SBS - The best value in QMS software

Do Process gauges need to be in Calibration control system?

J

J. Kay

#1
My company is preparing to upgrade our ISO system to QS-9000. There is difference of opinion as to whether process gauges (i.e. pressure, temperature, rpm, etc.) are to be included in the gauge control system (calibration / verification). We are a raw material compounder and all product is accepted or rejected in a laboratory. Has anyone experienced problems with registration to QS-9000 where process gauges were not in the gauge control system?
 
Elsmar Forum Sponsor

Howard Atkins

Forum Administrator
Staff member
Admin
#2
I believe that if the gauges are used as an indication of the process and not to qualify the product then they do not need to be calibrated.
If you are performing SPC on the process and using these gauges then they ned to be calibrated.
What does the machinery book say about these gauges?
 
#3
I fought this battle many times; and lost every time.
The standard reply from an auditor is "If you don't need the gauges, then why do you have them in the process?"
If the gauge is not part of the machine and you really don't need it, then remove it.
If the gauges are part of the machine,i.e., extrusion presses, then the mfg put them there for a purpose;to controll the process.
Rule of thumb:
Any item that is used to verify, validate or otherwise used to indicate the quality of the product/process is required to be controlled.
 
Thread starter Similar threads Forum Replies Date
M Do we need to calibrate gauges on process equipment? General Measurement Device and Calibration Topics 18
D Using "Particle Size Standard" templates as gauges - How to avoid giving a gauge # while using for process control? General Measurement Device and Calibration Topics 2
B Toyota PPAP Process - Three Questions APQP and PPAP 3
R Changes vs CMO - How can we simplify this process? Supplier Quality Assurance and other Supplier Issues 3
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2
V Laser Welding Process - Impact on Electrical Properties Reliability Analysis - Predictions, Testing and Standards 4
Q Process: Knowledge Section 7.1.6 of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
L Documented Information in Internal Audits Process (9.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Sampling plan for in-process QC (medical devices) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
R MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
M Clinical Benefit of device that only aids in a process for managing or treating disease EU Medical Device Regulations 2
C In-process inspection - Tooling and assembly lines for automotive companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Efficacy of an IT process after a cyber attack ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
N Riveting - special process Manufacturing and Related Processes 11
M Material incoming to the production process reflected in PFMEA FMEA and Control Plans 9
A API Spec Q1 Purchasing Process - Supplier Reevaluation based on Supplier Risks 5.6.1.4 Oil and Gas Industry Standards and Regulations 15
B Handling lower detection limits for SPC and process performance Statistical Analysis Tools, Techniques and SPC 1
D Measurables for Plastic Injection molding process Manufacturing and Related Processes 1
S Cleaning process center change ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
R Inspection and Work order process Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
A How to reduce the process SPC monitoring Capability, Accuracy and Stability - Processes, Machines, etc. 3
John Predmore Configuration Management as a process instead of a procedure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
R PCBA process validation Qualification and Validation (including 21 CFR Part 11) 2
U Internal Auditor not trained but done Audit for some process Nonconformance and Corrective Action 5
B Two excellent examples of process capability analysis from Quality Magazine Capability, Accuracy and Stability - Processes, Machines, etc. 5
D ECO (Engineering Change Order) process questions ISO 13485:2016 - Medical Device Quality Management Systems 7
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
Pau Calvo Quality Management process is mandatory in ISO9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Tagin Template or Checklist for Process Change Document Control Systems, Procedures, Forms and Templates 5
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 9
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
J Process FMEA Template with examples - Cold and Hot Forged components FMEA and Control Plans 4
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 6
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
A Validation of Forced Aeration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
R Error Proofing Label process Manufacturing and Related Processes 4
B New Release of CQI-12 Coatings Process (Revision 3- Release date- 7/2020) Customer and Company Specific Requirements 2
D Layered Process Audits - FCA 9.2.2 - Exemption Clause? IATF 16949 - Automotive Quality Systems Standard 5
B ISO 11607-2 "Critical Parameter" vs. "Process Parameter" Other Medical Device Related Standards 6
Q Example Process orientation to the process leadership, management, goals (tasks of the top management) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Process Inspection -Sub assembly process inspection sheet Lean in Manufacturing and Service Industries 3
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11

Similar threads

Top Bottom