Differentiating between Process and Product Characteristics in Control Plans

C

charly

#1
Process and Product Characteristics

Any body have a good rule of thumb for differentiating between process and product characteristisc in finished goods control plans?
 
Elsmar Forum Sponsor
Q

qualimanagain

#2
Charly:

As far as I understand, process characteristics are properties taken from the machine where the finished good was produced, example: speed, pressure, temperature, reaction times, etc. and PRODUCT characteristics are properties or indicators related to the product or material, such as: dimensions, viscosity, hardness, weight, etc.

Normally the product KC's will be "tied" or linked to some of the process KC. If you do not control your process you would face problems with your product.

Hope to be helpful:

Qualiman
 
Thread starter Similar threads Forum Replies Date
B Differentiating between "Review of Requirements" and "Contract Review" AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
T Difference between a subcontractor and a supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
K %GRR was between 10-30% so we have to have a "backup plan" per auditor IATF 16949 - Automotive Quality Systems Standard 15
H Difference between Stainless Steel 316 ASTM F899 and ASTM A276 Other Medical Device Related Standards 1
A Exact terms for a plating failure and difference between rejection rate and failure rate Manufacturing and Related Processes 9
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 15
M Difference between MSA and MSE? General Measurement Device and Calibration Topics 1
G What is the difference between discrete and continuous variables? Problem Solving, Root Cause Fault and Failure Analysis 5
R Plea for advice on transitioning between Notified Bodies (label updates) Medical Device and FDA Regulations and Standards News 1
M Measuring FIM (TIR) - Two inside diameters - Conflicting readings between inspectors Manufacturing and Related Processes 1
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 2
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
Jimmy123 What is the difference between Error Proofing and Controls? ISO/IATF 16949 - Control Plans FMEA and Control Plans 16
DuncanGibbons Clear differences between ISO 13485 and AS 9100D requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
H What is different between PED certificate and CPR certificate? Manufacturing and Related Processes 2
B Angle between two surfaces Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
D Variation between Faro Arms Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
K Differences between Manufacturing Process Audit & Layered Process Audit Lean in Manufacturing and Service Industries 4
P Risk acceptability alignment between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 6
C IEC 60601-1-8, difference between table 4 and annex D IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Reorganizing responsibilities between management teams and Employees in them ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Compatibility between MDD and MDR devices EU Medical Device Regulations 7
Q How should I analyze measurement correlation between me and customer? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
S Relationship between IEC 62304 problem resolution and ISO 13485 IEC 62304 - Medical Device Software Life Cycle Processes 8
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 5
T Something between a manual and a procedure? Document Control Systems, Procedures, Forms and Templates 9
Q What is the difference between AS9100D 9.3.2.f and 9.3.3.a AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
S Differences in CB expectations between the US and Europe Registrars and Notified Bodies 3
Ahang Separation between secondary circuit and accessible parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Aluminum - What is the difference between 6061-T6 and 6061-T651 (both per ASTM B211)? Manufacturing and Related Processes 4
G Comparing Gauge Blocks - Translating the calibration between the master set and the QA set General Measurement Device and Calibration Topics 2
R The alignments and contradiction in Quality Engineering and management between the Automotive and Aerospace industry AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
F IEC 62304 - Segregation and communication between software items IEC 62304 - Medical Device Software Life Cycle Processes 1
E Discussion between co-worker on tolerance and uncertainty and how to apply it. Thoughts? 17025 ISO 17025 related Discussions 1
L Comparison matrix between IATF 16949:2016 to ISO 12207, ISO 9001 and Automotive SPICE IATF 16949 - Automotive Quality Systems Standard 3
M Applicability of IEC 60950-1 Table K2 - Minimum clearances between circuits Various Other Specifications, Standards, and related Requirements 0
J Deciding between Professional Use or Lay Person IVD Test - Human fecal stool specimens Other Medical Device and Orthopedic Related Topics 1
S Is there any connection between PFMEA and Acceptance Plan FMEA and Control Plans 1
D Link between FMEA, flow chart and control plan FMEA and Control Plans 10
M What are the differences between "Process Flowchart form" and "Process Flow Diagram form"? IATF 16949 - Automotive Quality Systems Standard 4
L Connection between IEC 62304 and Chapter 14 of IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P What is the exact difference between Risk and Opportunity in context of ISO 27001? IEC 27001 - Information Security Management Systems (ISMS) 7
S Difference between Surface Finish (Ra) and Flatness (GD&T) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
K Differences between EN ISO 11607-1:2009 vs. 2017 Other Medical Device Related Standards 1
M What are the differences between TIR 13004:2013 and TIR 33? Other Medical Device Related Standards 2
O Which part of ISO 14644 describe how can I classify cleanrooms between them? Other ISO and International Standards and European Regulations 0
O Air Flow - Which is the operational difference between LAF (vertical and horizontal) and RLAF? Manufacturing and Related Processes 2
Q Choosing between ISO 9001 (2015) & TL 9000 certifications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Connection between Technical File and Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
Similar threads


















































Top Bottom