Ideas for an Ideal Internal Audit Program

S

statman78

#1
I have been tasked with comping up with some ideas for an ideal audit program. Currently I am the only full time auditor in the company. During audits we pull people from various areas to help with the audits. However, often times these people are busy with their own work and are unable to help. I have suggested that we hire another auditor who works with me. Together the two of us would make sure that all audits are done on time according to the published schedule. Furthermore, every week we would visit a particular area of the company development, manufacturing, etc and would audit various processes and documentation. The audit cycle would becoming more preventative rather than just going through a standard audit cycle. I also feel that I would have to get buy in from upper management to support such a task. Each visit to an area could potentially generate CAPAs that could be tied in to the cost of quality metric or potential savings for the organization.

This is just an idea but I would love to here any feedback. Thanks in advance.:thanx::
 
Elsmar Forum Sponsor
J

Jeff Frost

#2
Re: Ideal Audit Program

It sounds good if management will buy into it. Skilled auditors come with a price that sometimes management is unwilling to pay. Two full time auditors will allow you to perform product and process audit.

The goal of the audit program should not be the generation of CAPAs but to give top management data that they can use to run the company and to identify possible improvements to process that conform to internal and external requirements.
 
J

JaneB

#3
Re: Ideal Audit Program

How big is your company? How many people work in it? What kinds of things do you do?

What does your 'standard audit cycle' consist of? What kinds of results are you getting? What kind of feedback do you get from management about the value of the audits?

I like the idea of audit being aimed at improvement, but at first glance two full-time auditors, auditing every week, sounds like a lot of audit unless you are quite large and/or geographically diverse.
 
S

statman78

#4
The company employees about 700 people with location in EU, and Japan. I also manage the CAPA system. Standard audit cycle refers to one functional area audit per the published audit schedule. I have not received any feedback regarding the value of the audits other than during our audit CAPAs saved us from getting additional findings during out certification audit.

We don't have to audit every week but the company is large enough where we can spend some days focusing on a particular area such as operations or reviewing a device history file. The informality of such a process would help and allow for improvement.

Does anyone have any other ideas or suggestions?
 
#5
Apart from the calendar 'hard points' - like those dates where you know the CB is going to be present, or 'predictable' events happen, then internal audits could be scheduled based on a 'pull' system. Ideally (that's what you wanted, right?) the management team should know what situations are affecting their processes for the past 30 days or so. Changes, poor performance to goal, etc should be the triggers to have them ask for an audit to establish if the quality system is being used effectively to control the situation - or not.

The use of a 'push' system of internal audits, in other words auditors turning up to audit something which isn't what management have on their 'radar screen' is why you probably don't get much feedback about the value of audits. As a result, management are unwilling to give up their people to do the audits - which is reflected in their passivity about the audits. They reflect managements' attitudes!

Bottom line - you have to involve management in the scheduling of audits and develop the audit program from there.
 

Randy

Super Moderator
#6
The trying to get "buy-in" or "involvement" of management with the internal audits is as bogus a thought as trying to find 3 wise men in the US Congress.......The audit serves a need of management, it's "managements" property and nobody else's........It clearly says that in 9-14-18-9100-13485 and everything else.

If you have to work to get "buy-in" or "involvement" you're on the down-side of the power curve and will remain so.

It's management that has to mandate the creation of an audit program and provide reason for its existance

It's management that has to supply the resources for an audit program

And it's management that has to use the results of the audit program for decison making

You want the perfect internal audit program? Then use you internal communication process and communicate to management its responsibilities relevant to the management system.........USE THE STANDARD!
 
J

JaneB

#8
The trying to get "buy-in" or "involvement" of management with the internal audits is as bogus a thought as trying to find 3 wise men in the US Congress.......The audit serves a need of management, it's "managements" property and nobody else's........It clearly says that in 9-14-18-9100-13485 and everything else.

If you have to work to get "buy-in" or "involvement" you're on the down-side of the power curve and will remain so.

It's management that has to mandate the creation of an audit program and provide reason for its existance

It's management that has to supply the resources for an audit program

And it's management that has to use the results of the audit program for decison making

You want the perfect internal audit program? Then use you internal communication process and communicate to management its responsibilities relevant to the management system.........USE THE STANDARD!
Randy, I do agree this is what 'should be'. But in some cases management hasn't had any/enough experience with good models and good systems including useful audits, and in consequence may have been turned off to a greater or lesser degree. If all you've seen is bad models, that's what you probably think is par. They may believe (because that's all they've seen) that audit is 'just something you hafta do' that produces a lotta paperwork and little useful info. I'm sure you've seen examples of tedious, detail-heavy auditing of very dubious value.

You know and I know and a whole lot of other good auditors and consultants and quality folks know that's not how it's supposed to be.

I've had various clients who'd had crappo systems - that's a technical term ;) imposed on them, document-heavy, overly bureaucratic, not really attuned to the business and not terribly useful all round, but they did get them 'over the line of certification'. But management had also had 'BECAUSE THE STANDARD SAYS' rammed down their throats all the way as the definitive reason why it 'had to be done this way' (usually not true). And thus they had never had the experience of good audits/good systems.

Where they have, they know the value. Or if they get it from the get-go - eg, a new system - they similarly see the value.

In some cases it took quite a while to get management turned around and seeing that a Standard is just good business sense, and that audits are theirs (management's) and it's up to them to get value out of them. But sometimes they need a bit of help to see that. And having their crappo system streamlined, and sorted, and tuned to align with the business so it really is 'how we do things here' as well as meeting the intent and requirements of the relevant Standard.

C'mon, I know we can all criticise 'management' lots, but let's occasionally cut some of them a bit of slack and give them the benefit of the doubt. :)
 
A

Al Dyer

#9
If Management is not operating in the correct frame of mind by now you will surely have a problem setting up an internal audit program. What worked for me in the past was increasing the audit frequency of the management system as it pertained to usage of metrics derived from audit results. (continuous improvement)

Al...
 
J

JaneB

#10
Okay, that's a largish company, then.

I notice you say that:
Standard audit cycle refers to one functional area audit per the published audit schedule.
I'm wondering if you'd consider focussing on process (not functional area) and following processes across functional lines? I've often found these highly useful areas to look at.

We don't have to audit every week but the company is large enough where we can spend some days focusing on a particular area such as operations or reviewing a device history file. The informality of such a process would help and allow for improvement.
Sounds like a good idea to me that might also generate some useful improvement. Can you present it as something like internal review (vs audit) with a different focus?

Do you have the managers on side, or are they agin it? Because if/once they know they can get useful results (as opposed to being criticised), they could be supplying input on things they'd like reviewed/looked at.
 
Thread starter Similar threads Forum Replies Date
qualprod Ideas to stop bad practices in daily work ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
P Training department ideas and development for automotive supplier Training - Internal, External, Online and Distance Learning 6
C Barcode Labelling - Mistake Proofing Ideas & Systems Manufacturing and Related Processes 2
T Ideas for developing a Supplier Quality Management System, non automotive ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Production approval testing - Alternative ideas for Validation Reliability Analysis - Predictions, Testing and Standards 4
O Inventory control ideas - I have an open stock room with a "sign out" book Manufacturing and Related Processes 9
Ed Panek Ideas to keep quotes for consulting service accurate on not inflated Consultants and Consulting 11
B Practical ideas for information labelling in healthcare environment IEC 27001 - Information Security Management Systems (ISMS) 2
F Ideas for brewery poka-yoke system - Labels that are glued to a bottle Manufacturing and Related Processes 0
D Error proofing ideas sheet metal punches Manufacturing and Related Processes 8
D Ideas for Poka Yoke or Improvement - Aluminum FOD in Assembly Customer Complaints 3
K Looking for Calibrated Tool Shadowboard Substrate Ideas AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J ISO 17025 Guide and Ideas for a New Calibration Business ISO 17025 related Discussions 18
G Process for Product Safety - Ideas for Documenting Process for 4.4.1.2 IATF 16949 - Automotive Quality Systems Standard 3
S New Catchy Quality Policy Ideas Wanted IATF 16949 - Automotive Quality Systems Standard 4
P Need ideas on managing Shelf Life Studies within an organization ISO 13485:2016 - Medical Device Quality Management Systems 1
T Need ideas on Synchronization of Processes Design and Development of Products and Processes 2
D ISO/IEC 17025 Implementation Workshop Ideas ISO 17025 related Discussions 2
B Share ideas to make Management Review more interesting Management Review Meetings and related Processes 4
K Product Ideas for Manufacturing Startup Coffee Break and Water Cooler Discussions 4
Gman2 Scope Ideas? Can our scope contain bullets? Example inside. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Ideas for an Open Source Calibration Database Software Calibration and Metrology Software and Hardware 3
T UK Quality Engineering Courses - Your ideas please Career and Occupation Discussions 3
9 Ideas for reducing Human Error during Order Receipt Quality Manager and Management Related Issues 4
B Starting a small boutique and looking for business ideas Career and Occupation Discussions 8
S Ideas on QA/RA Company Magazine Other US Medical Device Regulations 4
A "Refreshing" a Company Ideas scheme Lean in Manufacturing and Service Industries 8
C Ideas on Implementing Lean and 5S Methods Lean in Manufacturing and Service Industries 6
B Need ideas for a friendly bet - Year-end food drive Coffee Break and Water Cooler Discussions 6
L Working closer and better with Suppliers - Practical ideas to improve? Supplier Quality Assurance and other Supplier Issues 8
AnaMariaVR2 Developing Innovative Ideas for New Companies: free course Training - Internal, External, Online and Distance Learning 0
K Looking for Ideas to Track Customer Requests and PPAP Data Packages APQP and PPAP 4
F Quality Awareness Sessions - Seeking Ideas and Presentation Material Quality Manager and Management Related Issues 4
A Request for Daily Talking Point and Meeting Ideas Misc. Quality Assurance and Business Systems Related Topics 15
A R&D Design Control - Ideas to Improve the Quality of Drawings Design and Development of Products and Processes 7
T Quality Control System Ideas to stream line the PPAP Process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
V Ideas, Measures/Metrics for making Quality Proactive? US Food and Drug Administration (FDA) 2
I Looking for Ideas/Tips for Management Review Meeting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
B Ideas on how to differentiate jobs (AS9100 jobs vs. "commercial" jobs) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T Let's share ideas about an inspection problem.... Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
I Any Ideas To Define The Root Cause of Corrosion Issue? Manufacturing and Related Processes 12
P Scorecard Data Forged - Ideas Please Quality Manager and Management Related Issues 3
Y Ideas of interactive exercises for a Quality Training (ISO 13485) Training - Internal, External, Online and Distance Learning 6
J Keeping Milk for Domestic Consumption Fresh - - Ideas? Coffee Break and Water Cooler Discussions 33
Chennaiite Product Release Risk Assessment - Ideas Wanted Design and Development of Products and Processes 2
A Sustainability 101 Training Ideas and Presentation Materials wanted Sustainability, Green Initiatives and Ecology 2
smryan Seeking Conference Room Name Ideas Coffee Break and Water Cooler Discussions 41
A Seeking Views and Ideas on Procedure related to Project Implementation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T Concept Process FMEA examples and ideas wanted FMEA and Control Plans 1
J Would like to remodel our QA Layout Laboratory - Your ideas appreciated Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9

Similar threads

Top Bottom