Approach to Internal Auditing

E

eee

#1
#1
Before the beginning of a planned audit in one of departments we suggest them ( Manager, his Deputy, one-two specialists on middle level management and Supervisor) to fill out a special form named "What is the process in your department?". It's a kind of self-assessment. Then we collect these forms and analysed differences in their answers. They are always occured! It is a good input to the following audit. It seems like an evidence of understanding the System. Then our auditors put their efforts to find the causes of misunderstandings and eliminate these differencies. We are sure this approach brings value-adding to our internal audit system. The main problem is to change these questionnaries every planned audit year in order to make them (see ab.) think from various points of view.
What do you think about such approach?
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
M

M Greenaway

#2
#2
Interesting

It would normally be one of the first questions of an audit anyway. It may yield some important signals, but the differences might just be simple mis-understandings in detail. Do you still audit compliance of the process to ISO9000, or is it just an audit of management understanding of their processes ?
 
E

eee

#3
#3
If we consider cl. 8.2.2 it is more important for us to comply para. b) and then a), i.e we need to ensure that our system is effectively implemented and maintained. An understanding of all participants of the process of what is done is a milestone of this ensurance. Today we are sure that our system is in compliance to the requirements of ISO 9001. It is confirmed by external audits.
 
M

M Greenaway

#4
#4
I am amazed that so many people in this cove do not conduct internal audits to the requirements of the standard. Reliance on external auditors adequately performing this function is in my humble opinion naive. Also this reliance effectively puts your ISO9000 certificate on the line at every external audit, not to mention the inadequacy of external audits.
 
E

eee

#5
#5
"Inadequacy" - you are right!
JOurHO such xternal audits don't add value to our system. 70% of n/cs are "the form ¹.. is filled not in accordance with SOP". We do such findings better. But we are proud of our Certificate and sure that it should be valid till next 2 years. To comply to Standard req's isn't a problem for us.
 
D

db

#6
#6
Good first step

I agree with Martin that it is a good first step. But to go beyond that, if they really look at the process, not just fill out the form, then it could also be a strong tool for improvement.

Martin, I for one feel that auditing must be both process and system focused. Just looking at the process might not yield some information that auditing to the standard would reveal. If our goal is truly continual improvement, we must look at (read audit) our system from a variety of different ways.
 
Claes Gefvenberg

Claes Gefvenberg

Admin
#7
#7
It would normally be one of the first questions of an audit anyway.
Click to expand...
Same here. We always ask people to describe what they do and how.... If nothing else it sets the audit off in a positiv way: People like to tell you about what they do, and you frequently get answers to some other questions on the fly.

As for the original question, it can't be a bad thing to get peole thinking about the audit *before* you get there.

/Claes
 
Last edited:
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
C The Holistic Approach to Internal Auditing (ISO 9001) Internal Auditing 14
D Internal Auditing ? A Practical Approach General Auditing Discussions 4
V Process approach based internal auditing Internal Auditing 1
W Internal Auditing of individuals - Can anyone suggest a format or approach? Internal Auditing 19
Pmarszal ISO 19011:2018 - Risk Based Approach for planning, conducting and reporting of internal audits Internal Auditing 8
Howard Atkins Process Approach Requirement for Internal Audits in TS 16949 IATF 16949 - Automotive Quality Systems Standard 46
B The correct approach to calculating Internal Scrap ppm Statistical Analysis Tools, Techniques and SPC 3
J Internal Audit format - Idea of the process approach to the audit Internal Auditing 16
B Internal Audits - Changing from Check Lists to Process Approach Internal Auditing 13
E Internal Audit - FMEA approach Internal Auditing 3
H Process Approach - Internal Audits - Example Check List Attached Internal Auditing 11
M 'Process Approach' to ISO 9000 Internal Audits - Identify an 'owner' for each process Internal Auditing 15
W Bracketing approach Problem Solving, Root Cause Fault and Failure Analysis 0
W Equipment Bracketing Approach US Food and Drug Administration (FDA) 0
I PFD (Process Flow Diagram) approach. Setup details as part of PFD? APQP and PPAP 5
T How should I approach REACH, CM, etc. as a job shop? RoHS, REACH, ELV, IMDS and Restricted Substances 18
A Migrating from whole product CE marking to modular approach CE Marking (Conformité Européene) / CB Scheme 5
D CE SaMD modular approach CE Marking (Conformité Européene) / CB Scheme 5
K MDSAP Audit Approach 2020 for Brazil Other Medical Device Regulations World-Wide 1
K MDSAP Audit Approach 2020 ISO 13485:2016 - Medical Device Quality Management Systems 4
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Qualification and Validation (including 21 CFR Part 11) 5
G Any good examples of CAPA forms that include a risk based approach? ISO 13485:2016 - Medical Device Quality Management Systems 8
qualprod Best approach to get a real value as average? Statistical Analysis Tools, Techniques and SPC 6
DuncanGibbons FAA's Building Block approach to certification Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
G New CAPA Work Flow with Revised 8D Approach Process Maps, Process Mapping and Turtle Diagrams 35
R Bottom up approach versus system level ISO 14971 - Medical Device Risk Management 2
D Validation of existing equipment - Risk based approach example ISO 13485:2016 - Medical Device Quality Management Systems 3
qualprod Shortening processes complying with process approach ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
O Validation approach for a Photostability Chamber (used for fluid therapy and injectable drug products) Qualification and Validation (including 21 CFR Part 11) 1
Sidney Vianna NASA to Develop a Novel Approach for All-Electric Aircraft Using Cryogenic Liquid Hydrogen as Energy Storage World News 2
tony s What is the automotive process approach for auditing? IATF 16949 - Automotive Quality Systems Standard 2
C Usability IEC 62366-1:2015 and MDR 2017/745 - Risk based approach IEC 62366 - Medical Device Usability Engineering 1
M Informational EU – Medicinal products and medical devices: Coordinated approach in case of a withdrawal of the United Kingdom from the Union without a deal 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
M APQC PCF (Process Classification Framework) and ISO 9001 - Processes Based Approach ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Risk Approach doesn't address External Issues (Auditor's Comment) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
Q Questions about the Risk-based approach to QMS processes ISO 13485:2016 - Medical Device Quality Management Systems 17
N Do I need to approach galvanized steel sheet flatness issue with DOE? Problem Solving, Root Cause Fault and Failure Analysis 9
S ISO 13485:2016 - Risk-based Approach ISO 13485:2016 - Medical Device Quality Management Systems 3
S Risk based approach - Procedures already take a risk-based approach to QMS processes ISO 13485:2016 - Medical Device Quality Management Systems 3
S IATF 16949 - Manufacturing and Product Audit Approach IATF 16949 - Automotive Quality Systems Standard 19
S ISO 13485:2016 - How I can integrate a risk management approach in our SOPs ISO 13485:2016 - Medical Device Quality Management Systems 1
S Risk Based Approach for ISO 13485:2016 Form/Procedure ISO 13485:2016 - Medical Device Quality Management Systems 23
P Best approach to tackle difficult certifications Career and Occupation Discussions 2
C Does Japan accept the Bracketing Approach for Process Validation Japan Medical Device Regulations 1
A How to approach ISO 9001:2015 Clause 7.1.6 when 3rd Party Auditing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
alonFAI How to define a Risk Based Approach for Supplier Management per ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
B Risk Requirements to meet the explicit Risk Based Approach of ISO 13485:2016 Examples ISO 13485:2016 - Medical Device Quality Management Systems 21
A How do we implement a Process Approach ISO 13485:2016 - Existing GMP QMS Other ISO and International Standards and European Regulations 2
V When and How to apply the Bayes Success Run approach for Sample Size Determination Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4

Similar threads

Top Bottom