Internal Results vs. Independent Testing Laboratory - Inkometer

Southern Cross

Involved In Discussions
#11
The varnish is at viscosity 150 Pa.s, which translates to 1500 Poise, much too high in viscosity to use something disposable. A 1.32 ml stainless steel pipette comes with the instrument.

In the interim, I've been doing some evaluations of the machine, firstly using the calibration weights. See the first image for the Bias and Linearity check. The instrument reads lower as the tack increases. This isn't of major concern, but there is significant variability in the readings. The second image is the result of 30 day by day checks of the instrument using the 25 unit calibration weight. This is close to the area where we do our testing.

Third and fourth images are from a very short designed experiment that I ran using different temperatures and sample weights. The effect of changing sample weight is obvious.

I suspect that the operators are using the pipette in such a way that air bubbles are present in the sample, reducing the weight of varnish applied. We could talk to them about taking greater care with filling the pipette, but I suspect it may be better to just stipulate that a certain weight be used, even if the density of the sample may change from batch to batch. It's likely that we'll change the test method in just this way.

After that, it would be my intention to push for a Gage test, including all of the operators of the instrument. That way we can potentially see if anyone needs some more training. Any thoughts?
 

Attachments

Elsmar Forum Sponsor
S

stenna10

#12
Hi,
Common method for dealing with this capability mismatch is to reduce the accuracy of the device being calibrated. For example, a gage with 3% manufacturer-stated accuracy can be changed to 4% so that a 1% accuracy standard can be used at 4:1. If the gage is used in an application requiring 16% accuracy, having the gage accuracy reduced to 4% will not affect the accuracy of the final measurements. This is called a limited calibration. But if the final measurement requires 10% accuracy, then the 3% gage never can be better than 3.3:1.
 
Thread starter Similar threads Forum Replies Date
lanley liao How to understand this words that the planning of internal audit shall take into consideration the results of previous audits? Oil and Gas Industry Standards and Regulations 10
C How should I present Internal Audit results to Management in Management Review Internal Auditing 18
Casana The right way to Report Internal Audit Results Internal Auditing 20
C Reporting Profile of a Surface Results on an Internal Cylindrical Feature Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
O Should Staff have Access to see Internal and/or CB Audit Results? Internal Auditing 5
L Internal Audit Recommendations - CAPA from audit results Nonconformance and Corrective Action 7
Q Evaluating Internal Audit Results Internal Auditing 24
F Software Program for tracking internal audit results needed Quality Assurance and Compliance Software Tools and Solutions 2
J Process Audit Checklist to document Internal Process Audit results Process Audits and Layered Process Audits 19
K Are internal audit results a true reflection of the organisations quality system Internal Auditing 2
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
M ISO13485:2016, MDSAP and Internal Audits ISO 13485:2016 - Medical Device Quality Management Systems 8
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 7
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Would this be a second site for the purposes of internal and third party audits? General Auditing Discussions 4
V Internal Auditor Competency KPI IATF 16949 - Automotive Quality Systems Standard 14
J ISMS - Internal Audits Internal Auditing 3
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
S ISO 9001:2015 Internal Auditing Internal Auditing 8
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
L Documented Information in Internal Audits Process (9.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
salaheddine96 Internal audit planning Internal Auditing 2
D CB and customer audits considered as internal audits? General Auditing Discussions 9
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
E MDR internal audit Internal Auditing 1
B Internal Auditor Competency - Product Auditors Internal Auditing 9
U Internal Auditor not trained but done Audit for some process Nonconformance and Corrective Action 5
F Internal transfer of work from one line to another? Qualification and Validation (including 21 CFR Part 11) 3
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
R Monitor production quality - Internal KPIs Manufacturing and Related Processes 5
R IATF 16949 - Outsourcing of internal audits Internal Auditing 10
M Major vs. Minor for Internal Audits? Internal Auditing 10
T Internal Nonconformance procedure thoughts (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Tips on preparing for IATF 16949 Internal Lead Auditor exam Manufacturing and Related Processes 1
C Internal Audits in a tiny Dx Company Internal Auditing 33
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
F Internal Audit before Pre-Assessment ISO 17025 related Discussions 2
Q Internal audit plan template Internal Auditing 12
E PEMS Hazards - IEC 60601 Clause 14.6 - Internal data use - Pressure sensor IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L Internal audit during COVID-19 restrictions ISO 13485:2016 - Medical Device Quality Management Systems 5
A QMS Overhaul - Reorganizing and Renaming Documents - Internal References Document Control Systems, Procedures, Forms and Templates 24
N Sampling Plan for Internal Audits - ISO 2859 or 3951 - Or Neither? Internal Auditing 6
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
M Help me improve the definition for internal PPM Manufacturing and Related Processes 3
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 17
S Risk based internal auditing Internal Auditing 6

Similar threads

Top Bottom