SBS - The best value in QMS software

What direction do you provide your internal auditors on OFIs?

John Broomfield

Staff member
Super Moderator
#21
In an internal audit, who is the "client"? Why would anyone have to be paid?
The client for internal audits is top management. They may elect for their internal audits to include auditor recommendations or not.

In my experience most do not.

And the claimed demand for audit reports to include auditor recommendations has yet to reach sufficient strength for it to be included as a requirement specified by ISO 9001.
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#22
The following is from ISO 9004:2018:

10.5 Internal audit
Internal audits are an effective tool for determining the levels of conformity of the organization’s management system to its selected criteria. They provide valuable information for understanding, analysing and improving the organization’s performance. Internal audits should assess the implementation, effectiveness and efficiency of the organization’s management systems. This can include auditing against more than one management system standard, as well as addressing specific requirements relating to interested parties, products, services, processes or specific issues.
To be effective, internal audits should be conducted in a consistent manner, by competent people, in accordance with the organization’s audit planning. Audits should be conducted by people who are not involved in the activity being examined, in order to give an independent view on what is being performed.
Internal auditing is an effective tool for identifying problems, nonconformities, risks and opportunities, as well as for monitoring progress on resolving previously identified problems and nonconformities. Internal auditing can also be focused on the identification of good practices and on improvement opportunities.
The outputs of internal audits provide a useful source of information for:
a) addressing problems, nonconformities and risks;
b) identifying opportunities;
c) promoting good practices within the organization;
d) increasing understanding of the interactions between processes.
Internal audit reporting usually contains information on conformity to the given criteria, nonconformities and improvement opportunities. Audit reporting is an essential input for management review. Top management should establish a process for reviewing all internal audit results, in order to identify trends that can require organization-wide corrective actions and opportunities for improvement.
 

John Broomfield

Staff member
Super Moderator
#23
Thanks for the guidelines which, of course, are not requirements.

Every nonconformity reported is an opportunity for improvement.

indeed, the only bad nonconformity is the one that remains unknown.

But internal auditors should be careful not to make the systems they audit depend on them for improvement.
 

Johnnymo62

Haste Makes Waste
#24
I must be real confused again.

I thought the Lead Auditor is the decision maker on what happens with individual internal audit reports. When I was a Lead Auditor, I would review each auditor's findings to decide if the findings were correct and what to do.

Like, initiate corrective actions to the departments that had a valid nonconformance.
Have the auditor correct their findings if the findings were invalid. I had Auditors not find the evidence of conformance...
I would talk to the department heads when OFIs were noticed. Then I would document their decision on the Audit summary and tracker.

It worked for us, then.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#25
Thanks for the guidelines which, of course, are not requirements.
Of course, not. But who is limiting the scope of the answers here to 9001? Internal audits are, historically, the biggest wasted opportunity for organizations to improve their systems. Just like customers audit suppliers, the concept of internal customers auditing internal suppliers should be effected. Nobody better than the downstream process/department knows what the upstream supplier can mess up.

Without a question, competent internal auditors should go beyond compliance verification and delve as well in to risks, opportunities for improvement. Failure to do so would be a waste of their time and knowledge. That's what ISO 9004 (beyond 9001) tries to convey. The problem is: the majority of internal auditors are NOT made competent for the unpopular task.
 

John Broomfield

Staff member
Super Moderator
#26
I must be real confused again.

I thought the Lead Auditor is the decision maker on what happens with individual internal audit reports. When I was a Lead Auditor, I would review each auditor's findings to decide if the findings were correct and what to do.

Like, initiate corrective actions to the departments that had a valid nonconformance.
Have the auditor correct their findings if the findings were invalid. I had Auditors not find the evidence of conformance...
I would talk to the department heads when OFIs were noticed. Then I would document their decision on the Audit summary and tracker.

It worked for us, then.
The lead auditor is obliged to fulfill the audit objective which comes from the audit client. Before the audit the lead auditor advises the audit client what is needed in order to fulfill the audit objective.

Of course this is much less formal for internal audits where there are no contracts or travel expenses.

Even so for internal audits top management (as the audit client) has every right to expect their audit objectives to be fulfilled.

And rarely do we see an audit objective insisting that the auditor makes recommendations as and if necessary.
 

Jim Wynne

Staff member
Admin
#27
The lead auditor is obliged to fulfill the audit objective which comes from the audit client. Before the audit the lead auditor advises the audit client what is needed in order to fulfill the audit objective.

Of course this is much less formal for internal audits where there are no contracts or travel expenses.

Even so for internal audits top management (as the audit client) has every right to expect their audit objectives to be fulfilled.

And rarely do we see an audit objective insisting that the auditor makes recommendations as and if necessary.
Rarer still are audit objectives that follow a course like you're describing.
 

John Broomfield

Staff member
Super Moderator
#28
When your internal auditors write their audit reports, what direction do you provide on OFIs? I'm thinking that tracking something that might never get done is not useful, and in a high pressure environment where all of my auditors are "volunteers" - OFIs never get done unless I drive each of them myself. During external audits I get a lot of verbal OFIs that I find useful, but I'm running into too many OFIs that are really non-conformances.
Should any system evolve to reflect the recommendations of its auditors?

Of course not.

As auditors what are we doing to prevent that?

My audits answered the audit objective. This meant that I avoided issuing OFIs as part of the audit unless specifically instructed to do so in the documented audit objective. Then the record would show what type of audit it was.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#29
The fact that ISO 9001 has not made auditor suggestions mandatory says not enough for this desire to become a requirement.

Generally though, auditee managers like to ask for recommendations because it stops the auditor from auditing.
So if ISO doesn't make something mandatory it means most companies don't want it and we shouldn't do it? :bonk:

Respectfully, this kind of narrow-minded, compliance-focused thinking is too prevalent.
 
Thread starter Similar threads Forum Replies Date
Q How to provide evidence of Strategic Direction (Easy) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
G Lean Kaizen: continuous, step-by-step improvement in the Lean direction Lean in Manufacturing and Service Industries 0
A Supplier Quality Standard vs Senior Management Direction Supplier Quality Assurance and other Supplier Issues 2
I ISO-9001:2015 - direction on New Product Development? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D EMS Management review outputs - Strategic direction of the organization Miscellaneous Environmental Standards and EMS Related Discussions 1
C Direction for Use/ UI for stand alone software Canada Medical Device Regulations 1
S Package Storage Direction in an I.T. Warehouse ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N Corporate direction - External Auditor Influenced by Corporate Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
AnaMariaVR2 A Bold New Direction for Japan's Economy Coffee Break and Water Cooler Discussions 0
Q Manager / Employee - Acting through initiative rather than direction Career and Occupation Discussions 3
E Internal Audit Difficulties - Am I headed in the right direction? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 34
Michael Malis IOM Committee on 510(k) - Ditch It! Are you in agreement with this direction? US Food and Drug Administration (FDA) 3
R Change in Direction - Management decides to Outsource Manufacturing Operations ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q Auditing without Clear Procedural Direction IATF 16949 - Automotive Quality Systems Standard 8
S Quality Initiative 2011 - A new direction? Coffee Break and Water Cooler Discussions 0
N ISO 9001 - Getting started and would love some guidance and direction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Honda: Nap direction in fabrics IATF 16949 - Automotive Quality Systems Standard 6
M GHTF, next-gen MDD...headed in the same direction? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
H Need some direction - I know nothing about ISO 9001 Training - Internal, External, Online and Distance Learning 10
F Developing a Sales procedure - Direction needed Document Control Systems, Procedures, Forms and Templates 11
P RoHS direction / request, including getting product through customs RoHS, REACH, ELV, IMDS and Restricted Substances 1
Q Point me in the Direction of an Industrial Engineering (IE) society in IL or SE WI Lean in Manufacturing and Service Industries 5
C Need Direction on Process Flowchart for our upcoming ISO 9001:2001 audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
J Internal auditing focus - Opinions on "what direction" so to speak Internal Auditing 31
R Pointing in the right direction for TickIT - Software Development Processes Software Quality Assurance 2
J Looking for a training organization that can provide in house DFMEA training FMEA and Control Plans 4
S Can we provide training plan as corrective action for IATF 16949 Non conformity? IATF 16949 - Automotive Quality Systems Standard 9
J Customer VDA Audit - We must provide refresher training? VDA Standards - Germany's Automotive Standards 4
M FDA News Safety Alert – USFDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation Medical Device and FDA Regulations and Standards News 0
J Medical Device Registration in Argentina - Client asks us to provide “European FSC” Other Medical Device Regulations World-Wide 4
M Is it ok to provide a different language upon request? EU Medical Device Regulations 25
N GDP - Having to provide a reason when writing N/A? ISO 13485:2016 - Medical Device Quality Management Systems 1
C How long is an OEM obligated to provide spare parts and repair EU Medical Device Regulations 2
B Is a parent company who provide services to its subsidiary a Supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M How do we document and measure a service we do not provide? IATF 16949 - Automotive Quality Systems Standard 1
J IATF 16949 Cl. 8.4 - Externally provide process not for automotive part IATF 16949 - Automotive Quality Systems Standard 3
S Is it mandatory to provide the results of the validation report in handwriting? ISO 13485:2016 - Medical Device Quality Management Systems 5
R GHS compliance - Are we are required to provide an SDS? Manufacturing and Related Processes 3
A Can someone provide an example of a Product Safety Policy? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
S Can anyone provide an example of Design Validation Protocol and Report? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Can anyone provide me a copy of uncertainty in excel file? Excel .xls Spreadsheet Templates and Tools 4
F How to provide 2 MOPP (Means of Patient Protection) - Heating Rod IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M How to provide Stability Study for micron-precision tool Misc. Quality Assurance and Business Systems Related Topics 2
E Do I hire a Chemist or a non-Chemist and provide training ? ISO 13485:2016 - Medical Device Quality Management Systems 6
V Manager wont take the lead ....Leadership wont provide clarity....what to do? Quality Manager and Management Related Issues 6
A Pls provide some examples of Quality System Basics (QSB) Internal Auditing 3
D How long must we provide service parts to Ford? IATF 16949 - Automotive Quality Systems Standard 7
Q Who can provide a ISO 9001 Lead Auditor QMS training course? Training - Internal, External, Online and Distance Learning 2
V How much Supplier Information do I have to provide to a Customer? APQP and PPAP 6
somashekar Who can provide a WHO GMP certificate in India acceptable to the CDSCO Other Medical Device Regulations World-Wide 6

Similar threads

Top Bottom