Locking Control Limits and SPC Sample Sizes (AIAG/Automotive Requirements)

dave.d

Starting to get Involved
Does anyone know of automotive OEM requirements on when to lock control limits and/or requirements of the number of samples required prior to calculating control limits?

We have been discussing the phenomenon of a stable process with control limits narrowing to the point of a nonconformance occurring due to a point being out of control. I've seen reference to "locking" control limits and am wondering if anyone is familiar with either IATF/AIAG or automotive OEM requirements on how/when this is done.

Thank you,

Dave
 

Steve Prevette

Deming Disciple
Leader
Super Moderator
I would definitely NOT recommend "locking" the control limits. They would then simply become specification limits and would not be based upon the current data. If the variation has been reducing with time due to improvements (yea!) you should follow the data and narrow the control limits if you understand what the change was that cause the variation to reduce. That is an important point Dr. Wheeler pushes - you do want to be sure you know WHY the process changed before you change the control limits. In my experience, even if you do not know, you eventually need to "follow the data".

If a process has been improving, with improved data and control limits in your SPC trending, you would still want to examine why you got an out of control (but perhaps in specification) result. Graded approach is acceptable - but the idea still is to head off a problem BEFORE you end up making out of specification components.
 

HVogt

Registered
If you do not lock the control limits you run the risk of missing important signals. If you have a process that is slowly trending in one direction and you do not have your limits locked, the limits will continue to shift with the process and you will have what would have been out of control points that will not be tagged as out of control. Same thing if you have a process where the variation is gradually growing. It's like the old story about the frog not realizing it's boiling in the pot of water that slowly heats up. I've run into this problem using a certain MRP program with a built in control chart feature that keeps recalculating the control limits.
 
Thread starter Similar threads Forum Replies Date
I Locking worksheets ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V Supplier wants to perform pre-qualifications prior to every run instead of locking in parameters. Supplier Quality Assurance and other Supplier Issues 7
V Locking in a Standards Version (ANSI Z1.4) Statistical Analysis Tools, Techniques and SPC 1
D Military Specifications for Fasteners - Silver-Plated Self-Locking Nut - MS20500 Manufacturing and Related Processes 6
Marc Locking Yourself Into Windows? After Work and Weekend Discussion Topics 1
I Integrating CAPA and Change Control processes ISO 13485:2016 - Medical Device Quality Management Systems 3
A Can a Form Template be altered in a 13485 document control system? ISO 13485:2016 - Medical Device Quality Management Systems 4
R ILAC G24 - defining process control measures, ISO 17025 related Discussions 2
MaHoDie How deep should be risk control tracebility IEC 62304 - Medical Device Software Life Cycle Processes 3
S Control of Drawings in Production Environment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
T OTS (Off-the -Shelf) Software involved in error control and messaging US Food and Drug Administration (FDA) 1
D Control Limit Calculation with multi-cavities molding Statistical Analysis Tools, Techniques and SPC 5
G Clause 8.5.1 -- Is non Identification evidence of ineffective control of production ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
J Document Control Requirements within Oracle System Document Control Systems, Procedures, Forms and Templates 1
Q IATF / AIAG: Control Plans and CC / SC requirements FMEA and Control Plans 4
Ashland78 IATF Process Control Plans not including customer name Manufacturing and Related Processes 13
M What should be measurement method in control plan if you are defining Control method as work instruction. Manufacturing and Related Processes 5
G Help Needed: Quality Control / Assurance process Quality Manager and Management Related Issues 3
T Document Approver System AS9100 Doc Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
T Terms & Conditions Document Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
G Control of Externally Provided Processes, Products, and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
Crimpshrine13 Bulk Process (Electroplating), Control Plan, and Process Change IATF 16949 - Automotive Quality Systems Standard 1
giavannatabbs ISO 9001:2015 Control of Records - QMS Communications? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Introducing a document control system benefits Document Control Systems, Procedures, Forms and Templates 13
N Effective use of a Risk Register - Bumper sticker or Mission Control ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
L To control the essential design outputs Medical Device and FDA Regulations and Standards News 4
G Root cause for outsourced pest control service not in approved supplier list ISO 13485:2016 - Medical Device Quality Management Systems 4
A Digital Document Control - Revision ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
O Process Flow Diagram, DFMEA, PFMEA, Control Plan integrated softwares FMEA and Control Plans 7
V Over 60 dimensions CMM measurement in control plan APQP and PPAP 8
A Document control system for QMS in Google Drive? Document Control Systems, Procedures, Forms and Templates 6
V Opinion on gauge control graphic General Measurement Device and Calibration Topics 5
S ISO 14001 Operational Planning and Control - Proving evidence of communicating environmental requirements to suppliers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V How to control odour outside paintshop ISO 14001:2015 Specific Discussions 1
G FMEA versus control plan IATF 16949 - Automotive Quality Systems Standard 6
K ISO 2859-5 (single run production) control plan issues FMEA and Control Plans 2
E Control Charts ISO 17025 related Discussions 7
E Control of Sterile Barriers made by the supplier Design and Development of Products and Processes 4
E Do anyone have document of automotive production risk and control of risk? Lean in Manufacturing and Service Industries 1
M X-MR Control Chart Rules (Particularly the MR) Statistical Analysis Tools, Techniques and SPC 3
I Clinical study suppliers (service providers) -- extent of control ISO 13485:2016 - Medical Device Quality Management Systems 4
P Product Requirements Control during Design Changes Design and Development of Products and Processes 4
T Control Excel template Document Control Systems, Procedures, Forms and Templates 5
J Document Control of Online Management Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
R 8.7 Control of Nonconforming Outputs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
W Document control Document Control Systems, Procedures, Forms and Templates 10
S Control plan - Multiple batches Manufacturing and Related Processes 2
Q Control Plan and the frequency of sampling FMEA and Control Plans 11
A ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
qualprod Sheets into a spreadsheet document control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4

Similar threads

Top Bottom