SBS - The best value in QMS software

How to Identify "Observation" in Internal Audits?

RCW

Quite Involved in Discussions
#11
I had the same request of me also during a registration audit. The auditor wants me to define a major, minor and observation in my internal audit procedure. I think this is another case of dancing like a monkey for the auditor and I'm getting fed up with it. Do I not pay his salary for the audit?!?!
 
Elsmar Forum Sponsor
#12
I had the same request of me also during a registration audit. The auditor wants me to define a major, minor and observation in my internal audit procedure. I think this is another case of dancing like a monkey for the auditor and I'm getting fed up with it. Do I not pay his salary for the audit?!?!
Can I ask what you did in response?
 

RCW

Quite Involved in Discussions
#15
Seriously? Are you going to push it back...?
Probably not as it's a quick procedure mod. I already had a couple of verbal disputes with this auditor during the audit. I likely will be looking for another registar as this auditor replaced another auditor (same registrar) I had problems with.
 

John Broomfield

Staff member
Super Moderator
#16
RCW,

Remove the word Observation from your internal audit procedure and from your corrective action form.

Years ago ISO 19011 replaced this widely misused word with Finding (a statement of fact (good or bad) from the audit).

Refuse to toe any line drawn by an auditor unless the requirement comes from a legitimate source.

The auditor is not a legitimate source of requirements.

Once you start toeing their invented line the auditor will get worse.

So, warn your auditor not to provide any advice or invent any requirements as a basis for his or her reports otherwise you will ask their employer never to send them to you again.

Change the relationship so the auditor is convinced that you know what you are doing and you are not prepared to be pushed around.

What a stupid waste of time! :mad:

John
 
Last edited:

RCW

Quite Involved in Discussions
#18
RCW,
Years ago ISO 19011 replaced this widely misused word with Finding (a statement of fact (good or bad) from the audit).
Interesting that you bring this up. My experience with auditors has led to a "finding" as being bad (aka nonconformity). I've never heard it used as a good annotation.
 

Randy

Super Moderator
#19
Interesting that you bring this up. My experience with auditors has led to a "finding" as being bad (aka nonconformity). I've never heard it used as a good annotation.
I go immediately into correction mode if "finding" is mis-used in my training classes and I've actually corrected (privately) some folks I work with.

"I have a finding"...."Great! What type of finding is it?":frust:
 

John Broomfield

Staff member
Super Moderator
#20
Interesting that you bring this up. My experience with auditors has led to a "finding" as being bad (aka nonconformity). I've never heard it used as a good annotation.
RCW,

Is this yet more evidence of another poorly trained auditor or an auditor who stopped learning years ago?

Keeping up to date on terminology is an obligation for any professional (CPD).

...especially if we are expected to explain the subject matter or rely on uniform understanding of the applicable terms. :read:

John

PS, here is the definition of finding in full from ISO 19011 (equivalent to 3.9.5 in ISO 9000):

3.4
audit findings

results of the evaluation of the collected audit evidence (3.3) against audit criteria (3.2)

NOTE Audit findings can indicate either conformity or nonconformity with audit criteria or opportunities for improvement.
 
Thread starter Similar threads Forum Replies Date
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
T ISO 9001 8.5.2. - Identification and traceability to Identify Outputs - Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
U When do we identify Residual Risk? Risk Management Principles and Generic Guidelines 11
D How to Identify the Risks and Opportunities required for QMS Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D How to identify and confirm that the developed device fall under Israel electro medical device category Other Medical Device Regulations World-Wide 0
D How to identify and confirm that the developed device fall under Israel electro medical device category Other Medical Device Regulations World-Wide 1
E How do you identify what standards a country recognizes outside of FDA, EU, Health Canada Other Medical Device Related Standards 1
Marc Can you identify this moth? 19 January 2019 After Work and Weekend Discussion Topics 6
K Please help identify appropriate statistical treatment Statistical Analysis Tools, Techniques and SPC 13
D Help identify a Nationally Recognized Testing Laboratory (NRTL) (UL) certified lab General Measurement Device and Calibration Topics 3
T To Identify the Applicable MDD Directive - Prepared blood smear EU Medical Device Regulations 13
A Requirement to Identify Changes to record in ISO 13485 : 2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
R AS9100D Cl. 8.4.2 - Identify Raw Material as a Significant Operational Risk AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
C How to Identify Counterfeit Medications (drugs)? US Food and Drug Administration (FDA) 5
P How to identify the Management Representative ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
T How to identify requirements for 'Incoming inspection' Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
M How to identify software configuration items in a BOM Quality Manager and Management Related Issues 3
S Resource Planning/How to identify IATF 16949 - Automotive Quality Systems Standard 1
V How to identify Customer Specific Requirement If is not provided by Customer Customer and Company Specific Requirements 5
B How to identify Six Sigma Yellow Belt Project Six Sigma 4
C Must we identify steps taken to identify the Root Cause of a failure Nonconformance and Corrective Action 15
G How to identify Key Characteristics (KC) in a Design FMEA (DFMEA) FMEA and Control Plans 2
X Existing Toolroom Process Validation - Need to identify clauses addressed. Manufacturing and Related Processes 7
C How Can I Identify 304 Stainless Steel? Manufacturing and Related Processes 6
Geoff Cotton How to identify Stakeholders in a Company Quality Tools, Improvement and Analysis 9
M How to identify CTQ / Critical Characteristics using the DFMEA approach. FMEA and Control Plans 3
R 3rd Party Audit Comment - Identify ISO Clauses/Sub Clauses to each Process Quality Management System (QMS) Manuals 45
J AS9100:C Risk Management - Identify the Risk for the Sales/Contract Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
T How to Identify Taper Gages without potentially damaging them General Measurement Device and Calibration Topics 5
N How to Number (Identify) and Index Forms Document Control Systems, Procedures, Forms and Templates 1
A DoC for Software Product - How can I identify the specific units that are covered? EU Medical Device Regulations 6
X Audit Findings - The Process/Clause Matrix does not identify all the processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
S Identify Environment Aspect by Activities Approach ISO 14001:2015 Specific Discussions 4
T Can't identify my company's "Key Process" Process Maps, Process Mapping and Turtle Diagrams 27
B Effectiveness of 200% Visual Inspection to Identify Defects and Defectives Inspection, Prints (Drawings), Testing, Sampling and Related Topics 32
N Definition IDENTIFY and DETERMINE - What is the technical difference between the words Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 64
A Procedure to Identify Potential Emergency Situations and Accidents Miscellaneous Environmental Standards and EMS Related Discussions 4
D AS9102 - How to title the attached form and how to identify the characteristics AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
kedarg6500 How to Identify Critical to Quality Characteristics (CTQ) FMEA and Control Plans 2
Le Chiffre At what point do you need to identify a U.S. Agent - 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M New to AS9100 - Clause 7.5.3 - Do you have to identify each part produced AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Form to identify status of product on the production floor. IATF 16949 - Automotive Quality Systems Standard 5
L Special Characteristics - What if the customer does not identify any SCs? FMEA and Control Plans 5
M How do you identify the wrong orientation in complex wiring harness? Manufacturing and Related Processes 21
W How do you address clause 4.1 General requirements - Identify the processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
S CE Mark using Registered Trademark to identify the legal manufacturer EU Medical Device Regulations 6
B Determine vs. identify (as in clause 4.1 a), any differences? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B How to identify the processes needed for quality management system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
I Skill Matrix Format as a Tool to Identify Training Needs Document Control Systems, Procedures, Forms and Templates 1
F How Can I Identify any Drawbacks of 8D Problem Solving Methodology Quality Tools, Improvement and Analysis 5

Similar threads

Top Bottom