If I audit my Processes, Have I audited the Standard?

#11
SteelWoman said:
Where I'm coming from is one of our other divisions was audited and they got dinged for not auditing every ELEMENT of the Standard.
In my "Where's the Shall?" heart, I question the "ding". 8.2.2.1 might apply, but how does the auditor know all "shalls" have not been covered? I would really like to see the actual wording of the nonconformance. Specifically what parts are missing? If the auditor can list some specific things that have fallen through holes in your QMS, then great! If all the auditor can say is that your checklist doesn't match the TS, then though!

But look at 8.2.2.1 closely. I have always recommended "horizontal slice" auditing and "vertical slice" auditing. A system audit will reveal certain things, that are different from a process audit.
 
Elsmar Forum Sponsor
R

RosieA

#12
Hey, Steel,
I figure that after 10 years of being audited by ISO auditors if I don't have all the elements covered in my doc control system, I never will. So I audit to my procedures. I specify the relevant tier twos in the scope of each audit and let the tier twos drill down into the tier threes where necessary.

I did add a yearly audit of the audit system where I have a senior auditor review the audit plan against the standard to be sure we haven't missed any element in our audits.

I've been doing this for three years across 2 registrars and it's been fine. But I'm not TS certified, so there may be some wrinkles there that I don't know.
 
W

WALLACE

#13
I'm just wondering;
Have you experienced and/or accept the existence or allowance of variation when auditing internally or externally?
When the standard says "shall" it has an aura of give me 100% all the time every time. This just doesn't key in with systems thinking at all. The process approach to auditing IMO, is more productive and successfull when an auditor has freedom to assess the variation that may be inherent within all processes. Am I making a valid point or having another one of my brain fa#$s. :lol:
Any thoughts from the group?
Wallace.
 
R

RosieA

#15
HI Wallace,

I think that the judgement issue you're describing has to be built into auditor training. It also may be dependent on the industry that is being audited. Those industries under regulatory control probably need to be stricter in their audit practices than others.

My general direction to my audit team is to look for multiple violations of procedure before writing a finding. If they see one discrepancy out of a number of records, I have instructed them to make the one violation an observation. Something to look into, but not necessarily a finding yet.

That one deviation may be indicative of a process drifting out of control or it can be an anomoly. Before an auditor writes a finding, I'd like to see the deviation repeated.

When a process is following its original design, but is no longer effective, I instruct the auditors to write an improvement note.

Depending on the seriousness of the issue, sometimes I will warn the auditee that if they do not address the observation or improvement note before the next audit, the problem will be escalated to a finding.

When the auditor is undecided about what to do , we talk before the closing meeting.
 
S

SteelWoman

#16
Sam said:
Steel, What you need is to put on the leathers and take a long trip on the Bike. Nothing like it to calm the nerves.
Sam, I ride every day unless it's raining, hot or cold doesn't matter. It's the only thing after a day of working in Quality that keeps me from going home and shopping for guns on the internet!
:lol:
 
#17
SteelWoman said:
Sam, I ride every day unless it's raining, hot or cold doesn't matter. It's the only thing after a day of working in Quality that keeps me from going home and shopping for guns on the internet!
:lol:
Yikes!!! :eek:

Remind me never to argue with you! :lol:
 

Wes Bucey

Quite Involved in Discussions
#18
SteelWoman said:
Sam, I ride every day unless it's raining, hot or cold doesn't matter. It's the only thing after a day of working in Quality that keeps me from going home and shopping for guns on the internet!
:lol:
I have this mental image of Mrs. Emma Peel in tight, stylish leathers, kicking a** and taking names.
 

Attachments

#19
SteelWoman said:
Sam, I ride every day unless it's raining, hot or cold doesn't matter. It's the only thing after a day of working in Quality that keeps me from going home and shopping for guns on the internet!
:lol:
I know exactly what you mean. :agree1: We've had rain all week, but we've had a really mild winter. The coldest temperature was 15 deg. which lasted only two days.
 
Last edited by a moderator:
F

FButcher

#20
Qm

Completed our TS16949 certification audit two weeks ago. One item the auditor recommended was a "Matrix" to show QMS, Process and Product audits had been completed. Help, does anyone have an example?
:confused:
 
Thread starter Similar threads Forum Replies Date
M Inputs on definition of very similar processes for multi site audit sample - IAF MD1 2018 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Can I audit processes I've established but do not implement or maintain? Internal Auditing 6
G Audit of essential QMS processes General Auditing Discussions 11
Gman2 Processes sharing the same nonconformance during an audit General Auditing Discussions 13
D Shall the first Internal Audit cover all the processes of the company? Internal Auditing 17
A Where can I find the NADCAP Audit Criteria for all the processes? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
T Internal Audit - How to define the Importance of Departments and Processes Internal Auditing 8
C How to efficiently audit Suppliers Qualification Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Monitoring of Processes - Audit of a Call Centre ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
H Understanding 8.2.3 M&M of Processes for our Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
E How to perform a DCC Audit (Document Control Processes) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A 3rd Party Audit Finding Not Clear - 4.1 Outsourced Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 36
S Audit on Manufacturing Processes - a) Audit Checklist, and b) Detailed Audit Report Process Audits and Layered Process Audits 13
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
D How to Audit Oracle used for Accounting Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Internal Audit-Customer Related Processes Internal Auditing 2
G Quality Audit on Designers and their Processes and Practices General Auditing Discussions 2
M Internal Audits - Audit Departments or Processes Internal Auditing 13
D Flowcharts of Processes Delayed my Internal Audit Plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
I Can we use layered process audit (LPA) for HR Processes? Process Audits and Layered Process Audits 9
T Records of New Processes for AS9100 - AS 9100 certification audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
J Which is correct: Audit elements of standard or QMS Processes? Internal Auditing 16
Q Internal Audit:Comparing Efficiency of Similar Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D How to audit identical processes? TS 16949 Clause 8.2.2 General Auditing Discussions 2
Q Streamlining incoming audit - 2 separate inspection processes Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
J Does anybody have an audit checklist focused on Manufacturing processes? Manufacturing and Related Processes 8
S TS 16949 ?Audit observation Report? format or form with Input, Output, Processes Document Control Systems, Procedures, Forms and Templates 9
A Process audit - Is it necessary to audit the special processes like plating? Process Audits and Layered Process Audits 2
E Supplier audit checklists for special processes - Plating Process audit Checklist Process Audits and Layered Process Audits 2
Antonio Vieira The importance of some processes... Internal Audit, Management Review, Nonconformance Management Review Meetings and related Processes 3
P Special Processes Audit - Seeking review and comments General Auditing Discussions 7
R Process Audit vs. Element Audit - The auditor focused on 13 different processes. Process Audits and Layered Process Audits 5
CarolX Supplier Audit checklist for special processes Supplier Quality Assurance and other Supplier Issues 3
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
lanley liao How to understand this words that the planning of internal audit shall take into consideration the results of previous audits? Oil and Gas Industry Standards and Regulations 10
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D Supplier audit Medical Device and FDA Regulations and Standards News 2
M Go Live With New ERP System before Recertification Audit General Auditing Discussions 6
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
A Define timeline for Major and Miner Audit finding General Auditing Discussions 4
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 4
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 7
B Remote IATF 16949 audit preparation General Auditing Discussions 10
M AS9100D Registrar pre-audit requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
I Do I need to sign off my annual audit calendar? Internal Auditing 2
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Nice and simple invitation email to an audit kickoff meeting Internal Auditing 1
M IATF 16949 - Audit of Remote Location/Support Site and IT IATF 16949 - Automotive Quality Systems Standard 4
Q IATF audit - Root Cause Analysis results IATF 16949 - Automotive Quality Systems Standard 5

Similar threads

Top Bottom