Establishing and controlling process capability - Meaning of Phrases

D

D.Salman

#1
#1
Dear All,
I’m a bit confused about the meaning of the following phrases?
1.The process is capable of yielding conforming service.
2.The process actually meets the requirements?
Any help will be appreciated.
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
bobdoering

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#2
#2
Re: Establishing and controlling process capability

D.Salman said:
Dear All,
I’m a bit confused about the meaning of the following phrases?
1.The process is capable of yielding conforming service.
2.The process actually meets the requirements?
Any help will be appreciated.
Click to expand...
A process in control is in the ideal state 100% conforming and predictable
-must remain stable over time
-must operate in a stable and consistent manner
-must be set at the proper level
-the natural process spread must not exceed the product’s specified tolerance

In essence, both of your statements are looking for the same results - the ideal process always yields the correct results (within specification), and can be proven to do so.
 
T

Tom Slack

#3
#3
These terms mean something very specific in the Quality field.

The word "capable" means if the process is stable, it will yield adequate results. Variability is the most important issue. For example, if specifications specify a variance of of 2 or less and the process has a variance of 4, we know there no use in attempting to use this process. In this case, we say the process is not capable. An engineer that tries to use the process by adjusting the set point is in for a great deal of frustration!

Even the phrase "Meets the requirements" is not as simple as it seems. The question is: whose requirements? This may be part of a Quality Function Deployment discussion. This phrase could also be a part of a discussion concerning "fitness for use", which is a Juran concept.

I hope this puts you in the right direction!

Best wishes,

Tom
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A Help establishing regulatory requirements - Plastic dental cartridge syringe US Food and Drug Administration (FDA) 0
K ISO 13485 section 5.3 Quality Policy - No framework for establishing and reviewing quality objectives ISO 13485:2016 - Medical Device Quality Management Systems 2
N Use part of high risk device for establishing low risk device EU Medical Device Regulations 0
J ISO 13485:2016 Section 6.2 - Documenting the process for establishing competence ISO 13485:2016 - Medical Device Quality Management Systems 6
M Establishing a FTQ (First Time Quality) process for an engine assembly line Quality Tools, Improvement and Analysis 1
R Establishing the quality policy for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
N Establishing a monthly scrap cost target Lean in Manufacturing and Service Industries 11
T Establishing -F- datum - need advice Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
S Establishing a Gage R&R Studies Program in a Testing Laboratory Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
M Establishing traceability from calibrated glassware to non calibrated ones General Measurement Device and Calibration Topics 5
O Establishing SPC for small batches of 10-15 units Statistical Analysis Tools, Techniques and SPC 10
M Establishing Metrics - Where do you document metrics? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
alonFAI Establishing a Receiving Inspection Procedure Document Control Systems, Procedures, Forms and Templates 5
optomist1 Establishing Sigma or Capabilty Indices for Automotive Safety Quality Tools, Improvement and Analysis 1
S Establishing an MSA Plan and Justification Suggestions wanted Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
M Establishing a QMS - What Daily/Weekly/Monthly activities in Auto Industry IATF 16949 - Automotive Quality Systems Standard 4
T Help establishing a good Customer Complaints Procedure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V Process Validation Guidance establishing the Integration with QbD - April 2012 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
M Establishing Ranges for Weights for Calibration Verification of a Micro-Balance Calibration Frequency (Interval) 1
D Preparing for ISO 29001/API Q1- Establishing Control Features Oil and Gas Industry Standards and Regulations 3
D Establishing Key Process Characteristics (KPC's) Quality Tools, Improvement and Analysis 6
C New Quality Manager - Establishing Teams in different Business Units Quality Manager and Management Related Issues 4
H Noob Frequency Distribution and establishing achievable goals Using Minitab Software 2
K How to apply IEC 62366 and what shall be changed in establishing a Technical File ISO 13485:2016 - Medical Device Quality Management Systems 2
M Establishing monthly production targets with varying number of employees Lean in Manufacturing and Service Industries 6
A Why do I need batch size in establishing control plan to certain AQL?? AQL - Acceptable Quality Level 4
E Need help establishing a DMR (Device Master Record) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Basis for Establishing Gage Tolerancing - "Gage Maker's Tolerances" General Measurement Device and Calibration Topics 4
K Establishing the Environmental Aspects and Impacts for a Septic Tank Miscellaneous Environmental Standards and EMS Related Discussions 5
M Establishing simple procedure and work instruction using chart or photo or video Document Control Systems, Procedures, Forms and Templates 2
L Criteria for Establishing Control Plan Sample Size and Inspection Frequency FMEA and Control Plans 7
K Inventory Management - Establishing a procedure for Inventory Management Document Control Systems, Procedures, Forms and Templates 2
K Establishing Item Codes for Production Raw Materials Misc. Quality Assurance and Business Systems Related Topics 2
O Establishing the current value of KPI's (Key Performance Indicators) Manufacturing and Related Processes 1
Y Establishing and Measuring Individual Performance to Product Quality Standards Misc. Quality Assurance and Business Systems Related Topics 5
C Establishing alert and action limits for clean room bioburden Other Medical Device and Orthopedic Related Topics 9
E Establishing a biocompability test lab for testing EN 10993 series EU Medical Device Regulations 1
P Establishing Thickness Specifications from Measured Data Capability, Accuracy and Stability - Processes, Machines, etc. 11
A Initial condition for establishing significant environmental aspects Miscellaneous Environmental Standards and EMS Related Discussions 1
S Establishing Control of Regulations that concern my company Quality Manager and Management Related Issues 12
D Establishing New Training Procedure - Past Training of Existing Employees Training - Internal, External, Online and Distance Learning 6
J Establishing Proposal Metrics in a Factory Construction Company Quality Tools, Improvement and Analysis 6
A How to do Equipment Validation - Establishing our ISO 13485 QMS procedures Qualification and Validation (including 21 CFR Part 11) 34
B True Position without tertiary datum? Establishing a proper rotation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
Coury Ferguson Interpretation of IAF Guide 62 - Establishing the Competence of the Auditors Registrars and Notified Bodies 11
S Establishing Internal Audit Nonconformity Level Criteria - Major vs. Minor? Internal Auditing 46
H Establishing Employee Competencies and Training - Future Training Plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P China - Establishing Quality Systems for Chinese Suppliers Supplier Quality Assurance and other Supplier Issues 8
Q Feedback System (8.2.1) - Requirements for "..establishing a documented procedure..." ISO 13485:2016 - Medical Device Quality Management Systems 5
Douglas E. Purdy Transition to ISO 9001:2000 - RFI - 009, RFI-003, & Establishing a QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9

Similar threads

Top Bottom