Preventive Maintenance Interpretation - Clause 4.9.g.1

D
#1
Can someone please interpret for me?
"The requirements for any qualification of process operations, including associated equipment and personnel (see 4.18), shall be specified.

Such processes requiring pre-qualification of their process capability are frequently referred to as special processes.

Records shall be maintained for qualified processes, equipment and personnel, as appropriate. (see 4.16).

QS standard - I think I missed the boat with this at Assesement. He didn't look at it. I'm not sure I'm covered or not, cuz I'm not sure what they are looking for.
Thanks ahead for all your help!!!
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
Thgis just says you have to document your qualification plan with details such as "...associated equipment and personnel..."

The question to you is do you have any 'special' processes?
 
J

jjolly

#3
As long as we are talking about 4.9, could you help me with an interpretation? "The supplier shall identify and plan the production, installation and servicing process which directly affect quality and shall ensure that these processes are carried out under controlled conditions. Controlled conditions shall include the following: c) compliance with references standards/codes, quality plans and/or documented procedures." This is where my question lies. What reference standards/codes are we talking about. We have our interpretations of this but would like some out side input to help clear it up.
 
R

Roger Eastin

#4
I believe this means if, for instance, a gov't agency (FAA,DOT,FDA,etc) "imposes" some sort of standard or code that you must meet to make your product (or service), then you must account for that in your process. It most likely would occur in your work or test methods, with at least, a reference to the particular standard of interest.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#6
Prior to manufacturing a product, a company typically 'qualifies' the manufacturing process in some way. Often in the 'old world' the plans were not have been documented - either in a proposed plan or in maintainined records of the results. Now days you write up a qualification plan. This may include capability calculations, run at rate and other specifics. You could also call this Process Validation - you set everything up and make product for a pre-defined time and/or quantity and/or goal state.

In the QS world, they use the APQP model for product life. In APQP there are a lot of qualification schemes starting with equipment manufacturers. The end of the INITIAL qualification is the PPAP. I emphasize 'initial' as you may make process changes which may trigger a PPAP.

There is also qualification of special processes which is really the same thing (documented plan) except involves destructive testing - remember that Special Proceses are those where there is a critical / special characteristic which cannot be verified except in a destructive test.
 
Thread starter Similar threads Forum Replies Date
S Are there ISO9001:2015 Requirements for Preventive Maintenance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
D Preventive Maintenance Implementation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Minitab tool to evaluate PM (Preventive Maintenance) process Using Minitab Software 6
M Preventive Maintenance Spreadsheet in Excel Quality Assurance and Compliance Software Tools and Solutions 2
E Manufacturer Responsibility (vs. User/Customer) for Preventive Maintenance/Repair 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Assessing a Preventive Maintenance Strategy - Reliability or Maintenance Statistics Reliability Analysis - Predictions, Testing and Standards 2
S How to determine Preventive Maintenance and Calibration Grace Periods General Measurement Device and Calibration Topics 4
R A GRP model that also considers the Preventive Maintenance Efficiency Reliability Analysis - Predictions, Testing and Standards 3
M Tracking Preventive Maintenance Effectively Nonconformance and Corrective Action 5
R Preventive Maintenance Checks Advice Manufacturing and Related Processes 4
M TS 16949 Clause 7.5.1.4 Preventive and Predictive Maintenance - Requirements Scope IATF 16949 - Automotive Quality Systems Standard 3
M Preventive Maintenance & Operating Procedures for Measurement Equipment Inspection, Prints (Drawings), Testing, Sampling and Related Topics 20
S Which ISO/AS Clause directly relates to Preventive Maintenance of Equipment? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
T Preventive Tool Maintenance - Preventive and Predictive Maintenance requirements Manufacturing and Related Processes 7
R Free Preventive Maintenance Software Manufacturing and Related Processes 3
S NC Lathe Preventive Maintenance Boiler Plate checklist Reliability Analysis - Predictions, Testing and Standards 3
E Meeting AS9100 Clause 6.3 Infrastructure Requirements - Preventive Maintenance AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
S Does overdue preventive maintenance require an evaluation on product quality? ISO 13485:2016 - Medical Device Quality Management Systems 5
C Benchmarking Preventive Maintenance Sales Benchmarking 0
Q ISO 9001 Clause 6.3 Infrastructure - Preventive Maintenance Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
M Preventive Maintenance Scheduling Software recommendations Lean in Manufacturing and Service Industries 8
L Any ideas for Preventive Maintenance checklist? Quality Manager and Management Related Issues 5
D How to interpret TS Clause 7.5.1.4 Preventive and Predictive Maintenance? IATF 16949 - Automotive Quality Systems Standard 8
R Who runs your Preventive Maintenance Program? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 45
G Preventive Maintenance for Assembly Line Bar-Code & General Printers - Necessary? IATF 16949 - Automotive Quality Systems Standard 4
M Definition Predictive Maintenance vs Preventive Maintenance - Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
D Definition Preventive Maintenance vs. Predictive Maintenance - Distinction between Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 20
Crusader Preventive Maintenance - Electronic Records Deleted/Erased OR Are Records Required? Records and Data - Quality, Legal and Other Evidence 62
I Preventive Action Examples, Excluding Preventive Maintenance, Wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K Calibration - Not willing to spend money in calibration/preventive maintenance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
B Preventive Maintenance Program in a non-production facility Misc. Quality Assurance and Business Systems Related Topics 4
S Looking for Equipment Specific Preventive Maintenance templates/Procedures/forms Document Control Systems, Procedures, Forms and Templates 8
G Preventive Maintenance Requirements - ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 70
H Preventive Maintenance - Does anyone have a sample of a PM procedure? Document Control Systems, Procedures, Forms and Templates 5
Marc Definition Preventive Maintenance - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
Randy Preventive and Corrective Maintenance - Looking for a basic procedure Document Control Systems, Procedures, Forms and Templates 19
S Definition Predictive vs. Preventive Maintenance - TS 16949 Clause 7.5.1 - Definitions of Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 32
N 3% of the scheduled preventive maintenance (PMs) cancelled - You make the call! Preventive Action and Continuous Improvement 11
A Preventive maintenance outsourcing - What type of controls? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R Definition Preventive vs. Predictive Maintenance - What is the difference? TS 16949 - 7.5.1.4. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 11
F Preventive and Predictive Maintenance - Benchmarking Partner Benchmarking 6
V Can an Ionizer be calibrated or perform preventive maintenance when in use? General Measurement Device and Calibration Topics 6
V Does preventive maintenance have any positive effect on smart transmitters? General Measurement Device and Calibration Topics 1
Marc Preventive Maintenance - Suppliers & Delivery Vehicles ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
F QS-9000 Clause 4.9.g.1 - Preventive Maintenance - Tool Wear Predictive Maintenance QS-9000 - American Automotive Manufacturers Standard 1
Marc Preventive Maintenance & Machine Manual Control QS-9000 - American Automotive Manufacturers Standard 0
M Preventive and Predictive Maintenance - Information on procedures relating to 4.9.g.1 QS-9000 - American Automotive Manufacturers Standard 16
C If it doesn't prevent a non-conformance, is it a preventive action? IATF 16949 - Automotive Quality Systems Standard 13
R Evaluating the need for preventive action Preventive Action and Continuous Improvement 3
GURU SDI Rust preventive oil mixed with kerosene Problem Solving, Root Cause Fault and Failure Analysis 2
Similar threads


















































Top Bottom