCUMENTATION AT .
SECTION 3.0 PROCEDURE
NOTE: THE FOLLOWING SECTIONS ARE ALIGNED WITH CORRESPONDING EN ISO 9001: 1994 STANDARD SECTIONS.
SECTION 4.1 MANAGEMENT RESPONSIBILITY
4.1.1 QUALITY POLICY
"IT IS THE POLICY OF TO PERPETUATE A QUALITY ENVIRONMENT THAT FACILITATES CONTINUOUS IMPROVEMENT THROUGH EMPLOYEE INVOLVEMENT RESULTING IN THE HIGHEST VALUE OF PRODUCTS AND SERVICES THAT PUT THE CUSTOMER FIRST. QUALITY IS THE KEY TO OUR FUTURE."
THE QUALITY POLICY DESCRIBED ABOVE AND WHICH IS CONTAINED IN THIS DOCUMENT IS THE CONTROLLED POLICY AUTHORIZED BY SENIOR SITE MANAGEMENT. OTHER INSTANCES OF THIS POLICY ARE FOR INFORMATION PURPOSES ONLY AND ARE NOT CONTROLLED COPIES.
THE MISSION STATEMENT OF IS:
4.1.2ORGANIZATION
4.1.2.1RESPONSIBILITY AND AUTHORITY
GENERAL
ALL EMPLOYEES OF ARE RESPONSIBLE FOR ADHERING TO THE QUALITY SYSTEMS DESCRIBED HEREIN. MEMBERS OF MANAGEMENT HAVE AUTHORITY AND RESPONSIBILITY FOR THE DESIGN AND IMPLEMENTATION OF THE QUALITY SYSTEMS AND MAY DELEGATE THIS AUTHORITY AS APPROPRIATE. SPECIFIC RESPONSIBILITIES ARE DESCRIBED BELOW:
PLANT MANAGER
RESPONSIBLE FOR ASSURING THAT THE QUALITY POLICY IS IMPLEMENTED AND UNDERSTOOD BY ALL EMPLOYEES. THE PLANT MANAGER DEFINES THE RESPONSIBILITY AND AUTHORITY OF THOSE DEPARTMENTS AND INDIVIDUALS HAVING RESPONSIBILITY FOR QUALITY AND ASSURES COMPLIANCE WITH THE SYSTEMS OUTLINED IN THE QUALITY MANUAL (SEE ATTACHMENT I).
PLANT QUALITY ASSURANCE MANAGER RESPONSIBLE FOR: (SEE ATTACHMENT II)
-ENFORCEMENT OF THE QUALITY POLICY AND QUALITY SYSTEMS OUTLINED IN THIS MANUAL
-MAINTAINING INSPECTION AND TEST RECORDS
-ASSURING INSPECTION AND TEST STATUS
-ASSURING CORRECTIVE ACTION IS IMPLEMENTED AND VERIFIED FOR IDENTIFIED PROBLEMS
-ASSESSMENT OF THE QUALITY SYSTEMS
-PROVIDING STATISTICAL AIDS WHERE APPROPRIATE
-PLACING PRODUCT ON A Q.A. HOLD UNTIL FINAL DISPOSITION, AND/OR NON-CONFORMANCE IS RECONCILED AND NOTIFYING DIVISION OF POSSIBLE PRODUCT ACTIONS, WHEN NECESSARY
-ESTABLISHING AND ENFORCING A SYSTEM FOR THE CONTROL OF NON-CONFORMING PRODUCT
-ASSURING THE TIMELY INVESTIGATION AND ANALYSIS OF CUSTOMER COMPLAINTS
-ACCEPTANCE AND REJECTION OF RAW MATERIALS, IN-PROCESS, AND FINISHED PRODUCT
-IDENTIFICATION AND SEGREGATION OF ACCEPTED AND REJECTED PRODUCT
-INITIATION OF PROCESS TO RECALL PRODUCT
-MAINTAINING THE VALIDATION AND CERTIFICATION SYSTEMS FOR REGULATORY COMPLIANCE
-APPROVING VALIDATION PROTOCOLS, TEST PROCEDURES, AND VALIDATION RESULTS
-ESTABLISHMENT OF SYSTEMS TO ENSURE PRODUCT MEETS THE SPECIFIED REQUIREMENTS OF EN/ISO STANDARDS, WHERE APPLICABLE
-ENSURING THAT REGULAR INTERNAL QUALITY AUDITS ARE PERFORMED
-MAINTAIN CALIBRATION COMPLIANCE FOR TEST AND RELEASE INSTRUMENTATION AS WELL AS PRODUCTION INSTRUMENTATION USED FOR PROCESS CONTROL
-MAINTAINING REGULATORY COMPLIANCE OF UTILITY SYSTEMS AFFECTING PRODUCT QUALITY IN CONJUNCTION WITH THE MANAGER OF PLANT ENGINEERING SERVICES
-ASSIGNING A MANAGER/SUPERVISOR OF LABORATORY SERVICES WITH THE AUTHORITY AND RESPONSIBILITY OF:
.PROVIDING PRODUCT STERILITY TESTING AND MONITORING OF CONTRACT STERILIZERS
.ESTABLISHING AND MAINTAINING CONTROL OF THE PLANT ENVIRONMENTAL PROGRAM.
.APPROVING SITE HOUSEKEEPING PROGRAM AND PROCEDURES.
.APPROVAL OF PROCEDURES TO CONTROL AND MONITOR HYGIENE IN PRODUCTION AREAS
.APPROVAL OF PROCEDURES GOVERNING MICROBIAL MONITORING AND CONTROL OF PLANT OPERATIONS
.ROUTINE MONITORING OF CLEAN ROOM AIR QUALITY
.APPROVAL OF VALIDATION PROTOCOLS FOR PROCESSES IN WHICH MICROBIOLOGICAL CONTROL IS A SIGNIFICANT FACTOR
.ROUTINE MONITORING FOR MICROBIAL CONTAMINATION SOURCES IN THE PRODUCTION ENVIRONMENT FOR STERILE PRODUCTS, IDENTIFICATION OF THE CONTAMINATES WERE POSSIBLE, AND INVESTIGATION OF THEIR SOURCE
.APPROVAL OF STERILIZATION VALIDATION DOCUMENTATION
.ENSURING THAT APPROVED STERILIZATION PROCEDURES ARE PROVIDED WHERE NEEDED OR REQUIRED
.RESPONSIBLE FOR MAINTAINING AND IMPLEMENTING PROCEDURES TO ASSURE THAT THE REVIEW AND APPROVAL OF NEW AND CHANGED DOCUMENTS COMPLY WITH THE SYSTEMS OUTLINED IN THIS MANUAL. RESPONSIBLE FOR ASSURING THAT LABEL DEVELOPMENT AND GRAPHICS OPERATIONS ARE IN COMPLIANCE WITH APPLICABLE PROCEDURES.
MANAGER, PLANT ENGINEERING SERVICES RESPONSIBLE FOR:
-PROVIDING ADEQUATE FACILITIES AND EQUIPMENT FOR MANAGEMENT AND CONTROL OF PRODUCT QUALITY
-ENSURING THAT PROPER HOUSEKEEPING AND GENERAL MAINTENANCE ARE PERFORMED AS REQUIRED
-MAINTAIN A PROPER OPERATING ENVIRONMENT FOR PRODUCT MANUFACTURING
-PROVIDE MANUFACTURING MACHINERY AND MAINTENANCE SERVICE THAT MEETS QUALITY REQUIREMENTS
MANAGER, HUMAN RESOURCES
RESPONSIBLE FOR THE ASSESSMENT AND EVALUATION OF TRAINING NEEDS FOR THE ORGANIZATION AND PROVIDES THE APPROPRIATE RESOURCES FOR QUALITY TRAINING RECRUITS QUALIFIED PERSONNEL FOR ALL POSITIONS WITHIN THE ORGANIZATION. PROVIDES SAFETY AND MEDICAL SUPPORT TO MEET THE NEEDS OF THE ORGANIZATION.
MANAGER, PRODUCT DEVELOPMENT AND CUSTOMER SUPPORT RESPONSIBLE FOR:
-ENSURING THAT PRODUCT DESIGN AND PRODUCT DEVELOPMENT SYSTEMS MEET APPLICABLE REGULATORY AND SPECIFIED REQUIREMENTS
-DEVELOPING NEW PRODUCTS AND ENSURING THAT PRODUCT VERIFICATION AND DESIGN VERIFICATION PROCEDURES ARE ESTABLISHED
-ENGINEERING STERILIZATION AND PACKAGING TECHNOLOGIES AND ENSURING THAT THEY MEET APPLICABLE REGULATORY AND SPECIFIED REQUIREMENTS
-PROVIDING TECHNICAL SUPPORT TO CUSTOMERS BY ANALYZING AND TAKING CORRECTIVE ACTION TO RESOLVE PRODUCT DEFECTS AND PROVIDING IN-FIELD SUPPORT WHEN NECESSARY TO RESOLVE ISSUES OF PRODUCT APPLICATION AND FUNCTION
-TRAINING THE ENGINEERING ORGANIZATION ON APPLICABLE SPECIFICATIONS AND GUIDELINES
MANAGEMENT REPRESENTATIVE
-ENSURING THAT A QUALITY SYSTEM IS ESTABLISHED, IMPLEMENTED, AND MAINTAINED IN ACCORDANCE WITH REGULATORY REQUIREMENTS
-REPORTING ON THE PERFORMANCE OF THE QUALITY SYSTEM TO THE PLANT MANAGER/SITE DIRECTOR
-RECOMMENDING TO PLANT MANAGER/SITE DIRECTOR STOPPING PRODUCTION OR PRODUCT SHIPMENT AS WARRANTED IF QUALITY SYSTEM DEFICIENCIES OCCUR.
-APPOINTING A DEPUTY MANAGEMENT REPRESENTATIVE
-SUPPORT DESIGN CONTROL SYSTEM FOR COMPLIANCE WITH DOMESTIC AND INTERNATIONAL REGULATIONS
-PROVIDE LIAISON FOR MEDICAL DEPARTMENT
-PROVIDE LIAISON FOR REGULATORY AFFAIRS
MANAGER, MATERIALS MANAGEMENT
RESPONSIBLE FOR COORDINATION AND COMPLETION OF THE MONTHLY MASTER SCHEDULE; MAINTAINING THE PURCHASING RECORDS; PROVIDING THE PROPER HANDLING OF MATERIAL THROUGH RECEIVING, WAREHOUSING, AND SHIPPING, FOR THE ASSESSMENT OF SUB-CONTRACTORS AND FOR ASSURING THAT PRINTING OPERATIONS FOR CONTROLLED LITERATURE AND LABELS ARE IN COMPLIANCE WITH APPLICABLE PROCEDURES.
OPERATIONS MANAGER
EACH MANAGER IS RESPONSIBLE FOR:
-ENSURING THAT PROPER CONTROLS ARE IN PLACE TO MONITOR AND SUPPORT QUALITY PROGRAMS AND PROCEDURES
-ENSURING THE PROPER CONTROL OF MATERIAL THROUGHOUT THE MANUFACTURING PROCESS
-PROVIDING PROCESS CONTROL, PRODUCT IDENTIFICATION, AND TRACEABILITY, CORRECTIVE ACTIONS, AND IMPLEMENTING STATISTICAL TECHNIQUES, WHERE APPROPRIATE, THAT ARE SPECIFIED IN THE QUALITY SYSTEMS OUTLINED IN THIS MANUAL
-INITIATING ACTION TO PREVENT THE OCCURRENCE OF NONCONFORMITIES RELATING TO THE PRODUCT, PROCESS, AND PRODUCTION QUALITY SYSTEM
-INITIATING, RECOMMENDING, OR PROVIDING SOLUTIONS TO PRODUCTION QUALITY PROBLEMS
-THE MANUFACTURE OF THE PRODUCT IN ACCORDANCE WITH THE SPECIFIED REQUIREMENTS OF EN/ISO STANDARDS, WHERE APPLICABLE
-THE GENERATION OF SPECIFIED MANUFACTURING RECORDS
-THE CLEANING OF WORK SURFACES AND PRODUCTION EQUIPMENT
THERE ARE TWO OPERATIONS MANAGERS REPRESENTING THESE PRODUCTION AREAS:.
BUSINESS UNIT AND DIVISIONAL SUPPORT SERVICES
ALTHOUGH THE FOLLOWING SUPPORT SERVICES ARE NOT LOCATED AT THE CITY PLANT THEY ARE ASSIGNED TO THE PLANT FOR SUPPORT, GUIDANCE, AND OVERVIEW:
-MEDICAL AFFAIRS WITH THE RESPONSIBILITY TO APPROVE MEDICAL EFFICACY, SAFETY, AND CLINICAL USE OF THE PRODUCT
-REGULATORY AFFAIRS WITH THE RESPONSIBILITY TO FILE 510(K)'S AND REVIEW PRODUCT CHANGES FOR IMPACT ON AN EXISTING 510(K)
-PRODUCT COMPLAINT ANALYSIS FOR ACCS PRODUCTS IS CONDUCTED AT AND WHO ARE THE FORMALLY DESIGNATED UNIT FOR PRODUCT COMPLAINTS
-DOMESTIC MARKETING AND SALES WHO PROVIDE INITIAL CUSTOMER SUPPORT AND IN-SERVICING OF CUSTOMERS ON FIRST TIME INTRODUCTION OF PRODUCTS
-INTERNATIONAL MARKETING AND SALES, AND AFFILIATES WHO ARE INTEGRAL IN THE PRODUCT COMPLAINT PROCESS FOR PRODUCTS SOLD INTERNATIONALLY
THE RESPONSIBILITIES OF THESE ORGANIZATIONS ARE SPECIFIED IN CONTROLLED PROCEDURES.
4.1.2.2 RESOURCES
THE PLANT MANAGER HAS RESPONSIBILITY FOR ASSURING THAT ALL ACTIVITIES DESCRIBED IN THIS MANUAL ARE CARRIED OUT IN AN APPROPRIATE MANNER AND THAT THOSE RESPONSIBLE FOR CARRYING OUT THESE ACTIVITIES HAVE THE PROPER TRAINING AND RESOURCES TO ACCOMPLISH THESE TASKS.
HUMAN RESOURCE SKILLS THAT ARE ESSENTIAL TO THE IMPLEMENTATION OF THE QUALITY POLICY AND THE ACHIEVEMENT OF QUALITY OBJECTIVES ARE:
-MICROBIOLOGIST / CHEMIST
-MARKETING / SALES REPRESENTATIVE
-MEDICAL AFFAIRS REPRESENTATIVE
-MANUFACTURING PROCESS ENGINEER
-PRODUCT DEVELOPMENT ENGINEER
-SAFETY ENGINEER
-MANUFACTURING SUPERVISION
-QUALITY ASSURANCE ENGINEER / SUPERVISORS
-FACILITIES / UTILITIES ENGINEER
-EQUIPMENT ENGINEER
-EQUIPMENT MAINTENANCE SUPERVISION
-GMP / REGULATORY AFFAIRS COMPLIANCE OFFICER
-PACKAGING / STERILIZATION ENGINEER
-CALIBRATION / INSTRUMENTATION SERVICE
-SOFTWARE / SYSTEM NETWORK ENGINEER OR PROGRAMMER
-PRODUCT COMPLAINT ANALYST / STATISTICIAN
-QUALITY ASSURANCE INSPECTORS / TECHNICIANS
PERSONNEL WHO MEET THE REQUIREMENTS FOR THE POSITION AS DESCRIBED IN THE APPROPRIATE JOB DESCRIPTION ARE UTILIZED IN THESE POSITIONS. THEY ARE QUALIFIED FOR THEIR POSITION THROUGH A COMBINATION OF ACADEMIC TRAINING, ON THE JOB TRAINING, WORK EXPERIENCE, AND PERSONAL IMPROVEMENT THROUGH COURSES TAKEN AS A PART OF THE QUALITY COLLEGE PROGRAM. THESE PERSONNEL MAY BE RESIDENT ON SITE, CONSULTANTS, OR LOCATED AT OTHER FACILITIES WITH RESPONSIBILITY TO SUPPORT OPERATIONS.
4.1.2.3 MANAGEMENT REPRESENTATIVE
THE PLANT MANAGER HAS THE RESPONSIBILITY AND AUTHORITY TO APPOINT A MANAGEMENT REPRESENTATIVE FROM THE PLANT MANAGEMENT ORGANIZATION, WHO, IN COMBINATION WITH OTHER RESPONSIBILITIES, HAS THE RESPONSIBILITY AND AUTHORITY TO ENSURE THAT A QUALITY SYSTEM IS ESTABLISHED, IMPLEMENTED, AND MAINTAINED IN ACCORDANCE WITH REGULATORY REQUIREMENTS; TO PROVIDE THE PLANT MANAGEMENT STAFF WITH A PERIODIC REVIEW OF THE QUALITY SYSTEM; AND TO DOCUMENT THE MANAGEMENT REVIEW OF THE QUALITY SYSTEM. THE PLANT MANAGER HAS APPOINTED THE MANAGER OF QUALITY SYSTEMS AS THE MANAGEMENT REPRESENTATIVE.
4.1.3 MANAGEMENT REVIEW
IT IS MANAGEMENT'S RESPONSIBILITY TO ESTABLISH QUALITY POLICY, OBJECTIVES, AND RESPONSIBILITIES, AND TO IMPLEMENT THEM THROUGH QUALITY PLANNING, QUALITY CONTROL, AND QUALITY IMPROVEMENT.
THE OBJECTIVES FOR MEETING CUSTOMER NEEDS, QUALITY GOALS, AND REGULATORY COMPLIANCE WILL BE DEFINED ANNUALLY BY THE PLANT MANAGER/QA MANAGER AND SENIOR STAFF. CAREFUL CONSIDERATION IS GIVEN TO HOW THESE OBJECTIVES DETERMINE THE PLANT DIRECTION AND HOW THE QUALITY SYSTEM IS EVALUATED FOR SUITABILITY AND EFFECTIVENESS. THE MANAGEMENT REVIEW ADDRESSES ISSUES SUCH AS PRODUCT FITNESS FOR USE, PERFORMANCE, SAFETY, AND DEPENDABILITY. CONSIDERATION IS GIVEN TO MINIMIZING QUALITY COSTS AND QUALITY LOSSES. THE PURPOSE OF THE MANAGEMENT REVIEW IS TO ENSURE THAT EMPHASIS IS PLACED ON PROBLEM PREVENTION RATHER THAN DEPENDENCE ON DETECTION AFTER OCCURRENCE.
REFERENCE DOCUMENTS:
4.2QUALITY SYSTEM
4.2.1GENERAL
THIS DOCUMENT IS THE QUALITY MANUAL. IT COVERS THE REQUIREMENTS OF ISO 9001: 1994 AND REFERENCES THE QUALITY SYSTEM PROCEDURES AND OUTLINES THE STRUCTURE OF THE DOCUMENTATION USED. IS REGISTERED TO I.S. EN ISO 9001: 1994; REGISTRATION xxxx, AND I.S. EN 46001: 1994; REGISTRATION # xxxx. ’S MEDICAL DEVICE REGISTRATION NUMBER IS xxxx
4.2.2QUALITY SYSTEM PROCEDURES
A DOCUMENTED QUALITY SYSTEM EXISTS. THE SPECIFIED REQUIREMENTS ARE CONTAINED IN THE FOLLOWING DOCUMENTATION.
-QUALITY MANUAL PRC-1000-0008
-DIVISION POLICIES AND GUIDELINES
-BASIC OPERATING PROCEDURES
-DESIGN HISTORY RECORDS
-DEVICE MASTER RECORDS
-EXCEPTION DOCUMENTS
-PRODUCT DEVELOPMENT REVIEWS
-INCOMING, IN-PROCESS, AND FINAL PRODUCT ASSEMBLY, INSPECTION, AND ACCEPTANCE SPECIFICATIONS
-ESSENTIAL REQUIREMENTS OF MDD/93/42/EEC
-PRODUCT TECHNICAL FILES
-PRODUCT DESIGN DOSSIER
-PRODUCT DESIGN HISTORY FILES
4.2.3 QUALITY PLANNING
DOCUMENTS EXIST WHICH DEFINE QUALITY PLANNING, WHICH INCLUDES PLANNING AT THE SYSTEM LEVEL AND AT THE PRODUCT LEVEL.
MANAGEMENT HAS ADDRESSED THE NEED TO MAINTAIN POSITION IN AN EVER INCREASING COMPETITIVE ENVIRONMENT. THE NEED TO IMPLEMENT A PROGRAM WHICH EVALUATES THE NEEDS AND GOALS OF LABORATORIES, OPERATIONS AND WILL DEFINE AND TRACK THOSE GOALS HAS BEEN DEVELOPED TO TRACK THIS CONTINUOUS IMPROVEMENT. THE CONTINUOUS IMPROVEMENT PLAN IS CREATED BY AND FULLY SUPPORTED BY THE MANAGEMENT TEAM.
PLANS FOR PRODUCT QUALITY ARE DEFINED IN THE PROCEDURE FOR "DEVICE MASTER RECORDS". THE QUALITY PLANS FOR PRODUCT ARE SPECIFICALLY DEFINED IN THE WORK ORDER RECORDS. THE WORK ORDER RECORD CONTAINS INFORMATION WHICH OUTLINES THE STEPS FOR MANUFACTURE. ITS PURPOSE IS TO AUTHORIZE, TRACE, AND RECORD THE VARIOUS ACTIVITIES ASSOCIATED WITH THE MANUFACTURE OF PRODUCT. RESPONSIBILITY AND AUTHORITY FOR MAINTAINING AND UPDATING THE DEVICE MASTER RECORD IS MULTI-DISCIPLINARY (I.E. SHARED AMONG ENGINEERING, MANUFACTURING, DOCUMENT CONTROL, AND QUALITY ASSURANCE, AS NECESSARY).
REFERENCE DOCUMENTS:
SECTION 4.3 CONTRACT REVIEW
4.3.1GENERAL
MASTER SCHEDULE DEVELOPMENT IS COORDINATED BETWEEN THE PLANNING AND MANUFACTURING FUNCTIONS THROUGH MONTHLY SCHEDULING MEETINGS WITH REVIEW BY MANAGEMENT. STANDARD PRODUCTS ARE BUILT TO STOCK AND ARE PURCHASED BY THE END USER "OFF THE SHELF". OTHER INTERNAL FACILITIES MAY ALSO ORDER PRODUCT COMPONENT PARTS FOR USE IN FINISHED PRODUCTS BASED ON THE COMMODITY SPECIFICATION.
4.3.2REVIEW, 4.3.3 AMENDMENT TO CONTRACT, AND 4.3.4 RECORDS
CONTRACT REVIEW FOR EXTERNAL CUSTOMERS IS LIMITED TO MADE TO ORDER PRODUCTS. THE CUSTOMER SUBMITS A PURCHASE ORDER TO THE BUSINESS UNIT: CONTRACTS AND PRICING. THE PURCHASE ORDER IDENTIFIES THE AGREED UPON PRICE, CONTRACT QUANTITY, AND DELIVERY SCHEDULE. PROCEDURE FOR THE CREATION OF A MADE TO ORDER WORK ORDER IS DEFINED IN APPLICABLE PROCEDURES. THE MADE TO ORDER PROCESS ALLOWS THE CUSTOMER TO RECEIVE A PRODUCT BUILT TO A CONFIGURATION APPROVED BY THE CUSTOMER, AND ALLOWS FOR AMENDMENTS TO THE CONTRACT IF REQUIRED. PROCEDURES DEFINE THE CONTRACT REVIEW RECORDS TO BE MAINTAINED.
REFERENCE DOCUMENTS:
SECTION 4.4 DESIGN CONTROL
4.4.1 GENERAL
A DEFINED PRODUCT DEVELOPMENT PROCESS EXISTS. DESIGN AND VERIFICATION ACTIVITIES ARE APPROPRIATELY PLANNED. THE DESIGN CONTROL FUNCTION MAY OCCUR AT AN FACILITY OTHER THAN CITY WITH CONCURRENT PLANNING, INTERFACES, INPUT, AND REVIEW BETWEEN FACILITIES. OPERATING PROCEDURES ARE IN PLACE TO PROVIDE CONTROL OF THE PRODUCT DESIGN, AND TO VERIFY THAT THE DESIGN MEETS THE SPECIFIC REQUIREMENTS INCLUDING THOSE FOR MEDICAL DEVICE SAFETY AND TO ENSURE THAT TIMELY COMMUNICATIONS BETWEEN DISCIPLINES OCCUR. DESIGN DOCUMENTATION IS MAINTAINED BY THE APPROPRIATE ENGINEERING MANAGER OR DESIGNEE.
4.4.2 DESIGN AND DEVELOPMENT PLANNING
PRODUCT DESIGN AND DEVELOPMENT PLANNING IS ACCOMPLISHED BY THE INTERACTION BETWEEN TEAM MEMBERS AND THE PUBLICATION OF A DEVELOPMENT PLAN DETAILING THE MILESTONES NECESSARY TO ACHIEVE PRODUCT APPROVAL. THE DEVELOPMENT PLAN IS PERIODICALLY UPDATED TO REFLECT CHANGING PRIORITIES AND TECHNICAL DIFFICULTIES ENCOUNTERED DURING DEVELOPMENT.
4.4.3 ORGANIZATIONAL AND TECHNICAL INTERFACES
THE PRODUCT DEVELOPMENT PROCESS PROVIDES FOR THE DEFINITION OF TEAM MEMBERS, THEIR RESPONSIBILITIES, AND THE INTERFACE BETWEEN GROUPS. REQUIRED DOCUMENTATION AND REVIEWS ARE SPECIFIED.
4.4.4 DESIGN INPUT
DESIGN REQUIREMENTS ARE IDENTIFIED, DOCUMENTED, AND REVIEWED AS APPROPRIATE FOR COMPLETENESS, CLARITY, AND CONFLICTS PER APPLICABLE PROCEDURES. MEDICAL DEVICE SAFETY REQUIREMENTS ARE INCLUDED IN THE DESIGN INPUT.
4.4.5 DESIGN OUTPUT
COMPLETED DESIGNS ARE DOCUMENTED AS APPROPRIATE BY DRAWINGS, PROCEDURES, SPECIFICATIONS AND STANDARDS. DESIGNS ARE REVIEWED TO VERIFY THAT THE DESIGN INPUT REQUIREMENTS HAVE BEEN MET, INCLUDING ALL APPLICABLE REGULATORY REQUIREMENTS. DESIGNS ARE REVIEWED TO VERIFY THE SAFE AND PROPER FUNCTIONING OF THE PRODUCT.
4.4.6 DESIGN REVIEW
AT THE COMPLETION OF SIGNIFICANT PHASES OF PRODUCT DESIGN A MANAGEMENT REVIEW IS CONDUCTED TO APPROVE THE DESIGN EVOLUTION. RECORDS OF THE DESIGN REVIEW ARE DOCUMENTED.
4.4.7 DESIGN VERIFICATION
EACH DESIGN IS EVALUATED, CHECKED, AND APPROVED BY QUALIFIED INDIVIDUALS. DESIGN VERIFICATION TESTING IS PERFORMED TO DEMONSTRATE THAT THE PRODUCT AND/OR PROCESS CONFORMS TO DESIGN REQUIREMENTS. RECORDS ARE CREATED AND MAINTAINED FOR ALL DESIGN VERIFICATION ACTIVITIES INCLUDING CLINICAL INVESTIGATION.
4.4.8 DESIGN VALIDATION
VALIDATION OF THE PRODUCT IS PERFORMED TO ENSURE THAT THE PRODUCT MEETS END USER REQUIREMENTS.
4.4.9 DESIGN CHANGES
PROCEDURES DEFINE THE PROCESS THAT DOCUMENTS AND CONTROLS CHANGES MADE TO DESIGNS AND THE APPROPRIATE APPROVALS NECESSARY FOR CHANGES AND MODIFICATIONS. WHEN CHANGES ARE MADE TO PREVIOUSLY MARKETED PRODUCTS, PROCEDURES EXIST TO DESCRIBE THAT PROCESS.
4.4.10DESIGN TRANSFER
THE DESIGN TRANSFER PROCESS IS USED TO PROVIDE FOR THE SUCCESSFUL TRANSFER OF THE PRODUCT DESIGN TO THE MANUFACTURING STATION. THIS PROCESS ASSURES THAT THE DEVICE IS CORRECTLY TRANSLATED INTO PRODUCTION SPECIFICATIONS.
4.4.11DESIGN HISTORY FILE
ALL PRODUCT FAMILIES ARE ASSIGNED A DESIGN HISTORY FILE. A NEW DESIGN HISTORY FILE MAY BE INITIATED AT THE BEGINNING OF A NEW PRODUCT DEVELOPMENT PROJECT IF AN EXISTING FILE DOES NOT ALREADY COVER IT. THE DESIGN HISTORY FILE IS CLOSED OUT AT THE COMPLETION OF THE PROJECT, BUT MAY BE AMENDED AS NECESSARY AFTER THAT TO KEEP THE FILE CURRENT. A DESIGN HISTORY FILE IS A COMPILATION OF THE RECORDS, WHICH DESCRIBE THE DESIGN HISTORY OF A DEVICE.
REFERENCE DOCUMENTS:
SECTION 4.5 DOCUMENT AND DATA CONTROL
4.5.1 GENERAL
A FORMAL DOCUMENTATION SYSTEM EXISTS WHICH PROVIDES FOR THE CONTROL OF ALL QUALITY RELATED DOCUMENTS. QUALITY RECORDS WHICH ARE CONTROLLED ARE QUALITY ASSURANCE TESTING RECORDS, ENGINEERING VALIDATION REPORTS, WORK ORDER DOCUMENTS, NON-CONFORMANCE REPORTS, ENGINEERING LABORATORY NOTEBOOKS, CLINICAL SURVEYS, CALIBRATION REPORTS, ETC.