8.2.2.4 Audit Plans - Can anyone share an example of their Internal Audit Plan?

J

jawatts - 2009

#1
Can anyone share an example of their Internal Audit Plan? Combining system, process, and product audits into one plan is becoming a hard sell for me to the GM.
 
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Marc

Fully vaccinated are you?
Staff member
Admin
#2
What, specifically, is GM asking for or having a problem with?

I think there are some audit plan examples here - Have you browsed the attachments listing?
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
#3
Marc said:
What, specifically, is GM asking for or having a problem with?

I think there are some audit plan examples here - Have you browsed the attachments listing?
Good question, Marc. I, too, was wondering what was so difficult about the sell...except for resources. I know that sometimes the resource requirements for a complete system (like it sounds like may be done here) can be draining as people are pulled away from their normal duties for an extended period of time.

Jawatts, if you scroll down to the bottom of this thread (past the list of people reading it), you'll find links given to some possibly helpful threads.

With regards to the audit plan, you simply need to use some common sense. :) Know the processes at your location and their interaction. Then you need to know how the clauses relate to these processes. And you can start to set up your audit. Knowing about the core documentation will help, too.
 
C

cheahga

#4
TS audit cover all shift work

Hope that anyone of the expect could help me on this:

If I have a group of shift workers, i.e., A, B, C, D rotating at work for 12 hourly basis for 24 hour non-stop manufacturing activities.

For instance,
1st day - 4th day of the first week - A - morning, B - night, C - rest, D - rest
5th day - 7th day of the first week - C - morning, D - night, A - rest, B - rest
and continue

Am I suppose to audit all the groups of the rotating shift covering until the end of the week OR I just cover 24 hour shift work regardless of the group they are working?? :confused:

Please advise.

thanks in advance
 
W

WALLACE

#5
jawatts said:
Can anyone share an example of their Internal Audit Plan? Combining system, process, and product audits into one plan is becoming a hard sell for me to the GM.
What's your product and/or service?
Wallace.
 
Y

YankInOz - 2009

#6
cheahga said:
Am I suppose to audit all the groups of the rotating shift covering until the end of the week OR I just cover 24 hour shift work regardless of the group they are working??
It sounds like you are trying to audit your staff rather than the process? Your audit plan should cover EACH of your processes/sub-processes, as well as certain aspects of the standard. However, if the results from one shift vary greatly from another shift, then I would consider auditing the shift with the poorest results to figure out why there is a variance in results.
 
C

cheahga

#7
YankInOz said:
It sounds like you are trying to audit your staff rather than the process? Your audit plan should cover EACH of your processes/sub-processes, as well as certain aspects of the standard. However, if the results from one shift vary greatly from another shift, then I would consider auditing the shift with the poorest results to figure out why there is a variance in results.
HI YanInQz,

Thanks for your input. My understanding is the same as you. :agree1:

I'm trying to plan an audit based on process approach which is meeting the TS requirement of shift audit and focusing on the process variance.

However, I was told by my in house internal auditor as I'm still new to this co., our CB asked our team to audit all the group of the operators and all shift in 24 hours rotating basis. I personally feel it's overkilling.

Any idea?

Please advise :thanx:
 

antoine.dias

Quite Involved in Discussions
#9
Audit Plans

I don't have a combined audit plan.
I have separate plans for system, product, processaudits.

I have attached one example of systemaudit planning.
I'm sorry it's in Dutch - but you will see what is meant because it is a planning of all system audits for each of the identified processes in the company.


Best regards,

Antoine
 

Attachments

Thread starter Similar threads Forum Replies Date
F Product audit sampling plans IATF 16949 - Automotive Quality Systems Standard 3
M TS 16949 Clause 8.2.2.4 Internal Audit Plans - Requirement Scope? IATF 16949 - Automotive Quality Systems Standard 3
Q Interpretation of 8.2.2.4 Internal Audit Plans in ISO TS 16949 IATF 16949 - Automotive Quality Systems Standard 3
J Developing Plans for Corrective Actions for Audit Non-Conformities ISO 13485:2016 - Medical Device Quality Management Systems 5
H Internal Audit Plan - Seperate audit plans for system, process, and for products IATF 16949 - Automotive Quality Systems Standard 4
ScottK My Birthday Plans for Next Week... PED Module B & D audit Coffee Break and Water Cooler Discussions 9
C Internal Audit Sampling Plans - Determining Internal Audit Sample Size Internal Auditing 45
S TS 16949 Interpretations: 8.2.2.4 Internal Audit Plans Internal Auditing 9
J 8.2.2.4 Internal Audit plans - Need an interpretation Internal Auditing 1
S How to Present Action Plans in Response to Internal Audit Findings? Preventive Action and Continuous Improvement 18
L Internal Audit Plans and Checklists Internal Auditing 6
C ISO 14001 Internal Audit - Opportunity for Improvement ISO 14001:2015 Specific Discussions 2
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
J Stage 2 audit initial cert, few data points ISO 13485:2016 - Medical Device Quality Management Systems 4
S Corrections not allowed during audit ISO 13485:2016 - Medical Device Quality Management Systems 7
P Looking to outsource Internal Audit - MDSAP competent auditor needed Other Medical Device Regulations World-Wide 9
R GFE Audit - Violation? GFE Location Controls AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
D Help Me. Non conformitty in External Audit IATF 16949 - Automotive Quality Systems Standard 13
M How to answer ISO9001:2015 audit finding of old revisions of documents being used? Document Control Systems, Procedures, Forms and Templates 8
B UKRP to what level should you audit Class I Technical Documentation? UK Medical Device Regulations 0
I Audit is tomorrow but I refused to participate Misc. Quality Assurance and Business Systems Related Topics 16
I ISO 17025:2017 / ANAB 3125 - Articulating / Communicating Risks vis-a-vis Audit Findings ISO 17025 related Discussions 2
D Verify Audit Trail of SaaS system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
D Re-labeler - audit the supplier EU Medical Device Regulations 2
J Outsourced Internal Audit requirements for Aerospace Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
A PPAP question for audit APQP and PPAP 16
D Number of people to be interviewed during an internal audit? Internal Auditing 6
B Gamma Quarterly Audit Medical Device and FDA Regulations and Standards News 1
A Anxiety - ISO Re-registration Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 69
Ed Panek Auditor MDR (Presub audit) finding EU Medical Device Regulations 2
Q Easy CARs for Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D Question and advice for a supplier self audit questionnaire ISO 13485:2016 - Medical Device Quality Management Systems 6
S Quarterly Dose Audit Medical Device and FDA Regulations and Standards News 5
H When is a SOC 2 audit necessary? IEC 27001 - Information Security Management Systems (ISMS) 3
J NCR- Failure of contract review process - NADCAP audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
D Special IATF audit of sub-supplier IATF 16949 - Automotive Quality Systems Standard 18
A Internal audit plan and processes for ISO 14001:2015 ISO 14001:2015 Specific Discussions 3
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20
C API Q1 internal audit report Internal Auditing 3
P Filled in F48/F49 for internal audit ISO 17025:2017 Internal Auditing 2
A IRIS audit - Discussion about Special Processes General Auditing Discussions 11
J Internal audit random sampling methodology Internal Auditing 2
D Major NC from last audit not fixed not sure how to fix General Auditing Discussions 10
X Sample SOC2 audit report (or a redacted one) IEC 27001 - Information Security Management Systems (ISMS) 0
D Lead time to schedule an ISO 13485 audit General Auditing Discussions 2
G Organizing internal audit program for an Integrated QHSE Management System Internal Auditing 13
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 3
W How do you phrase your internal audit questions? Internal Auditing 3
Z Steps to take before an MDSAP audit for Canada Canada Medical Device Regulations 2
V Csv, excel format - audit trail file of HPLC system ( Empower, openlab, EZchrom or any other ) Qualification and Validation (including 21 CFR Part 11) 0

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