Help trying to explain accuracy procedure

M

monpos

Registered
Hello,
I have an equipment that is sent to calibration with a certified supplier.
Auditor is asking about how the accuracy is reviewed and obtained. Our response is that the accuracy of the equipment is stated in the manual of the equipment and this information is provided to supplier.
The formula indicated in the manual is complex and requires knowledge of somebody with enough knowledge or experience.
However, auditor ask how we know that the accuracy is ok, the response is that we review the results provided for a certified supplier and if it is into the limits required is ok and we can use the equipment. However auditor insist on we explain the formula and how was obtained...is not enough provided a certificate of certified calibration lab ?
Of course we review that the certificate accomplishes with all requirements and we take actions according to results.
I will appreciate your feedback
 
N

ncwalker

A good way to convince yourself of a piece of equipments accuracy is to TEST it. Feed it known samples and evaluate if it is giving you the results you expect.

A good way to describe this is with a Gage R&R.

What kind of equipment are we talking about? What is it measuring? You will get better answers with more information.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Need Help With IATF 16949 Audit NC IATF 16949 - Automotive Quality Systems Standard 5
M Looking for kindly help... If there is any prohibits from contract manufacturing in US? About SR medical devices US Medical Device Regulations 0
Ed Panek Looking for help... FDA Pre Sub, IVD, Investigational level experience US Medical Device Regulations 0
A Help in rolling out a Quality Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T 5 Why's Help Needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 32
M Lead Auditor Log book Help. General Information Resources 1
J Help Needed Customer and Company Specific Requirements 1
P True position with bonus Excel help Manufacturing and Related Processes 8
G Help Needed: Quality Control / Assurance process Quality Manager and Management Related Issues 3
D Little Help with "Tooling Change Program" for perishable tooling (8.5.1.6) IATF 16949 - Automotive Quality Systems Standard 4
D Seeking help in validating a cleaning process. Manufacturing and Related Processes 5
A Help required in establishing Laboratory Information Management System as per ISO 17025, Cl.7.11.2 ISO 17025 related Discussions 0
R Help Understanding Current Role; Distributor, Manufacturer, or Importer EU Medical Device Regulations 4
D HELP gage card not popping up Using GAGEpack Software 2
bryan willemot Wanted: in need of start up Lock out Tag out program in Excel or Word, your help is much appreciated Occupational Health & Safety Management Standards 3
L Quality Manual Help for Service Sector/Service Organization (Government Contractor/IT Services) Quality Management System (QMS) Manuals 5
K Help with ISO 14971: Benefit-Risk Analysis ISO 14971 - Medical Device Risk Management 3
E Please help! ! I AM FRASTRATED SO MUCH! Should inactive ingredient be included in the unit formula if it is removed during the manufacturing process? US Food and Drug Administration (FDA) 0
A Help understanding what it takes to implement a QMS that is ISO 13485 compliant ISO 13485:2016 - Medical Device Quality Management Systems 4
T Need 5 why’s help AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
T Minitab Coding Help Using Minitab Software 0
G Help:Risk Management - Accessories US Food and Drug Administration (FDA) 1
T Containment help AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
Kevin Walters IAQG Required Audit Days Needed (Please help) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
T Need help understanding AS6174 clause 3.1.5. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R First Time Managing Calibration and Measurement System. Need Help. General Measurement Device and Calibration Topics 19
M Can someone help me with this CMM programming question? Manufacturing and Related Processes 2
C Need help in determining applicable clause for an audit finding (based on AS9120B) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Attempting to Poke Yoke a wire crimping process...need help Design and Development of Products and Processes 3
marmotte Help with Surgical Class I + 510(k) exemption US Food and Drug Administration (FDA) 0
T Help with updating procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
P Looking for help with an Ansys Workbench problem Manufacturing and Related Processes 0
C I need your help to find the action plan for these quality objectives Misc. Quality Assurance and Business Systems Related Topics 23
O New metal detector, ccp -help! Food Safety - ISO 22000, HACCP (21 CFR 120) 2
J PFMEA/control plan question- PLEASE HELP ! IATF 16949 - Automotive Quality Systems Standard 8
J Help needed on clauses identification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S HELP in setting-up QMS Quality Tools, Improvement and Analysis 4
R Need help on calibration result analysis Measurement Uncertainty (MU) 17
S Help in SMART goals AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Vader22 IATF 16949 extended manufacturing site help IATF 16949 - Automotive Quality Systems Standard 4
G Need Help with Run @ Rate for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 0
F Need help in IMS management review Management Review Meetings and related Processes 3
A Please Help With EOQ Calculation Manufacturing and Related Processes 2
S Help needed in choosing the method of calculating the minimum sample size Internal Auditing 12
D IATF 16949 Certification and Letter of Conformance expiry (Help!!!) IATF 16949 - Automotive Quality Systems Standard 8
S I need help in corrective action plan Nonconformance and Corrective Action 15
S Help in document control procedure Document Control Systems, Procedures, Forms and Templates 14
D Weird spec sheet - need help Measurement Uncertainty (MU) 3
Edward Reesor ISO 19223 Discussion (Help) Other Medical Device Related Standards 1
J Help to understand and response to API AAR during the re-certification audit Oil and Gas Industry Standards and Regulations 17

Similar threads

Top Bottom