SBS - The best value in QMS software

What questions should I ask during Internal Audits?

R

Ron Tollett

#11
#11
This very interesting, Jane. So in respect to Product Realization. Questions like, "Can you show me the process in which you produce an order?" or "How does in-process product move forward to the next operation?" Once I find the evidence, compare it to the procedure, correct?
 
Free Trial of DISCUS Desktop
Elsmar Forum Sponsor
Jen Kirley

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#12
#12
In case Jane doesn't get back right away, Ron you have pretty much summed it up.

But let us keep in mind that not everything requires a procedure and some procedures are so difficult to use that the auditing isn't simply about following procedure. In addition, procedures don't have to give every little detail.

It is about the process's effectiveness, of which definition plays a part; even if that definition is a clear and consistent description by auditees of what goes on and why, what the outcome is (including records as required, which you would verify), how the auditees can tell if it was good or bad outcome, and what to do if the outcome was not satisfactory.
 
J

JaneB

#13
#13
Ron tollett said:
This very interesting, Jane. So in respect to Product Realization. Questions like, "Can you show me the process in which you produce an order?" or "How does in-process product move forward to the next operation?" Once I find the evidence, compare it to the procedure, correct?
Click to expand...
Yes, exactly, you've got it. (Remember you may need to phrase questions in simple terms at times, rather than sound like a walking text book at all times).

And with the provisos that Jennifer added too! Not 'everything' is or even should be in The Procedure. Because any auditor should remember they are auditing a process (not just a procedure) and auditing part of a management system.
 
Q

qusys

Trusted Information Resource
#14
#14
Re: Internal Audit questions

Ron tollett said:
Thanks Gusys. If this was evidenced as being completed, would you say this would be considered effective in the activity/process?
Click to expand...
Hi Ron,
you are in, but remember to take in mind the objective and the scope of the audit to catch evidence to compare with the audit criteria to verify complaince or not.
You shall follow a a certain logical path, making ad hoc questions, but also verify records, look at the process and results .
Hope this helps:bigwave:
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
E Questions regarding Cpk Calculation - Should we be using LSL/USL or LCL/UCL? Capability, Accuracy and Stability - Processes, Machines, etc. 5
E Should I refuse to answer personal questions during the interview? Career and Occupation Discussions 59
K NCR (Nonconformance Report) - Basic questions - When should an NCR be filled out? Nonconformance and Corrective Action 5
W What is meant by Process Approach Auditing and What questions should be asked? Process Audits and Layered Process Audits 11
A VDA 6.3 should I apply the questions related to service provision VDA Standards - Germany's Automotive Standards 6
C UDI Questions on Control Units Other US Medical Device Regulations 6
M NFPA 70 electrical harness questions Various Other Specifications, Standards, and related Requirements 2
L Project Managers - Questions For You Career and Occupation Discussions 0
B Toyota PPAP Process - Three Questions APQP and PPAP 3
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
D Signature Matrix questions ISO 13485:2016 - Medical Device Quality Management Systems 4
D ECO (Engineering Change Order) process questions ISO 13485:2016 - Medical Device Quality Management Systems 7
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
D Shipping and recall questions ISO 13485:2016 - Medical Device Quality Management Systems 2
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 6
M Quality Metrics Questions Lean in Manufacturing and Service Industries 2
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
T AMS2570E certification equipment questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Mr Roo ISO 9001 - 7.1.3 Infrastructure - questions concerning evidence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
K AS9100 - 7.3 - Are these black and white questions with specific correct answers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Medical Device Identification & Codes - Article 27 Requirements questions EU Medical Device Regulations 1
Q Asset / Tooling Management - Two Questions Manufacturing and Related Processes 3
Q VDA 6.3 questions vs IATF 16949 clauses VDA Standards - Germany's Automotive Standards 0
I Questions to ask when auditing for Organizational Leadership and Planning for the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A ISO13485:2016 name and ownership changes questions ISO 13485:2016 - Medical Device Quality Management Systems 3
C CQA Test Questions Bank General Auditing Discussions 1
E Three basic questions about ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Informational EU – EMA revised guidance – Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 201 Medical Device and FDA Regulations and Standards News 2
M Informational EU – MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies Medical Device and FDA Regulations and Standards News 0
Ed Panek Relevant questions on Substantial Change Form CE Marking (Conformité Européene) / CB Scheme 3
K Beginner in ISO 45001 here! Three questions Occupational Health & Safety Management Standards 6
D Framing FDA Questions - Validation US Food and Drug Administration (FDA) 1
M Informational US FDA – Frequently Asked Questions (FAQs) About the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Medical Device and FDA Regulations and Standards News 0
F Barcoding questions - Is there a plain English primer for newbies? ISO 13485:2016 - Medical Device Quality Management Systems 10
D Questions about the contents of a Design History File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S ISO 14971 Risk Management - Questions for Hazard identification ISO 14971 - Medical Device Risk Management 2
M Informational EU – MDCG 2019-6 Questions and answers: Requirements relating to notified bodies Medical Device and FDA Regulations and Standards News 0
C MDR Importer/Distributor Definition Questions EU Medical Device Regulations 22
A Purchasing - Internal Audit Questions Internal Auditing 8
M Informational USFDA – Efforts to evaluate materials in medical devices to address potential safety questions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry Medical Device and FDA Regulations and Standards News 0
E Basic Risk based thinking questions Risk Management Principles and Generic Guidelines 5
F Job Travelers questions - unsigned operations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 41
J Training documentation - ISO 13485 audit and the auditor had questions General Auditing Discussions 7
G Auditor watching tech do procedure - Can tech ask questions? ISO 17025 related Discussions 6
A Any recommendation for ASQ's CPGP (Pharmaceutical GMP Professional) Certification exam questions? ASQ - American Society for Quality 2
M Informational EU – Questions And Answers Related To The United Kingdom’s Withdrawal From The European Union With Regard To Industrial Products Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom