Analysis of Data - The former "Statistical Techniques" procedure

R

Roger Eastin

#1
#1
Just a quick question: For this part of the standard, did you modify (including the usual suitability, effectiveness and continual improvement statements)the former "Statistical Techniques" procedure to include the four topics (a-d) listed in the standard?
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
D

David Mullins

#2
#2
Quick Answer: No.

Reason: A lot of the stuff in 8.1, 8.2.3, 8.2.4 & 8.4 I had covered under corrective/preventive action and management review.

8.1 is just another sumarry set of the other para's.

The new standard helps enforce the "quality can be meaningful" aspects of process and product critical characteristics and and performance monitoring and review, with customer satisfaction thrown in as something that just might be important in determining success of outcomes.

------------------
 
R

Roger Eastin

#3
#3
David - thanks for the input. You're right as I had those topics covered under other procedures as well. However, I was wondering when you are writing your new (updated to ISO9001::2000) procedure did you include these items under your old statistical techniques procedure or did you continue to leave them scattered in other procedures (so thus, you didn't change anything)? I want to modify as little as possible for the upgrade.
 
D

David Mullins

#4
#4
Left them spread.
Below is an excerpt from the Business Systems Manual's ISO 9001 DOCUMENTATION MATRIX (unfortunately tables don't come out well here, basically the VPs are system level procedures - L2s). So 8.4 is covered via 9 procedures. I suppose you could use the vernacular of ISO 9000:2000 and say the procedures are process orientated not ISO orientated.


8.1 Measurement, Analysis And Improvement - General VP1001-1005; VP3001-3005
8.2.1 Customer Satisfaction VP1005
8.2.2 Internal Audit VP1004
8.2.3 Monitoring And Measurement Of Processes VP1002; VP1004; VP3006
8.2.4 Monitoring And Measurement Of Product VP3001; VP3004-3006
8.3 Control Of Nonconforming Product VP1006
8.4 Analysis Of Data VP1002-1005; VP3002-3004; VP3006; VP7001


------------------
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Data analysis Design of Experiments Using Minitab Software 3
S Minitab - Factor Analysis: Label on second series of data for Biplot Using Minitab Software 4
J ISO 13485 8.4 Analysis of Data - Procedure example ISO 13485:2016 - Medical Device Quality Management Systems 1
T Difference between "data analysis" and "management review" ISO 13485:2016 - Medical Device Quality Management Systems 4
T Likert Analysis of Data from a Survey Statistical Analysis Tools, Techniques and SPC 6
E Risk Analysis - Events which may cause to Data Loss ISO 14971 - Medical Device Risk Management 12
P Minitab Data Analysis - Understanding if a Process is in Control or Not Using Minitab Software 2
M Treatment system data analysis - Subject to CFR part 11? Entire system? Qualification and Validation (including 21 CFR Part 11) 7
N Tool frequency change - Data Analysis needed Statistical Analysis Tools, Techniques and SPC 9
R Need Help on Analysis: How to know potential causality model from historical data Problem Solving, Root Cause Fault and Failure Analysis 5
R Variables Data Type Analysis help Quality Tools, Improvement and Analysis 4
M PCDMIS-Excel Data to Minitab for Analysis Using Minitab Software 2
F MSA - Measurement System Analysis Attribute Data Crosstab sheet APQP and PPAP 1
A Recording Data and Data Analysis 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Y Statistical Analysis of Road Traffic Data Statistical Analysis Tools, Techniques and SPC 11
M PhD Thesis Data Statistical Analysis Methods Statistical Analysis Tools, Techniques and SPC 2
R MCF analysis with Left & Right Censored (Truncated) Data Reliability Analysis - Predictions, Testing and Standards 1
R Sample vs. Population (Data Analysis) Statistical Analysis Tools, Techniques and SPC 11
A Repairable System Reliability Analysis: Uptime/Downtime Hours, Failure Modes Data Reliability Analysis - Predictions, Testing and Standards 2
N Critical Analysis of Medical Device Bench Testing data ISO 13485:2016 - Medical Device Quality Management Systems 6
V MSA Attribute Data Analysis Study IATF 16949 - Automotive Quality Systems Standard 1
S Data for Analysis - Construction Industry Table of Data for Analysis ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
W What kind of data is expected for a PPAP Material Analysis Report IATF 16949 - Automotive Quality Systems Standard 7
optomist1 Data Analysis - Transform Data or Not Capability, Accuracy and Stability - Processes, Machines, etc. 9
R Capability Analysis (using Histogram) for Subgrouped Data Statistical Analysis Tools, Techniques and SPC 16
F Dealing with, and Analysis of, Data Statistical Analysis Tools, Techniques and SPC 6
T SPSS for Analysis of Medical Data - Need help Statistical Analysis Tools, Techniques and SPC 12
H Minitab DOE Analysis of Data and Transforming Using Minitab Software 4
Q What data analysis software do you use? Quality Assurance and Compliance Software Tools and Solutions 4
M Analysis and Use of Data clarification - TS 16949 Clause 8.4.1 IATF 16949 - Automotive Quality Systems Standard 4
K Non-Normal Data Analysis Literature, Websites, Books for Learning Quality Tools, Improvement and Analysis 2
G The Documentation of Data Analysis for an ISO 13485 Medical Device Submission ISO 13485:2016 - Medical Device Quality Management Systems 9
C Process Capability - Attribute Data Analysis (Template) Document Control Systems, Procedures, Forms and Templates 0
C Process Capability - Variables Data Analysis (Template) Document Control Systems, Procedures, Forms and Templates 0
Q Regression Analysis for the Attached Data - help needed - TIA Reliability Analysis - Predictions, Testing and Standards 13
F SPC Data Analysis - Excel Spreadsheet I can use for Diameters and Perpendicularity Capability, Accuracy and Stability - Processes, Machines, etc. 6
J Applicable Statistical Analysis Method for this Data Six Sigma 17
C Who does the Analysis of Nonconformances and other Data Analysis? Nonconformance and Corrective Action 23
Y Analysis of Data Procedure: Requirements for OBL (ISO 13485) ISO 13485:2016 - Medical Device Quality Management Systems 2
P Data Analysis - Johnson Transformation/Weibull Distribution/Capability Analysis Capability, Accuracy and Stability - Processes, Machines, etc. 10
A Best Way for SPC via Optical Comparator with output to Computer for Data Analysis Statistical Analysis Tools, Techniques and SPC 4
V Help on C Sat Data Analysis - Should I use discriminant analysis? Six Sigma 8
K Data Analysis of Milk Composition (Seven Parameters like Protein, Fat, Lactose, etc.) Using Minitab Software 18
7 Data Analysis of Tensile Strength Test - Graphical Presentation of Results Statistical Analysis Tools, Techniques and SPC 2
T Analysis of Sample Data Sets - Incidence of Canine Rabies Statistical Analysis Tools, Techniques and SPC 2
K GR&R (Gage R&R) Analysis for Negative Measurement Data Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
B FDA QSR Data Analysis & Trending Requirements US Food and Drug Administration (FDA) 5
Hami812 Normality of Data Question - Minitab Analysis Statistical Analysis Tools, Techniques and SPC 12
Statistical Steven Continuous Data Analysis Sample Size Determination Six Sigma 3
somashekar Too much data, Too little analysis - Manual Stages Assembly Shop Data Collection Quality Tools, Improvement and Analysis 2
Similar threads
Top Bottom