Statistics - Where to start in ISO 9001?

qualprod

Trusted Information Resource
#1
Hello everybody
I come looking for guide regarding statistical analysis.
Into an ISO 9001 system, I´ve been gathering a lot of data of production, in order to be analyzed to implement improvements.
I have a spreadsheet, with headings like: work orders, date, quantity produced, defective product, operator, machine, time spent in production, days spent in each work order, used raw material (description and quantity) and so on.
My background is not specialized in statistics, I know very little, but I want to start to analyze the data.
I can start to use pareto, histograms, average values, which I already know , but no more.
Could you guide me, where to start , what to do, what to read in order to make very good analysis of such information and
that finally can get sufficient info to be translated to improvement projects?
I know that into statistics , there are a lot of unknown terms for me, but probably are not applied for my purpose.
e.g. Binomial distribution, Box plot, Central limit theorem, Continuous distribution, Geometric distribution, Interquartile range, Pascal distribution
I don´t want to make sophisticated analysis, only those which could help me to improve the production processes.
The idea it is to use the less methodologies but that really can be applied to my business.
Thanks for your inputs.
 
Elsmar Forum Sponsor

Bill Levinson

Industrial Statistician and Trainer
#2
ISO 9001 doesn't really have statistics requirements although IATF 16949 requires activities like measurement systems analysis (ISO 9001 does not). The thing to do in ISO 9001 is to use whatever methods are appropriate to fulfillment of your quality management system's mission. "Defective product" could, for example, be subject to control charts for defects or nonconformances.

On the other hand, some of the tools you mention such as Pareto charts are applicable to root cause analysis, and therefore corrective and preventive action (CAPA) which is required by the standard. The Pareto chart is applicable, though, only if you are trying to prioritize among several different problems. If you have different defect sources, the Pareto chart would be applicable.
 

Big Jim

Trusted Information Resource
#3
All of that can be very insightful when needed but a huge waste of time when not needed.

I believe in the philosophy of management by exception. Spend you time on the abnormalities that pop up, not on the good stuff. Even with that philosophy, it is helpful to have a basic set and the basic set I use are 1) a measure of customer satisfaction, 2) a measure of product quality, 3) on-time delivery, and 4) a measure of supplier performance.

When an abnormality pops up, no matter how it is found, dig deeper with whatever method of investigation is appropriate, including any of the ones you mentioned. Otherwise it is paralysis of analysis.
 

Tagin

Trusted Information Resource
#4
Could you guide me, where to start , what to do, what to read in order to make very good analysis of such information and that finally can get sufficient info to be translated to improvement projects?
Looking at it in this direction (data analysis -> improvement) is kind of a random data mining/sifting activity, where you are hoping the analyzed data will somehow show a pattern that you can somehow detect and then act upon.

It would be much simpler, and probably a lot more effective, to go in the other direction (improvement need -> data analysis). This will more clearly define the kind of analysis and statistical approaches needed for a specific goal.

The other problem with the first approach is that it can only show you patterns on data you have collected. There may be needs for improvement that require data you have not collected, or have measured differently than needed, and so those patterns would then be undetectable from your data.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#5
I echo what the others have said. Statistical methods are not to be used randomly. The best approach for you is to determine what is important to your organization FIRST. Meeting build plans? Capacity/productivity? Yields or defect rates? Then you really only need Paretos and run Charts. What are the biggest problems? (This may be quantified in terms of occurrences or cost or cycle time consumption). Trend the data fro each item in the Pareto - is it getting better, worse or is it stable? THEN pick an area to improve. You will need to go collect specific data on that problem - the answers won’t be in the general data you have in your spreadsheet.
 

normzone

Trusted Information Resource
#6
What [Bev D] said.

A simple track-and-trend the percentage of success (meeting schedule for process dwell time or delivery, or passing quality inspection or test) yields valuable data. If those numbers are acceptable, then you can get fussier and slice your data finer. If they're not, look into why not.
 
Thread starter Similar threads Forum Replies Date
P Where to find conformance statistics for ISO 15189 Other Medical Device Regulations World-Wide 1
B Descriptive Statistics where the Data Type is Text? Using Minitab Software 4
Richard Regalado What could go wrong with information: Ransomware statistics and facts (2018 to present) IEC 27001 - Information Security Management Systems (ISMS) 0
I Good resources for learning statistics (quality engineering related) Statistical Analysis Tools, Techniques and SPC 10
Ninja Visitor Statistics - How to see a poster's stats easily? Elsmar Xenforo Forum Software Instructions and Help 3
D How do you use statistics in your job Statistical Analysis Tools, Techniques and SPC 6
J Excellent Resource on Statistics / Lean / Six Sigma Book, Video, Blog and Web Site Reviews and Recommendations 2
V Accelerated Learning and Simulations / Scenarios - Statistics Statistical Analysis Tools, Techniques and SPC 0
V Statistics - Designs - Differences between Orthogonality and Confounding Using Minitab Software 5
M Statistics Question - What percent falls above 105? Statistical Analysis Tools, Techniques and SPC 2
A Assessing a Preventive Maintenance Strategy - Reliability or Maintenance Statistics Reliability Analysis - Predictions, Testing and Standards 2
S Statistics and Sampling - Accounting for Failed Tests Statistical Analysis Tools, Techniques and SPC 10
T Metrics and Statistics for Improvement - Easy to implement Statistical Analysis Tools, Techniques and SPC 4
C Statistics equation to determine the number of samples in a lot Statistical Analysis Tools, Techniques and SPC 8
A ASQ CQE statistics training in Australia? Training - Internal, External, Online and Distance Learning 2
E Online Degrees and Graduate Certificates in Statistics Training - Internal, External, Online and Distance Learning 1
AnaMariaVR2 Guide to Microsoft Excel for Calculations, Statistics, and Plotting Data Excel .xls Spreadsheet Templates and Tools 11
C Basic Statistics Template .xls Document Control Systems, Procedures, Forms and Templates 0
S Statistics in Check/Replicate Analysis - HPLC Assay (Sample Duplicates) Statistical Analysis Tools, Techniques and SPC 1
R Student Question - Help needed with statistics questions Statistical Analysis Tools, Techniques and SPC 6
M The Statistical Meaning of "Muddy Middle" - Statistics Terminology Statistical Analysis Tools, Techniques and SPC 6
R Industry Statistics on the benefits of Quality Management Systems ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Jim Wynne xkcd on Statistics and Mainstream Media Funny Stuff - Jokes and Humour 2
A R using RExcel - Non GUI Statistics Program Statistical Analysis Tools, Techniques and SPC 1
Wes Bucey Job recovery? or "statistics don't lie, people do" Career and Occupation Discussions 37
G Statistics Question from Production and Operations Management Course Statistical Analysis Tools, Techniques and SPC 3
O Information on the extent of Statistics in the Six Sigma Green Belt Exam Professional Certifications and Degrees 9
J Gage R&R Module for R (Statistics Program) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
T Survey or Statistics on the use of OHSAS 18001 Worldwide Occupational Health & Safety Management Standards 66
T Survey or Statistics on the use of the AS 9100 Standard Worldwide AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
H Elsmar Cove Statistics Found Online Coffee Break and Water Cooler Discussions 2
Chennaiite Quotable Quotes - Statistics Funny Stuff - Jokes and Humour 10
S Statistics of Gage R&R & Boundary Specifications Statistical Analysis Tools, Techniques and SPC 15
K Sample Statistics on HR (Human Resources) Key Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
bio_subbu FDA released guidance on use of Bayesian statistics in Clinical Studies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
O Weighting Problems (Statistics) - Weight distribution for a machine setup Capability, Accuracy and Stability - Processes, Machines, etc. 5
S "Human Error" statistics Quality Manager and Management Related Issues 3
S ASQ CSSBB Exam & Knowledge of Statistics Professional Certifications and Degrees 3
J Are there PPM statistics kept by Industry Manufacturing and Related Processes 4
Marc Battery-Life Statistics After Work and Weekend Discussion Topics 4
F Error in Minitab (no statistics can be calculated with these data) Using Minitab Software 10
O The Basis of %GRR (% Gage R&R) and other Statistics - Minitab Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 21
V Management Review Meeting - Statistics for Customer Complaints and Non Conformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T The use of Statistics at a Medical Device Manufacturer US Food and Drug Administration (FDA) 16
Y Statistics and MiniTab - Example Problems Using Minitab Software 4
W Application of Statistics/ SPC tools in Oil Refineries Statistical Analysis Tools, Techniques and SPC 11
Q Specific requirements for Statistics in CQE exam Professional Certifications and Degrees 3
A Best certification combination with Masters in Statistics Professional Certifications and Degrees 2
BradM Use of Non-Parametric Statistics and Non-Normal Data Statistical Analysis Tools, Techniques and SPC 33
A Statistics Sampling Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
Similar threads


















































Top Bottom