Internal Audit Frequency - Remote Site (a Design Center)

R

robertjmiller0759

#1
Can anyone point me to the rule that defines the frequency of internal audits of a remote site, specifically a 200-person Design Center for a Design Responsible world leader in electronics?


I say it should be at least once every 12 months (gut feel, I know I should have it in writing). One of our clients is saying another consultant advised every 36 months and that the registered company management make that call based on a ‘risk assessment’. If anyone has any concrete guidance on this, it would be much appreciated.


The client is not yet registered to IATF 16949 and hasn't selected a registrar. They are a very large global brand who is now getting some pressure to be registered to IATF 16949 (Been registered to ISO 9001 since 1987; however, while they ARE design responsible, they conveniently ‘excluded’ that from their ISO 9001 registration (!!) with the blessing of their registrar. Clearly this will not be acceptable in the new IATF registration. (Can I assume the registrar would audit the remote site above every 12 months?)


Thanks in advance for any advice.
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Re: Question on Internal Audit Frequency - Remote Site (Design Center)

The only customer specific requirement that I know of, on this subject is the one from Volkswagen which requires "self audits" on a yearly interval.

Short of that, internal audits of remote support sites should always use status, importance, past performance, risk, etc... as inputs into the frequency determination. As the CB will assess the remote site on an annual basis, it would behoove the organization to do the same.
 
R

Roland Kelly

#3
I agree with Sidney.

From IATF Rules 5th Edition

5.5 Supporting activities
Supporting functions on site or remote (e.g., product design, contract review, purchasing, warehouse, etc.) shall be audited as required to support a site but shall be included in the initial stage 2 audit, at least once more during the surveillance audit cycle and at the recertification audit. The only exception is that clients with product design responsibility shall have their design unction(s), on site or remote, audited at least once within each consecutive twelve (12) month period.

When planning the initial stage 2 audit, the remote supporting function shall be audited prior to the site.


Regards,
Roland Kelly
Omnex, Inc.
Menlo Park, CA +1 (650) 208 8803 Cell
 
#4
Can anyone point me to the rule that defines the frequency of internal audits of a remote site, specifically a 200-person Design Center for a Design Responsible world leader in electronics?


I say it should be at least once every 12 months (gut feel, I know I should have it in writing). One of our clients is saying another consultant advised every 36 months and that the registered company management make that call based on a ‘risk assessment’. If anyone has any concrete guidance on this, it would be much appreciated.
There are no "rules" defining the frequency for INTERNAL audits. As has been mentioned, the internal audit program should be based (as IATF states) on importance and in consideration of changes and past audits. So, since the design process is critical in defining "quality" it's unlikely that once a year is going to be sufficient - even if a CB auditor buys into once a year. Take a look at your design process and ask yourself "does it perform to plan?". Do you have problems meeting schedules? Do products need changes after the design is released? Do you have test failures, or the testing delay the release of product? Are your designs "right first time", in basic terms? If not, do some audits to find out why!
 
Thread starter Similar threads Forum Replies Date
P IATF 16949 - Internal Audit Frequency Requirements Internal Auditing 2
F Changing the Frequency of Internal Audits - ISO/TS 16949 Internal Audit Requirements Internal Auditing 5
Q Reducing the Frequency of Audits - Internal Audit Programme 2012 Internal Auditing 13
D Internal Audit Frequency - What does "at Planned Intervals" mean? Internal Auditing 14
P Advice about Internal Audit Frequency Internal Auditing 3
R Ideal Internal Audit Frequency and Scope - ISO 9001 Internal Auditing 6
B Internal audits 3 year plan? Internal audit frequency Internal Auditing 23
GStough Internal Audit Frequency Schedule: Monthly, Quarterly, or Bi-Annually? Internal Auditing 46
G Determining Internal Audit Frequency - ISO 9001 Clause 8.2.2.4 Internal Auditing 15
L Internal Audit Schedule - Frequency of internal audits Internal Auditing 9
B Internal audit checklist Internal Auditing 5
V Internal Audit Software IATF 16949 - Automotive Quality Systems Standard 5
J Internal Audit Schedule IATF Internal Auditing 3
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
P Looking to outsource Internal Audit - MDSAP competent auditor needed Other Medical Device Regulations World-Wide 9
J Outsourced Internal Audit requirements for Aerospace Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
D Number of people to be interviewed during an internal audit? Internal Auditing 10
Q Easy CARs for Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
A Internal audit plan and processes for ISO 14001:2015 ISO 14001:2015 Specific Discussions 3
C API Q1 internal audit report Internal Auditing 3
P Filled in F48/F49 for internal audit ISO 17025:2017 Internal Auditing 2
J Internal audit random sampling methodology Internal Auditing 2
G Organizing internal audit program for an Integrated QHSE Management System Internal Auditing 13
W How do you phrase your internal audit questions? Internal Auditing 3
M IATF - Internal Audit 3 year span Internal Auditing 4
Q ISO 9001-2015 Internal audit finding Internal Auditing 14
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
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 18
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 8
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
salaheddine96 Internal audit planning Internal Auditing 2
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
E MDR internal audit Internal Auditing 1
U Internal Auditor not trained but done Audit for some process Nonconformance and Corrective Action 5
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
F Internal Audit before Pre-Assessment ISO 17025 related Discussions 2
Q Internal audit plan template Internal Auditing 12
L Internal audit during COVID-19 restrictions ISO 13485:2016 - Medical Device Quality Management Systems 5
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
G Addressing Non-Conformances from an Internal Audit that are not product related ISO 13485:2016 - Medical Device Quality Management Systems 11
S Internal audit discrepancy - We missed a few audits that were scheduled Internal Auditing 12

Similar threads

Top Bottom