Is Automated Internal Auditing Possible?

Mark Meer

Trusted Information Resource
#11
Technologically possible someday no doubt, but in 2017 A.D. the Standard says the organization shall do the audit.

Organization = person or group of people in 9000:2015.
If the software is simply a tool, and a person has to initialize it, couldn't it be argued that it's still a person doing the audit (using a time-saving tool)?

:popcorn:
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#12
I would have thought that there'd be a lot of resistance to the idea of automation...
Apparently, resistance is futile... :)

Just to keep the discussion going, can someone provide examples of where / how automated auditing could be done? Are we talking more like compliance of procedures to the standard or confirming required records are collected and controlled (maybe irrespective of content)?

I'm certainly not resistant to the idea but I'm curious where folks see the opportunity.
 

Mark Meer

Trusted Information Resource
#13
Just to keep the discussion going, can someone provide examples of where / how automated auditing could be done? Are we talking more like compliance of procedures to the standard or confirming required records are collected and controlled (maybe irrespective of content)?
I was thinking, any instance where requirements (whether from standards, or internally specified) can be boiled down to simple checks. For example:
  • Management review & internal audit shall be held according to established schedules
  • All records shall be dated
  • Records shall be maintained for at least 5 years
  • Documents shall be approved prior to use
  • Manufactured units shall be authorized for release prior to shipping
  • Authorization for use-as-is non-conformances shall be signed and dated

...you get the idea. Basically, assuming all data is recorded and maintained digitally, such conformance checks could be automated.
 
R

randomname

#14
You're headed in the right direction. An easy way to do it is to identify data sources that are computerized, where auditors would normally trace back to them. But instead, we have the computer do a check for us.

Common examples of data sources might be qualifications for each employee, maintenance database, calibration database, approved supplier list, inspection or other verification/approval records for incoming material ...

So,

- if someone performs a test and they are required to provide traceability back to the test device by entering the S/N, have the system search the calibration database to make sure it is within its calibration window

- if a piece of equipment (again, perhaps S/N) is entered into a production records for something being produced, have the system search the maintenance database to make sure it's within its maintenance period

- when someone enters the supplier ID and/or batch # for raw materials about to be used, have the system check to make sure the supplier is still considered qualified and/or that the batch # has actually been approved/released for use

- if a computer user is using a particular application, have the system check to make sure that individual (e.g., based on their sign in to the system) is qualified to do that job by checking training database

- if someone performs an audit have the system check to make sure they are independent of the area(s) to be audited

......
 
Thread starter Similar threads Forum Replies Date
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
L Gage RandR on automated equipment. IATF 16949 - Automotive Quality Systems Standard 7
Ron Rompen MSA on automated measurement system - Multiple Step Vision System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Images of Product for Automated Process - How long to keep? US Food and Drug Administration (FDA) 2
T Correct MSA study for an automated camera system which makes attribute inspection Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
M Applicability of Means of Protection, working voltage in an Automated External Defibrillator IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
T Tests IEC 60601-1 - Grounding Resistance, Leakage Current and Dielectric Rigidity in an automated way IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Ron Rompen GR&R on Automated Inspection Cell Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 15
S What are you looking for in an automated quality management system? Quality Assurance and Compliance Software Tools and Solutions 8
F Automated Platform (IVD) Classification/Registration (New to RA) EU Medical Device Regulations 3
A Automated Measurement Machine MSA - Small Parts Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
T Automated and Manual Measurement System Comparison (Correlation) Quality Tools, Improvement and Analysis 3
Crimpshrine13 MSA for a part Automated and part Manual Inspection Machine IATF 16949 - Automotive Quality Systems Standard 7
B How to do an MSA on an Automated Torque / Angle System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
A Automated calibration of Digital Multimeter without communication port Calibration and Metrology Software and Hardware 2
S Bench Marking Automated Data Collection Benchmarking 4
C How to perform Gauge R & R on Automated Test & Measurement Equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
P Looking for recommendations for an automated vision measuring system Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
M Automated Revision Updates - Notifications of new revisions for ISO's to subscribers Document Control Systems, Procedures, Forms and Templates 2
T Tools Six Sigma for my Automated Machine Six Sigma 8
C Gage R&R on In-Process Automated Inspection Equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 13
Q 21 CFR 820.30 - Automated with Computer Software - Applicable? US Food and Drug Administration (FDA) 5
S How to calibrate AOI (Automated Optical Inspection) for IOPQ Qualification and Validation (including 21 CFR Part 11) 3
P GR&R on automated test system which produces hundreds of results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
C Multiple Variation Gage R&R for Automated Testers Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
J Classes for Hydraulic Calibration - Dead Weight Tester or Automated Controller General Measurement Device and Calibration Topics 1
Q Automated Test Software and System Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L Automated Calculators like EXCEL sheets for different processes Quality Assurance and Compliance Software Tools and Solutions 2
L Dry Lube Application (Ever lube 620) - Manual Application vs. Automated Spray Process Manufacturing and Related Processes 1
E MSA (Measurement System Analysis) Study on an Automated Process Quality Tools, Improvement and Analysis 4
Hami812 Gage R&R on Automated Tool that supports Pass/Fail and some Parametric Testing Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
G Automated Production Line Quandary... FMEA and Control Plans 1
R Use of Automated Liquid Handling Robot for a PCR based Assay CE Marking (Conformité Européene) / CB Scheme 2
D Automated Vision Systems - Cost, Value and Payback of Implementation Statistical Analysis Tools, Techniques and SPC 2
I Gage R&R for Automated Measurement Equipment Systems Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
A Classification of Automated Gait Training Device for Rehabilitation EU Medical Device Regulations 5
R GAMP (Good Automated Manufacturing Practice) simplified please. Quality Manager and Management Related Issues 3
G Is Agilent?s automated network analyzer verification ISO/IEC-17025 compliant? ISO 17025 related Discussions 4
T Gage Repeatability for an Automated Leak Tester Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
sagai Automated System's Signature on Electronic Record - PART11 Qualification and Validation (including 21 CFR Part 11) 4
C Multiple Fixture Automated Vision System GR&R (Gage R&R) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
M GR&R (Gage R&R) for Automated Electrical Testing Equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
B Automated paint process control on conveyerized lines - Million dollar question Capability, Accuracy and Stability - Processes, Machines, etc. 14
Q Validating the AOI process (Automated Optical Inspection) Reliability Analysis - Predictions, Testing and Standards 9
S Automated regression testing software Software Quality Assurance 4
C MSA (Measurement System Analysis) on automated machine Capability, Accuracy and Stability - Processes, Machines, etc. 1
B Automated Testing - R&R study - calculation Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
S Attribute Gage R&R - Automated Test Equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
R Attribute Gage R&R analysis - Automated test system Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5

Similar threads

Top Bottom