Establishing a Data Analysis Procedure

Elsmar Forum Sponsor

badidi

Starting to get Involved
#3
we produce a ball valve and we intend to get API 6D mongaramme. actually i work to etablish procedures for API Q1 and analyse of data is one of theme,
 

Steve Prevette

Deming Disciple
Leader
Super Moderator
#4
API Q1 is a copyrighted document that one must pay for, so I do not have a copy myself. I see it references ISO 9000 which certainly allows the use of statistical process control for data analysis and does have random sampling requirements. I did do some work for Schlumberger for their HSE department and they shifted to SPC and published a paper at a SPE conference some years back.

There is also this discussion on the COVE - How to correctly understand the bullet list d) of 6.3 Analysis of Data for API Spec Q1 (elsmar.com)

In that discussion I did also reference SPC and the Hanford Trending Primer that is here on the COVE. I am not saying it is the ONLY way to meet the requirements, but I am confident they would be acceptable to meet the requirement.
 

Steve Prevette

Deming Disciple
Leader
Super Moderator
#5
Repeating from the Conformity Matrix that I found for the past discussion:

"The organization shall establish processes to ensure that:a) importance of meeting customer, legal, and other applicable requirements is communicated at relevant functions within the organization; andb) results of analysis of data (see 6.3) are communicated at relevant levels and functions within the organization."

"The organization shall maintain a documented procedure for the identification, collection, and analysis of data to demonstrate the suitability and effectiveness of the quality management system. The analysis shall include data generated from monitoring and measurement, internal audits (see 6.2.2), management reviews (see 6.5), and other relevant sources. The data analysis output shall provide information relating to: a) customer satisfaction (see 6.2.1); b) conformity to product requirements; c) nonconformities and product failures identified after delivery or use, provided the product or documented evidence is available to facilitate the determination of the cause (see 5.10);d) characteristics and trends of processes and products including opportunities for preventive action (see 6.4.3); e) supplier performance (see 5.6); and f) quality objectives (see 4.1.3).The organization shall use data to evaluate where continual improvement of the effectiveness of the quality management system can be made."

Most of this is knowing what to measure that is specific to your product (you mentioned ball valves - I am fairly familiar with those from nuclear submarines). The verbiage above is relatively generic to ISO 9000, and NQA-1 and the "QA Rule" (10 CFR 830.122) which I had to work to in the nuclear industry.
 
Last edited:

malasuerte

Involved In Discussions
#7
hi everyone, i want to know the step to follow to establish a data analyse procedure
Hi Badidi, good info above, but an easy way to start is by simply asking What, Why, When, Where, How, Who.
  • Why do I need to do data analysis?
  • What do I need to measure in order to get the data for the data analysis?
    • Why do I need this data?
  • How will I measure and get that data?
  • Who (or what) will measure and get/provide the data?
  • When do I get this data? (How often)
  • When do I communicate the data analysis?
  • Who do I communicate the data analysis to?
etc. etc. etc.
 
Thread starter Similar threads Forum Replies Date
P Establishing Thickness Specifications from Measured Data Capability, Accuracy and Stability - Processes, Machines, etc. 11
qualprod Criteria % to be useful in establishing Kpis ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
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
D Establishing and controlling process capability - Meaning of Phrases Capability, Accuracy and Stability - Processes, Machines, etc. 2
armani 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

Similar threads

Top Bottom