SBS - The best value in QMS software

Justification for Month End Calibration Date

Elsmar Forum Sponsor

Mike S.

Happy to be Alive
Trusted Information Resource
#12
If you have a situation like the OP I would ask the auditor politely to "show me the shall". If someone is writing a NC the first thing to do is to list the requirement, aka "the shall".
 
#13
Unfortunately Our company works a little different, our internal auditors are requesting (Demanding) this and no matter how we try it seems not good enough. I've ran this system at multiple companies and have never had to justify this. They're wanting an individual asset by line item assessment. I'm hoping someone out there has come up with a way to justify it by not doing individual assessments. Thanks for any help you can give me.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#14
Are your internal auditors company employees? Or are they outside the company hired in for the job?

If employees...have management push them back. (ie. swing the bat)
If outside...document the input, write your defense as to why it is inappropriate and find someone else to audit from now on...
 

Mike S.

Happy to be Alive
Trusted Information Resource
#15
I would definitely take this to a higher authority. No auditor worthy of the title will demand something or write a NC for something that is not required. With no requirement (shall) there is no NC. If there is a requirement, let the auditor specify the requirement, that is part of their job. Without the requirement, how can you develop a compliant system via corrective action?

"Auditors" like this give auditing a bad name.
 
#16
Well Mike S, I agree with you on all points but unfortunately this is an internal auditor and I can't tell them that. Our auditors require Justifications for everything they do not understand, which unfortunately most people do not understand calibration. They want me to show that the additional days won't make a difference. I tried going the confidence route but that didn't give them the warm happy feeling their looking for, I don't have the time to do a real study so if anyone has a something they pulled off the information would be extremely helpful, our auditors didn't bring up their concerns until after we made schedule changes.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#17
Well Mike S, I agree with you on all points but unfortunately this is an internal auditor and I can't tell them that. Our auditors require Justifications for everything they do not understand, which unfortunately most people do not understand calibration.
You have the other way around. The auditee can not be responsible for educating the auditor on each and every issue they don't understand. As already mentioned, it is the auditor's responsibility to identify the requirement not being complied with. If there is no explicit requirement being violated, at best, the auditor identified some "risk". Who determines if the risk is acceptable or not should be the people with the understanding of the situation.

Measurement devices don't go bad the day after the calibration date expires. Frequency of calibration determination, when well executed, takes into account several parameters such as device calibration stability, frequency of use, storage, usage and handling conditions, criticality of the measurements being undertaken, etc.

If you allow auditors, internal or external, to dictate risk management decisions they are not equipped to make, you are doing your organization a huge disservice.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#18
Scubabiker03, maybe I am reading this wrong, but you may be inexperienced and/or a bit intimidated. If so, we have all been there. But between Ninja, Sidney, and myself you probably have well over 70 years worth of experience advising you. This kind of thing will go on until someone puts a stop to it. If the Lead Internal Auditor won't step in and stop this BS, I strongly suggest you raise it to the next level of Management. JMHO.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#19
20 yrs here...so I think the total is higher than 70yrs.
FWIW, I come from the "getting audited" side of things...and I've had to push back hard on some auditors who were out of line.

My first audit was extremely intimidating, and I laid down and took it because I didn't know any better.
When I had learned better, I realized that I didn't have to be intimidated...these "should be" people who are trying to help your company by finding what's broken so you can fix it.
No one likes being told they did it wrong (especially if you haven't done it wrong)...you have to keep your brain engaged and reality check any potential finding...NEVER just lay down and take it...learn, or teach, or learn together using only the standard (which includes your internal docs by reference).
 
#20
Mike, I actually have been in the business for 35 years, but I was informed by my leadership that this is an internal requirement, not external, so I must do this. It makes no sense to me but I don't have a choice in this matter.
 
Thread starter Similar threads Forum Replies Date
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
B Per 21CFR 820.198 (b) - Justification for no investigation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 22
M CER Adverse events - Justification of databases searched EU Medical Device Regulations 5
P IATF 16949 Clause 8.4.2.3 - Justification for non-certified suppliers IATF 16949 - Automotive Quality Systems Standard 14
O Statistical justification of sampling size in V&V tests ISO 13485:2016 - Medical Device Quality Management Systems 5
V Statistical basis and justification while comparing / changing sampling plans Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
J Calibration Justification - Requirements for Measurement with a Calibrated Device General Measurement Device and Calibration Topics 1
SATHYABALARAMAN Exclusion of IATF 16949 Clauses - 8.5.5.1 & 8.5.5.2 & Justification IATF 16949 - Automotive Quality Systems Standard 9
N Sample Size Justification for Medical Device Shelf-Life Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
M Justification for Not Having a Validation Plan for a Critical Process ISO 13485:2016 - Medical Device Quality Management Systems 4
B EMC Repeat Justification - Reducing NRTL testing required after modification of ME IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Biocompatibility omission justification for FDA 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
G Exemption Filing / Exemption Justification RoHS, REACH, ELV, IMDS and Restricted Substances 9
H Factory Dictated Sample Size Justification Statistical Analysis Tools, Techniques and SPC 9
J Justification for Exclusion of Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 8
S Justification of Lifetime of a Medical Device including Component Aspects ISO 13485:2016 - Medical Device Quality Management Systems 13
C Justification for No CAPA in Complaint Files Nonconformance and Corrective Action 24
Q Sample Size justification for IEC 60601-1 Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Wes Bucey A justification to take HR out of hiring Career and Occupation Discussions 3
S Establishing an MSA Plan and Justification Suggestions wanted Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
G Sampling Plan - Sample Size Justification for a Bottling Cleaning Process Validation Qualification and Validation (including 21 CFR Part 11) 2
X Justification of Decrease in Receivables, Increase in Negative Cashflows Coffee Break and Water Cooler Discussions 2
J Sampling Plan Justification and Rationale Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
S MDR (Medical Device Reporting) Justification - Canned Statements Other US Medical Device Regulations 2
P Out of Tolerance Gage - Justification for not Recalling Product Misc. Quality Assurance and Business Systems Related Topics 7
Wes Bucey Justification for organization's tax-exempt status? Funny Stuff - Jokes and Humour 1
C Looking for Skills Matrix & Justification of skill levels. Document Control Systems, Procedures, Forms and Templates 5
A Justification for not performing overseas supplier audit General Auditing Discussions 6
Q Justification/Rationale for not investigating a nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 19
P Reference Only Gages - "For Reference Only" Rationale (Reasoning/Justification) General Measurement Device and Calibration Topics 25
G Justification for Supplier Quality Engineer Career and Occupation Discussions 3
M Justification for not doing Gage R&R Studies Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
J Medical Device FMEA Occurence Rating Scale Justification FMEA and Control Plans 3
J What would be the justification for exclusion of ISO9001 clause 7.5.1? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
J Software Justification in a Lean Environment - Convincing Management Lean in Manufacturing and Service Industries 12
R Frequency of self control and costs - Justification for 4 Hours vs. Every Hour IATF 16949 - Automotive Quality Systems Standard 2
N CE Mark Auditing - All they had for CE was a written Technical Justification EU Medical Device Regulations 5
R Cost Justification Based Upon Intangibles - Cost of Quality Misc. Quality Assurance and Business Systems Related Topics 4
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 2
B IATF 16949 News Six month extension on all valid IATF 16949 certs IATF 16949 - Automotive Quality Systems Standard 10
A API Spec Q1 9th Edition - 12 month Internal Audit Schedule Audit Nonconformance Oil and Gas Industry Standards and Regulations 10
D QMS Performance Based on how many NCRs were generated month to month Nonconformance and Corrective Action 8
D Can an AS9100 auditor issue an NCR a month after the audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
J New position and AS9100 audit is 1 month away- need advice AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Colin I am retiring at the end of this month - March 2017 Coffee Break and Water Cooler Discussions 19
C Calibration Dates - Exact day or end of month? General Measurement Device and Calibration Topics 24
O New Job 1 Month from Recertification Audit - Missing Documents, no Internal Audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
Randy Looky here - Check out my 9-month old Great-Grandson Hayden Coffee Break and Water Cooler Discussions 4
SATHYABALARAMAN Quality Month - November 2012 Imported Legacy Blogs 3

Similar threads

Top Bottom