SBS - The Best Value in QMS software

New to performing internal audits - Looking for audit questions

C

Charlie H

#1
First off I hope this is in the forum.

I'm new to performing internal audits and only have two real audits and one practice one under my belt. The two real ones were both in a manufacturing area. I believe we will be performing an audit in the Purchasing and or Sales department(s) soon.

My questions are:
What types of questions have you (who ever answers) asked?
What do I look for in contract reviews?
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Looking for audit questions

First thing I do is look over the instructions (hopefully they exist) or procedures, and see if they address the requirements.

When looking at a procedure I often come up with questions based on what it says, even if it's only "please show me this." I also ask about what seems to be missing, such as "What happens if we can't do all the customer is asking for? - what do we do?" Look for:

- How people know what to do
- how do you know the information being worked to is current
- what happens to start the process (inputs)
- the process steps
- the end result (outputs)
- training and education that makes people ready to do the work
- records of what happened, especially communications
- tools like software or manuals.

What standard are you auditing to?
 
Last edited:
C

Charlie H

#3
Re: Looking for audit questions

ISO9001/AS9100 and I'm not sure if or how but coming soon 14001 (we are currently seeking implmentation).
 

Colin

Quite Involved in Discussions
#4
What questions to ask? - any that you feel will help you to establish that they are doing what the system says they will (i.e. following procedures), that these activities meet the appropriate clauses of the standard (7.2) and that the activities are effective in helping to meet the department's objectives.

What I don't recommend is simply asking for lots of documents. It should be an interactive process where you ask the auditee to tell you what they do and then check the documents to demonstrate they they do comply.

As for contract review, in a nutshell:

How do we know what the customer is asking for?
Can we meet those requirements?
How do we handle amendments to orders?
How do we communicate with customers before, during and after the order?
How do we handle feedback, including complaints?

In all of the above, there should be evidence available to demonstrate what they actually do, as opposed to what they and the procedure says they do.
 
#5
This topic has been covered at length, however, in a nutshell:

What's the process?
What's the objective?
How's the process measured?
How is it performing to objective right now?
What are your actions to correct/improve performance?

Don't forget, you have to study beforehand. You should already have a good idea what the process, objectives etc are. When you get answers you an compare that to what you already know. If there's a difference, you can find out why and if it's significant. If not, it must be OK.
 
M

mahasatta2002

#6
What is the purpose/objective for conducting Internal Audit?

Verification whether one is meeting the requirements of the standards as

documented in the Quality Manual,looking at procedures,work

instructions,forms and formats and finally records as an evidence of

compliance.

When an auditor goes to a particular dept the documentation related to

the dept is seen and then compliance verified with regards to what is

stated as a mark of committment.

The questions asked are the 5 Ws and 1 H and finally SHOW ME the

records as a documentary evidence to come to the conclusion whether

there is compliance or not.

As an auditor have a firm belief that, Internal Audit is a very important

tool and if a strong Internal Audit is done it helps the organisation

tremendously and has to lead to continual improvement.
 
Thread starter Similar threads Forum Replies Date
D External Parties performing Internal Audits? TS 16949 Clause 8.2.2 IATF 16949 - Automotive Quality Systems Standard 15
S Performing Internal Audits as per Canada MDR GD 210 Internal Auditing 7
C Are there any special requirements for performing internal audits to AS9100B Internal Auditing 0
G Performing Internal Audits by Phone? Multiple International Sites Internal Auditing 6
B Thoughts on performing an ISO 9001:2015 Remote Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J Performing Internal Calibrations - Dial gauges, micrometers, height gauges, calipers General Measurement Device and Calibration Topics 8
D Performing Internal Audit of our Accounts System Internal Auditing 4
G Performing an Internal Audit on the Cost Estimating Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
Marc Sample Size in Auditing - Percentage audited when performing an internal audit Internal Auditing 8
Geoff Cotton Performing a Delta Audit General Auditing Discussions 12
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
I Root Cause Analysis when someone simply stops performing a task? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
K ISO 17025:2017 clause 7.6.2 - Performing calibration of its own equipment shall evaluate the measurement uncertainty ISO 17025 related Discussions 6
H Question about implications of performing Firmware upgrade via MDDS - Medical Device Data Systems 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Justifications for not performing MSA (Measurement System Analysis) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
V Sequence of performing risk assessment: User_FMEA (User Errors) vs Design Inputs FMEA and Control Plans 1
Y Performing product audits in a manufacturing facility Manufacturing and Related Processes 13
A ISO 9001:2015 - How to apply 7.1.5 to an organization performing only design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Performing PQ on a Small (tabletop) Air Heat Treating Oven ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
H Performing a TUS on a Furnace used at One Temperature - AMS2750-E AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 27
drgnrider EMR performing audits of EMS Miscellaneous Environmental Standards and EMS Related Discussions 13
C Performing an ISO 9001 based Supplier Audit - Multiple Supplier Facilities Supplier Quality Assurance and other Supplier Issues 4
D Performing a Gage R and R with No Specification Range Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
C Going Rate for Performing a Supplier Audit? Consultants and Consulting 1
B Performing MSA on Straightness of a Cylinder Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 13
C Performing a MSA as it relates to Calibration Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
J Performing a MSA on a new gauge using different parts Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
K Production Operators Performing GP12 (General Motors Containment) Customer and Company Specific Requirements 2
L How is the interaction physically happening while performing ANOVA GR&R? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
E Exam for Personnel performing Calibration General Measurement Device and Calibration Topics 7
B Performing a Gage R&R Study with Minitab 13 Using Minitab Software 5
M Requirements for Laboratories performing ASTM Tests Various Other Specifications, Standards, and related Requirements 4
J 5.15 or 6 Sigma? What multiplier to use when performing a Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
A SOP for performing Annual Product Reviews for Medical Device and Pharma Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
D Severity or Occurrence? Performing an FMEA on Motorcycle Operation FMEA and Control Plans 9
K Performing PPAP Retroactively APQP and PPAP 8
H Proprietary Processes - How to Protect and still comply when performing an FAI? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
JoCam Budding Consultant: What to charge for performing a desktop study. Career and Occupation Discussions 10
Miner Upcoming article - Within-part variation when performing an R&R Imported Legacy Blogs 6
E Minimum data for performing an Anderson Darling Test Statistical Analysis Tools, Techniques and SPC 1
A Difficulties in performing MSA on Rockwell Hardness Tester Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 20
6 Badly Performing Packaging Machines Manufacturing and Related Processes 1
D People Management - Managing an under performing subordinate Career and Occupation Discussions 15
A Competence for performing compliance audits - 4.5.2 Miscellaneous Environmental Standards and EMS Related Discussions 6
P For business performing PRODUCT DEVELOPMENT ONLY, what is best QMS for certification? Quality Manager and Management Related Issues 2
A Justification for not performing overseas supplier audit General Auditing Discussions 6
A Performing Ring Gage Calibration General Measurement Device and Calibration Topics 5
E Hypothesis Test - Determining if a second wash is worth performing Statistical Analysis Tools, Techniques and SPC 7
S Performing Investigation of used returned expired devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Guidance in Performing a 13485 Gap Analysis ISO 13485:2016 - Medical Device Quality Management Systems 8

Similar threads

Top Bottom