Question for Auditors on 7.1.4 in the ISO9001:2015 revision

ScottK

Not out of the crisis
Staff member
Super Moderator
#1
So 7.1.4 specifically calls out psychological environment...

Are you actually monitoring that? And how, without education in social work or psychology?

What would you do if you were auditing a company and you observed things like:
- So-and-so manager quit because the stress was too much (and you learn that he was the third in 4 years in that position)
- The QA management leaves and has to be replaced about every 18-24 months
- yelling fights clearly audible through office doors
- "HR is useless in advocating for stress reduction"
 
Elsmar Forum Sponsor
#2
So 7.1.4 specifically calls out psychological environment...

Are you actually monitoring that? And how, without education in social work or psychology?

What would you do if you were auditing a company and you observed things like:
- So-and-so manager quit because the stress was too much (and you learn that he was the third in 4 years in that position)
- The QA management leaves and has to be replaced about every 18-24 months
- yelling fights clearly audible through office doors
- "HR is useless in advocating for stress reduction"
It's just a note... Not a requirement.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#3
It's jut a note... Not a requirement.
the note gives things to consider when reviewing this requirement, right?
Why make it a note if it's to be ignored?

Would any auditor say anything if something like this came up in an audit?
If turnover is particularly high doesn't this indicate a problem with the environment of other sources complain of a stressful workplace?
 
#4
the note gives things to consider when reviewing this requirement, right?
Why make it a note if it's to be ignored?

Would any auditor say anything if something like this came up in an audit?
If turnover is particularly high doesn't this indicate a problem with the environment of other sources complain of a stressful workplace?
Nope. I worked at a place which had a 80% turnover in the first 30 days of hiring. Nothing to do with stress... By the time we got done with implementing a QMS, it went to 80 retention.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
What would you do if you were auditing a company and you observed things like:
- So-and-so manager quit because the stress was too much (and you learn that he was the third in 4 years in that position)
- The QA management leaves and has to be replaced about every 18-24 months
- yelling fights clearly audible through office doors
- "HR is useless in advocating for stress reduction"
From an employee/associate mental health well being this is something that clearly falls in the scope of ISO 45001, not 9001.

As a QMS auditor, if I follow an investigation trail that shows quality problems/customer dissatisfaction issues that are a (direct) result of extreme turnover, I would ask questions. But remember, auditors are not supposed to delve into the root cause analysis of the problem. Even if the organization's root cause investigation leads to a consensus that high turnover is due to unbearable mental stress in the workplace, company might decide that the solution is to hire people who are less "touchy-feely" and more tough skinned...

As an auditor, I may connect the dots because it is extremely unlikely that an organization that subjects it's workforce to this type of environment would really be concerned with customer satisfaction, but I have to stick to evidence at hand and the proper auditing protocols.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#6
Nope. I worked at a place which had a 80% turnover in the first 30 days of hiring. Nothing to do with stress... By the time we got done with implementing a QMS, it went to 80 retention.
I'm suggesting that stress as a reason for turnover has already been indicated by auditees in the course of the audit...
 
#7
I'm suggesting that stress as a reason for turnover has already been indicated by auditees in the course of the audit...
The problem with people is we all have different perceptions of what stress is. In the auto industry, being in a staff function means you work 50 hour weeks. They say you never leave a bad job, you leave a bad boss - I can vouch for that - but the stress level of the job wasn't different with different bosses.
 
Thread starter Similar threads Forum Replies Date
M Question for Auditors - "Off the Record" Conversation? General Auditing Discussions 14
Mohammed Gouda Old calibration standard methods - Question for ISO 17025 auditors..... ISO 17025 related Discussions 1
ScottK Remember Auditors - It's all in how you ask the question! Coffee Break and Water Cooler Discussions 1
A Question regarding TS16949 auditor rules 3.3 - Different auditors IATF 16949 - Automotive Quality Systems Standard 4
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
A Quality engineering positions in US - question Job Openings, Consulting and Employment Opportunities 1
D Equipment Register related question ISO 13485:2016 - Medical Device Quality Management Systems 1
S Study sign off question / responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 3
S Qualification question - ISO 13485 Reliability Analysis - Predictions, Testing and Standards 0
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
A Question on Authorized Representative in Malaysia Other Medical Device Regulations World-Wide 3
D Limited Scope for second site Question? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
Anonymous16-2 Labeling Question (Dietary Supplements/Food) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
T Question for: Cg & Cgk calculation General Measurement Device and Calibration Topics 3
N ASL Question for GitHub ISO 13485:2016 - Medical Device Quality Management Systems 6
hogheavenfarm GDT Flatness measurement question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 8
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Another DFAR question 252.225-7009 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
F Conflict Mineral Smelter Question RoHS, REACH, ELV, IMDS and Restricted Substances 8
R NRTL - Scope Question - Off-the-Shelf Plug In IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D API 6A Certification Question Oil and Gas Industry Standards and Regulations 4
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
R DHR question: Traceability of components ISO 13485:2016 - Medical Device Quality Management Systems 2
C MDR - Question around software accesories EU Medical Device Regulations 2
K My question is, what/when is a nonconformity? Therefore what requires an NCR? Nonconformance and Corrective Action 9
Watchcat Authoritative References about the Research Question? Quality Tools, Improvement and Analysis 0
T Question about Quality Department employee position titles Quality Manager and Management Related Issues 10
N Question on creepage/clearance requirements for HF Active Accessories for 2nd edition 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
I Question 1 - Nitpicking on Document Approval - can a document approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Question: How to create an IMDS RoHS, REACH, ELV, IMDS and Restricted Substances 3
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B QMS question in regards to multiple medical devices/products and N/A activities Other Medical Device Related Standards 12
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10
G Question about Non-conformances during New Product Introduction Nonconformance and Corrective Action 14
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
O Mitutoyo Digital Caliper to PC USB question General Measurement Device and Calibration Topics 2
R Probability - Need a help to solve the below question Statistical Analysis Tools, Techniques and SPC 5
B Minitab Type 1 Gage Study on True Position Question Measurement Uncertainty (MU) 1
Q Supplier audit question cataloque VDA Standards - Germany's Automotive Standards 0
Ed Panek Inactive key supplier question - We are not actively buying from them ISO 13485:2016 - Medical Device Quality Management Systems 2
T Potential Off-Label Use question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R Question on determining defective units - I am not recording fixture to part rejected Statistical Analysis Tools, Techniques and SPC 5
Ed Panek Rule 11 Question - CE approvals for software as well as the medical device EU Medical Device Regulations 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
D Company Moving - Relabelling Question Medical Device and FDA Regulations and Standards News 0
Ronen E Tolerance intervals (?) question - Flow Rate Probability Range Statistical Analysis Tools, Techniques and SPC 6
S Conformity Assessment Route question for Class IIa medical device under MDR EU Medical Device Regulations 3

Similar threads

Top Bottom