As-Found FAILED calibration

Vader22

Starting to get Involved
#1
Asking for our Environmental Manager. Does ISO 14001 have a requirement to assess the risk of a failed AS-FOUND calibration result similar to IATF 16949 7.1.5.2.1, The organization shall ensure that calibration/verification activities and records shall include the following details: c) an assessment of risk of the intended use of the product caused by the out-of specification condition?
 
Elsmar Forum Sponsor

mattador78

Quite Involved in Discussions
#2
What is the calibrated instrument measuring and how does it affect your envoromental controls? For example we discharge waste water which has to stay within a certain bandwidth, our meters have to be controled and calibrated with a record stored for our enviromental controls which are then compared and contrasted with the water board and the weekly reports they send us. Our Ph meters therefore have a direct impact on our enviroment system. My paint test meters and gloss meter, thickness gauges etc have no impact on the enviromental audits so they have no reference in the 14001 audits or management system.
 

Vader22

Starting to get Involved
#4
I 100% agree with the common sense, but he received an External ISO 14001 Audit nonconformance for this. I was thinking along the lines that an auditor can't give a finding against common sense, only violating the requirements of the standard. Does ISO 14001 require this?
 

Jim Wynne

Leader
Admin
#5
I 100% agree with the common sense, but he received an External ISO 14001 Audit nonconformance for this. I was thinking along the lines that an auditor can't give a finding against common sense, only violating the requirements of the standard. Does ISO 14001 require this?
You should post the entire text of the auditor's NC statement so we can give you the best advice.
 

Vader22

Starting to get Involved
#6
Standard (as applicable) / Requirement (# and description):
9.1.1 Monitoring, measurement, analysis and evaluation : General. The organization shall ensure that calibrated or verified monitoring and measurement equipment is used and maintained, as appropriate. The organization shall retain appropriate documented information as evidence of the monitoring, measurement, analysis and evaluation results.

Nonconformity Description (basis of Root Cause Analysis and Corrective Action):
Measurement equipment is not always effectively controlled.

Objective Evidence Observed (Basis of Correction):
Calibration records indicated as found failures for several pH meters (MU1000 for 6/23/22 & 2/11/22 &4/18/22, MU1001 for 1/30/22 & 2/11/22 & 4/18/22 & 6/22/22) without evidence of investigation/assessment as to impact on environmental systems.
 

Jim Wynne

Leader
Admin
#7
It appears to be a legitimate NC. You calibrate pH meters, and some were found to be out of calibration, and no record was created (or seen by the auditor) of what was done, if anything, to evaluate the impact of the out-of-calibration devices. While 14001 might not be as explicit as 16949, I don't know why this NC would be questioned. As an aside, kudos to the auditor for providing a textbook NC statement.
 

Vader22

Starting to get Involved
#9
Like I said before, I agree with the common sense of assessing the risk, I just don't see the requirement in the standard. If this is indeed a requirement of ISO 14001, then shouldn't it meet the requirements of being explicit? Stated clearly and in detail, leaving no room for confusion or doubt.
 
#10
Like I said before, I agree with the common sense of assessing the risk, I just don't see the requirement in the standard. If this is indeed a requirement of ISO 14001, then shouldn't it meet the requirements of being explicit? Stated clearly and in detail, leaving no room for confusion or doubt.
The organization shall retain appropriate documented information as evidence of the monitoring, measurement, analysis and evaluation results.
So you don't think that providing a documented trail of actions in this situation is appropriate? Good luck arguing that with the auditor. If you expect that ISO standards will always be unambiguous, you're dreaming.
 
Thread starter Similar threads Forum Replies Date
P No trouble found (NTF) IATF 16949 - Automotive Quality Systems Standard 6
M Test failure Root cause not found Customer Complaints 13
M Vigilance - incident found in an article EU Medical Device Regulations 4
Y We found out we have been using a equipment without validation for past 4 years Quality Manager and Management Related Issues 6
A Non-Conformances Found After 3rd Party Sorting Supplier Quality Assurance and other Supplier Issues 12
S ISO 9001 7.1.5.2 - Actions Taken When Measuring Equipment is Found to be Unfit for Use General Measurement Device and Calibration Topics 13
G Correction fluid found on documents that are reviewed Qualification and Validation (including 21 CFR Part 11) 11
Ed Panek ISOTECH TTI-10 found out of calibration - Calibration house was wrong? General Measurement Device and Calibration Topics 7
supadrai Just found out the hard way that only one registration per manufacturer is allowed in Yemen, regardless of OEM or private label arrangement. Other Medical Device Regulations World-Wide 0
supadrai Informational Japan Minor Change Notification Application Form - Found it? Japan Medical Device Regulations 0
M Can we change the ProCode if a better one is found? Other US Medical Device Regulations 3
GStough Pushback on a Nonconformance Found in a Supplier Audit General Auditing Discussions 22
S Recapture Program for Measurement Devices found Out of Calibration General Measurement Device and Calibration Topics 8
GStough Nonconformance Found Outside the Audit Scope - Supplier Audit General Auditing Discussions 16
T Are internally found Medical Device Software "Bugs" Complaints? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A Defect Rate for asking for an RMA - Company wants an RMA for every defect found Supplier Quality Assurance and other Supplier Issues 10
Stijloor Inmate-Produced Combat Helmets Found Defective Supplier Quality Assurance and other Supplier Issues 4
C Calibration Certificate "As Found" condition - TS16949 Section 7.6.2 General Measurement Device and Calibration Topics 7
T What to do if parameters are found to be Outside of Control Limits Document Control Systems, Procedures, Forms and Templates 5
A Does anybody know in which Standard can this attached Alarm Symbol be found? Other Medical Device Related Standards 3
B Nonconforming Parts found by our Service Department Nonconformance and Corrective Action 3
D As Found Condition - In or out of tolerance? General Measurement Device and Calibration Topics 4
J Customer found Nonconforming Product Metrics ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Internal Audit Cancellation when Nonconformances are Found Quality Manager and Management Related Issues 13
D "As Found" Condition and Calibration Interval Changes Calibration Frequency (Interval) 5
N What Would You Do If You Found Treasure - But it's not yours... Coffee Break and Water Cooler Discussions 17
D What is "As Found" in Calibration of a Measurement Device? General Measurement Device and Calibration Topics 8
R "As Found" Calibration Results for HPLCs General Measurement Device and Calibration Topics 22
Q Auditor found Form with Identical Contents but different Format - is this an NC? Document Control Systems, Procedures, Forms and Templates 28
D What should the QMS Auditor do if a Major Nonconformity is found during an Audit? Internal Auditing 11
C National/International Standard For Calibration "As Found" Readings General Measurement Device and Calibration Topics 4
Marc So, I woke up this morning and found this tree growing... Coffee Break and Water Cooler Discussions 4
Y What if the Root Cause can't be found? Nonconformance and Corrective Action 6
R Information found missing in a Medical Device Record Other US Medical Device Regulations 4
Hami812 Predicting the outcome using high No Trouble Found Rate Statistical Analysis Tools, Techniques and SPC 4
A Help needed for Fighting a specifically identified Organism found during Dose Audit Miscellaneous Environmental Standards and EMS Related Discussions 2
R Suppliers Defects found during Production Process - Supplier Scorecards Quality Tools, Improvement and Analysis 6
B CMM Stylus Calibration - Required to record the As Found condition AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
S Want to buy Pinhole Diaphragm(S) per ASTM E1165-04 - Found it! Various Other Specifications, Standards, and related Requirements 3
Q Torque Wrench Issue - Incorrect method to collect the "as found data" Problem Solving, Root Cause Fault and Failure Analysis 7
S Top 10 areas where most NC's are found during CB audits? General Auditing Discussions 4
S External Auditor Findings when an Internal Audit found a Nonconformance Yesterday Document Control Systems, Procedures, Forms and Templates 11
D Found Watch - Watch is "Element" and says "New York" Coffee Break and Water Cooler Discussions 16
M "As Found" (aka "As Received") Calibration Data - ISO 13485 Requirements ISO 13485:2016 - Medical Device Quality Management Systems 8
S What is the proper flow to feedback the defective found during QA sampling check? Quality Tools, Improvement and Analysis 8
Marc Tar balls found along shore in Key West - 18 May 2010 World News 6
H Elsmar Cove Statistics Found Online Coffee Break and Water Cooler Discussions 2
J Positive Corrective Action - 3 parts found out of 20,000 pcs 9 months after delivery Inspection, Prints (Drawings), Testing, Sampling and Related Topics 33
L No Trouble Found (NTF) concept applied in Automotive Industry Nonconformance and Corrective Action 6
A Injection Mold 100% Visual Inspection - Short Shots and Debris not being found Inspection, Prints (Drawings), Testing, Sampling and Related Topics 22

Similar threads

Top Bottom