How to conduct internal audits?

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#21
The auditors job is not to 'second guess the direction the company has chosen with its documented system by comparison with the standard! It's too late for that and they will win no friends! It's also not the IAs job, IMHO, to start 're-engineering' the system as developed to find improvements, unless that is the stated purpose and scope of the internal auditor.
So that's why my people have not always rushed up with a bear hug when they see me! :D
 
Elsmar Forum Sponsor
#22
If the purpose of audits isn't to find improvements, aren't they then just paying lip service to the requirement for auditing? I thought that was the driving force behind things like ISO9001 - continual improvement?

Crikey. I've never had such an offended response! More often than not, in my experience, when I've audited areas such as the shop floor, I've found that personnel have suggested improvements in the past (maybe informally) and nothing has changed. If these sorts of things get raised in audits at least it has been formally noted, even if a rigid system doesn't allow a change straight away. I wasn't suggesting that an internal auditor should take on the world and his mother:truce:
Crikey - I like that - haven't heard it since I left the UK!

I'm not offended, just trying to point out - for all those of our community - who may have read it the way I did! I did point out that it's my opinion, not that you're wrong per se!

If personnel suggest improvements but aren't listened to, then there's a bigger problem that management should face and auditors are not going to fix that! It's a cultural change that's needed and that won't come from a lowly internal audit!

Indeed, improvements are supposed to be management led (unless you're really fortunate and are called 'Toyota' or similar). So waiting for audits to improve something is not likely to work - especially since many audits are only done once a year!!

I suppose I have a different view, based on my 25 years of doing this stuff and what I see many companies actually doing (and what people post here) - as you say "Crikey!"
 
Last edited:
Q

qualitymoron

#23
tis true that the only direction change can come is from the top.

Having reread my post I could've worded it better...

Blimey, do you think anyone ever went to a career advisor and they suggested auditing to them?
:bonk:
 
Q

QA_chick

#25
Hi

Wow, what a big question. Just off the cuff, the following questions come to my mind:
1. Are you conducting a compliance audit or an effectiveness audit?
2. How would you pick 6 or 7 'effective' procedures? What indicators/evidence are present to indicate that the procedure is effective - i.e. is it 100% adhered to? Do the outputs support process improvements somewhere else in the business?
3. I would start by looking at the company's core processes - the processes that, if they fail, would send the whole house of cards tumbling down, or the 'must have' processes/procedures mandated by ISO or whatever standard you are auditing to.

Auditing takes a special kind of person. Hope this helps :D
 

Stijloor

Staff member
Super Moderator
#26
<snip>Now I've finished the QM and the manager asked me to pick 6-7 effective procedures and audit them.
What does your Manager mean?

Auditing against a documented procedure?
or
Auditing the procedure (the practice) itself?

Stijloor.
 
G

gooofii

#27
Effective?!?! I don't mean to sound harsh, but if they are effective, why audit them? Why not audit the ineffective ones where the results of said audit can add some value? And are you auditing the procedures or the processes?

.
OK:truce: i might just used the wrong expression. I meant the functional procedures , or that which has a direct affect on our products(SOP, Purchasing, D&D, ...) its not like I will close my eyes and 'pick' some procedures to audit.
 
G

gooofii

#28
  1. Procedure column - What about the process? ISO is about process auditing, not procedure auditing.
  2. With an available column, use that to list the Nonconformance ID Number.
  3. NC Found - is this Yes/No column?
  4. Remedial action - Who completes this? Auditors are not required to provide recommendations for fixing things...we are not the experts or the "do-ers" of the function. Let those responsible for the process determine suitable action.
  5. What about a section for strengths or opportunities for improvement? Don't just highlight the bad. Highlight the good...this way, if other departments read, they may find things to copy into their own processes.
1. yea , auditing the processes for each procedure. I thought the procedure name will be in the procedure column and if any NonCons found in the ''Process'' so tht is written in the noncons column.

3. ID no. is that for each Noncon found in each procedure, or you mean like an ID for the whole auditing process.

4. well, actually i meant ''if a NonCon found, write it. if not , just leave empty.''

5. so at least I should suggest some corrective actions, or like give a cution that there should be a corrective action to be done here....?

6. Yea! I will do that, it could be kind of motivation aswell and give us self confidence

as I said, I know the report is quite generic, thats why i proposed it hereso I could find better ideas.
There is a wonderful requirement about competency. By what criteria does your organization say you are competent to audit? I am not saying you are not competent...simply wish to know what the requirements are for someone to be considered a competent auditor within your organization.
well, I hold an eng managment BSC and a Mech.& Mfg MSc plus i have done another project for them before this one and they approved it, so may be thats why they are asking me to do that project . I dont think they have special requirements for auditor, because simply they dont have a quality Dept. its only the GM is doing many quality jobs, and now its me:mg:, even though i am just there as a temporary job until i finish this project:(

I know I am a fresh graduate!, so I might not have the proper practical work skills, but i know aswell that i might have little information and knowledge tht can help me doing wht i didnt do

Thx Roxana for your critique, i do appreciate tht and am waiting for more ideas!
 
G

gooofii

#29
While you are learning how to perform an internal audit of your own processes and procedures, here is the best tip that I have from the experience of having to do it.

Back up and flow out your processes in flow chart format in detail.
.
YEa, thats exactly what I have done while i was writing the QM, I was flow charting the processes of each procedure some of them i done it my self, and others like Andy said took it from the mouth of the horse!
 
G

gooofii

#30
Are you auditing to a particualr standard? For example TS16949 underlines the importance of customer requirements AS WELL as those of the standard. ISO9001 looks like it's heading that way too with it's latest revamp.
yea its according to the BSI ISO9001
 
Thread starter Similar threads Forum Replies Date
J ISO 9001:2008 - Can I still conduct Internal Audits in my company? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R How do I conduct my API Q1, ISO compliant internal audits? Internal Auditing 1
C When is the Best Time to Conduct Internal Audits Internal Auditing 22
Sidney Vianna Can CB's (certification bodies) conduct internal and 2nd party audits? Registrars and Notified Bodies 12
A Does anyone conduct opening & closing meetings for their internal audits? Internal Auditing 19
J Can I conduct Internal Audit for combined ISO 9001, ISO 13485 and ISO 14001? Internal Auditing 37
P Can internal ISO 17025 Auditor conduct ISO 9001 Audit ISO 17025 related Discussions 7
Q Tips on how to conduct a good Internal Audit Opening Meeting Internal Auditing 19
J How to Write the Planned Interval to Conduct Internal Audit, Management Review, etc.. ISO 13485:2016 - Medical Device Quality Management Systems 3
V How many years of experience is needed to conduct the internal audit in my company? General Auditing Discussions 4
A Do we have to conduct tests during internal audit of ISO 17025:2005? ISO 17025 related Discussions 8
M How to conduct the first ISO 9001:2000 Internal Audit Internal Auditing 11
E To conduct ISO 17025 Internal Audit - Auditor Requirements ISO 17025 related Discussions 10
J Internal auditor conduct, unbecoming an auditor... General Auditing Discussions 19
D How to Conduct a TS 16949 Internal Audit - Can I Use a Check List? Internal Auditing 10
M Knowledge of test methods in order to conduct an internal audit to ISO 17025? ISO 17025 related Discussions 3
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
M Informational US FDA Draft Guidance – Patient Engagement in Design and Conduct of Medical Device Clinical Investigations Medical Device and FDA Regulations and Standards News 0
B Is it necessary to conduct product audit of entire product which is manufactured in the company as per IATF IATF 16949 - Automotive Quality Systems Standard 4
C How frequent to conduct Clinical / Performance Evaluation? CE Marking (Conformité Européene) / CB Scheme 4
S Script of R software to conduct Nested GRR for Destructive Testing Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
S CMDCAS ISO13485 - Bilateral agreement with SAI global to conduct Certification Audits ISO 13485:2016 - Medical Device Quality Management Systems 7
S Conduct Customer Satisfaction Survey for every submitted Bid? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T Conduct a fractional factorial 2^13-5 experiment with Minitab Using Minitab Software 4
M Help me understand how to conduct a Chi Square Test Statistical Analysis Tools, Techniques and SPC 3
N How do I conduct Management Review Meetings? Management Review Meetings and related Processes 34
R Can our Supplier's Quality Mgr. conduct Supplier Audit on behalf of manufacturer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F Tips, Guidelines and Checklist to conduct Audit of Supplier & Subcontractor Document Control Systems, Procedures, Forms and Templates 5
L How to conduct a Quality Audit based on ASME BPVC VIII-1 requirements Various Other Specifications, Standards, and related Requirements 4
Y FDA - Does anyone have conduct the validation on GR&R worksheet before? Qualification and Validation (including 21 CFR Part 11) 7
I Code of Ethics and Conduct wanted Document Control Systems, Procedures, Forms and Templates 3
D How to conduct a Gage R&R on DC Tools to Torque Bolts Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
G How to conduct a Toy Recall (College Question) Customer and Company Specific Requirements 2
N How do I conduct Risk Management for my company? ISO 13485:2016 - Medical Device Quality Management Systems 7
K How to conduct a QCC project Misc. Quality Assurance and Business Systems Related Topics 2
N Tyvek Pouch Seal - Pressure needed to conduct Vacuum Seal Leak test? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R How to conduct the Threshold Test of Mobile Equipment specified in 3rd edition? IEC 60601 - Medical Electrical Equipment Safety Standards Series 35
S How to conduct Capability Analysis for this data? Statistical Analysis Tools, Techniques and SPC 12
K Can auditors freely conduct confidential interviews, or consent is necessary? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
P How to conduct ILCP (inter-laboratory comparison programme) to get ISO 17025 ISO 17025 related Discussions 3
M Do we need to conduct Vendor (Supplier) Evaluation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
K When, whom, how to conduct hazard analysis of PRP?s, OPRP?s and CCP?s? Food Safety - ISO 22000, HACCP (21 CFR 120) 1
S Can a suspended CB still conduct Surveillance Audits? Registrars and Notified Bodies 4
J My mentors insist I use hotel's employee manuals and codes of conduct for my... Service Industry Specific Topics 3
somashekar Sustainability audit per EICC Supplier Code of Conduct Sustainability, Green Initiatives and Ecology 14
Marc Apple Enforces "Supplier Code of Conduct" After Child Labor Discovery After Work and Weekend Discussion Topics 13
B How to Conduct a Review of Customer Order (Contract Review)? Contract Review Process 5
M ISO 17025 Audit check list to conduct horizontal and vertical audits ISO 17025 related Discussions 10
D How to practically-conduct, post production phase ISO 13485:2016 - Medical Device Quality Management Systems 1
S Multilevel Design in Minitab to conduct a DOE - 4 factors and each has 5 levels Design and Development of Products and Processes 4

Similar threads

Top Bottom