Trend Review and Process Improvement help needed

S

silentrunning

#1
We have several newer machines that have optical gaging and are self-adjusting while they run. We set the control limits and the machine does the rest. Any parts that fall outside the control limits are rejected by the machine as it runs. It also adjusts the machine to bring the dimension back toward the mean. Scrap from these machines is approximately 0.05%. Recently we were audited by one of our large customers and they noticed the machines running. They also noticed the SPC data being displayed on the monitor. When we received the Audit Report one of the recommendations was:
“ Establish and review SPC trend: (Our company) has acquired tools / machines with internal SPC capability. It has not been used for historical trend review or process improvement. (Customer name) recommends establishing history trend to use as process review and improvement”.
I don’t even know where to start to use the SPC data since the machine self corrects and the vast majority of jobs have zero rejects. I could sure use some guidance on this one.


Doug
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
We have several newer machines that have optical gaging and are self-adjusting while they run. We set the control limits and the machine does the rest. Any parts that fall outside the control limits are rejected by the machine as it runs. It also adjusts the machine to bring the dimension back toward the mean. Scrap from these machines is approximately 0.05%. Recently we were audited by one of our large customers and they noticed the machines running. They also noticed the SPC data being displayed on the monitor. When we received the Audit Report one of the recommendations was:
“ Establish and review SPC trend: (Our company) has acquired tools / machines with internal SPC capability. It has not been used for historical trend review or process improvement. (Customer name) recommends establishing history trend to use as process review and improvement”.
I don’t even know where to start to use the SPC data since the machine self corrects and the vast majority of jobs have zero rejects. I could sure use some guidance on this one.


Doug
Any suggestions for Doug?

Thank you!!

Stijloor.
 
T

The Specialist

#3
Silentrunning...

Sorry, are you saying that the machine does, or does not store historical data?
 
T

The Specialist

#4
Silentrunning...

The reason I asked the above question is that if your equipment/machines store the SPC data, it will be a very simple excersise to review/trend and report.
"Improvement" may not be possible, but continued assurance can be given based upon trend data taken direct from the equipment. A short review of the data and report excersise would then be ample.
 
T

The Specialist

#6
They do have all the data available for download at any time.
Then you are well over half-way there!

You can provide a graphical (line-graph) representation of all the critical parameters (monitored in real-time) as shown on the print-out from the equipment.

A review of this data will conclude that all monitored critical parameter readings fall within the upper and lower tollerences of your process specification...

Or something along those lines.
 
T

The Specialist

#7
Further to the above,

Demonstrate the accuracy of the monitoring devices upon which the internal SPC controllers operate through testing (validation, verification, calibration, other (as appropriate).

Also...

'Historical data cannot be manipulated'...

'operational set-points and alarm control'

Etc... (to provide evidence of robustness)
 
Thread starter Similar threads Forum Replies Date
T Trend Reporting under the EU MDR EU Medical Device Regulations 11
Ed Panek Requirement to track and trend positive feedback from customers ISO 13485:2016 - Medical Device Quality Management Systems 12
QMMike New Trend of not seeking Official ISO 9001 Registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
S Track Cpk trend Statistical Analysis Tools, Techniques and SPC 5
J TS 16949 - The Rules performance trend for 12 months IATF 16949 - Automotive Quality Systems Standard 7
D Best Minitab Tool to determine a Statistically Significant Trend Using Minitab Software 5
D Vigilance Trend reporting requirements of Meddev 2.12/ver 7 in the EU Document Control Systems, Procedures, Forms and Templates 1
L GB15980-2003 Bioburden Count Trend on Operator Hands Other ISO and International Standards and European Regulations 1
R Out of Trend (OOT) investigation Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
A Aircraft Maintenance Quality & Safety KPIs - Industry Trend or Database EASA and JAA Aviation Standards and Requirements 3
A Aircraft Maintenance Quality & Safety KPIs - Industry Trend or Database Quality Manager and Management Related Issues 4
K Customer Satisfaction - Would you advise to investigate the trend or the incidence? Customer Complaints 9
C Trend Analysis - Evaluating Quality of Pricing - ANVOA or Std Dev? Statistical Analysis Tools, Techniques and SPC 25
Marc Definition Significant Trend Trigger Level - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
R Trend Chart Clarification - Is it necessary to include targets? Misc. Quality Assurance and Business Systems Related Topics 2
Marc Enraged Customers fuel a disturbing trend Customer and Company Specific Requirements 9
F Trend Analysis of Kanban System for our Finished Goods Statistical Analysis Tools, Techniques and SPC 6
K Supplier Performance - Recording Supplier Performance for long term trend reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Crusader Registrar CAR (Corrective Action Request) Trend Analysis Benchmarking 6
T Control Chart on Paper vs. Software where trend cannot be seen (Alarm only) Statistical Analysis Tools, Techniques and SPC 8
B Statistical Analysis SPC Trend explanation needed Statistical Analysis Tools, Techniques and SPC 4
P Trend analysis - Common Mistakes of Sales Process Mapping Software Quality Assurance 2
S How to Calculate Out-of-Trend Results Statistical Analysis Tools, Techniques and SPC 16
Q Root Cause Analize or Trend Project Audit Findings Problem Solving, Root Cause Fault and Failure Analysis 2
D How do we interpret the following XmR Trend Chart data? Statistical Analysis Tools, Techniques and SPC 3
D When to use an XmR Trend Chart Statistical Analysis Tools, Techniques and SPC 5
ScottK Is using a 3rd party auditor for supplier audits a big trend? Supplier Quality Assurance and other Supplier Issues 14
Crusader Customer Concerns Trend Database to Share .xls Excel file Customer Complaints 17
D Is there a process shift and/or trend in the attached control chart? Statistical Analysis Tools, Techniques and SPC 33
M Toyota Approach to Root Cause Analysis - Operator Error trend Problem Solving, Root Cause Fault and Failure Analysis 9
Marc Bye-Bye, Pension! The trend in the US to reduce middle class worker wages World News 17
G Control charts where the center line is a trend or slope? Statistical Analysis Tools, Techniques and SPC 26
C The Life Cycle of a Trend The Reading Room 3
L Effective Meetings for trend analysis - Corrective and preventive action Nonconformance and Corrective Action 8
Q Pole Data Trend Analysis Help - Monitoring the % of poles that we have to straighten Quality Tools, Improvement and Analysis 34
W TREND Identification - Good (and simple) procedure or process to identify and track Other ISO and International Standards and European Regulations 4
Steve Prevette Life Cycle of a Trend - An SPC Overview Registered Visitor Articles Archive 7
B Searching for software to track and trend customer complaints Customer Complaints 11
D Control charts to trend data for multiple dependent variables? Hotelling's T^2 stat Statistical Analysis Tools, Techniques and SPC 3
Y Control Chart Rules - Trend and Statistics Explainations Statistical Analysis Tools, Techniques and SPC 13
A Internal Audit - Negative Trend Identified - What Clause to Cite? Internal Auditing 3
A Positive Trend - Rejections and Customer Complaints - What to do? Customer Complaints 6
A Document Review and Document Approval --- 2 Signatures needed acc. §820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Y Procedures on Contract Review Document Control Systems, Procedures, Forms and Templates 3
J Example of a defined procedure for carrying out Material Review Board (MRB) Manufacturing and Related Processes 0
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 4
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
S Risk Management Review ISO 14971 - Medical Device Risk Management 4
G Management Review (integrated system) Management Review Meetings and related Processes 17
M Management review check-list Management Review Meetings and related Processes 3

Similar threads

Top Bottom