AS9100D Risk-Based Internal Audit Schedule

TacitBlue

Involved In Discussions
#1
Hi All,

I am trying to put together a risk-based internal audit schedule for 2023.

My time and I exhaustively went through CAPA history covering the past two years.

We were able to triangulate our problem core processes through looking at trends and prioritized our schedule based on quantity of CAPAs historically received.

Is this approach sufficient or should other information be looked at prior to finalizing our schedule? What else can be done to create a comprehensive and effective internal audit schedule beyond looking at the historical CAPA data?

Thanks
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#3
Hello TacitBlue,

I really appreciate your analyzing your CAPA history in order to factor it into your audit schedule. I would like to see more make this effort.

I don't have a copy of AS9100D in front of me, but if it is consistent with ISO 9001:2015 it will ask for us to
take into consideration the importance pf processes concerned, changes affecting the organization, and the results from previous audits.
I suppose that a portion of your CAPAs come from audits, but they could also come from customer complaints and internally reported issues.

I think it is very important to include organizational changes because they can have unexpected effects on processes they are not directly targeting; the audits could help notice if that is happening.

I hope this helps.
 
#4
”Risk”, if defined as the effect of uncertainty on objectives, has little to do with “CAPA”. You could take the position that there’s little uncertainty with known actions. In fact, “risk”, the way ISO and hence AS discuss it, is a strategic issue and not tactical in nature - which “CAPA” very much is…
 

Sidney Vianna

Post Responsibly
Leader
Admin
#5
We were able to triangulate our problem core processes through looking at trends and prioritized our schedule based on quantity of CAPAs historically received.
Status of processes, functions, departments, etc in terms of past performance of conformance to the system requirements is definitely a valid input into a risk-based internal audit schedule; a chronically “problematic area” should be rewarded with increased oversight for sure. But don’t forget importance. If a program represents 80% of an organization business and failure is not an option, that program (and all the processes involved) could receive a higher level of scrutiny during the internal audits as well. Similarly, programs in early phases of deployment, not mature yet, could also be scheduled for targeted audits. Status, importance & risks, most definitely, are adequate inputs for a well tailored internal audit schedule.
 

DannyK

Trusted Information Resource
#6
Responding to TacitBlue

Check your internal audit procedure.
Do you commit to audit all of your processes within a certain period?
Analyzing your CAPA system for weaknesses is a good approach.
Other criteria to audit a process could be if there were changes to the process, a new process owner or new employees working on the process.
Good luck

Danny
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#7
The word “schedule” is, and never has been, used in the internal audit requirements. The words used are “planned”, “frequency” and are not synonymous with “schedule”. This is, and always has been, “mission creep” from external audits - an expectation of some CB auditors etc. Risk doesn’t conveniently happen to some calendar of events. Its associated with business events. An audit programme should be dynamic to support the needs of the (potential) risks impacting the business and its processes. Planning internal audits effectively involves management, not satisfying an unstated belief the standard requires a schedule
The combined terms planned and frequency do naturally infer that some schedule might reasonably be established. While it's fair to assert that a schedule is not specifically required, we can ask ourselves how this planning is done to incorporate frequency.

My hope is that an audit schedule can be established which takes into consideration the importance pf processes concerned, changes affecting the organization, and the results from previous audits. Schedules can of course be altered based on business needs; this is wholly appropriate and in keeping with the ISO clause. If it turns out that resources need to be allocated according to need, it may even result in a need to push out audits of processes that bear lesser risks and have no actions that would make an audit's scrutiny worthwhile.

The latest versions of the standards have endeavored to bring greater sensibility to management systems. The audit clause is no exception.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#8
My hope is that an audit schedule can be established which takes into consideration the importance pf processes concerned, changes affecting the organization, and the results from previous audits. Schedules can of course be altered based on business needs; this is wholly appropriate and in keeping with the ISO clause.
Spot on, Jen. Below is an excerpt of ISO/TS 9002:2016 concerning this topic:

Screenshot 2022-11-19 180733.png
Some people, claiming to be out-of-box thinkers, believing they have had an epiphany and nobody else sees the light just muddy the waters.
 
#9
The word “schedule” isn’t used in any standard. Those who reference terms which are without a supporting definition, to ensure consistency etc. should be very cautious. We have definitions for a good reason. Oddly, it seems the above description cannot be found in ISO’s own authoritative guidance on auditing, ISO 19011. How strange.
 
Thread starter Similar threads Forum Replies Date
D AS9100D 8.4.2 Note 2 Significant Operational Risk AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R AS9100D Cl. 8.4.2 - Identify Raw Material as a Significant Operational Risk AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Will this fulfill the AS9100D Risk Management Requirement AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
T AS9100D Work Transfer Plan Analysis AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
T Company AS9100D External Audit Preparation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
C AS9100D to CMMI Dev 2.0 Mapping & Comparison Matrix Software Quality Assurance 1
H AS9100D Exclusions, if Not Excluded Is it Automatically Applicable? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
P AS9100D clause 8.6 - Documentation required to show evidence of conformity AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
F Surveillance Audit for AS9100D and new ERP system incorporated Document Control Systems, Procedures, Forms and Templates 4
Q Purchasing Clauses in AS9100D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Quality Specialist AS9100D Approved Supplier List requirements and how to apply Supplier Quality Assurance and other Supplier Issues 11
T Combining 2 companies with separate AS9100D certificates! AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
D AS9100D 8.5.1.3 First Article AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
Stefan Mundt AS9100D Engineering sample purchases - Supplier not approved AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A AS9100D new certification cost?? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Moving from AC7004 to AS9100D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
I RCCA per AS9100D 7.5.2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 22
M Best accreditation body for AS9100D Lead facility auditor? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M AS9100D Registrar pre-audit requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
K AS9100D 8.2.1 Review Requirements for Products and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
A AS9100D - Clause 8.1 Operation - Coating service company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T AS9100D Clause 10.2.1g Supplier Corrective Action for each and every nonconformity? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B AS9100D 7.1.5.2 Calibration or Verification Method using outside cal lab AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T Transition from ISO9001 to AS9100D: O&G to Aerospace AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
H AS9100D clause 8.5.1 f) & 8.5.1 g) - Special Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A AS9100D 8.1.4 Prevention of Counterfeit Parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
B Purchasing AS9100D Standard in Japanese AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Stefan Mundt AS9100D Major nonconformity due to recurrence of a NC during a subsequent CB audit. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B AS9100D Sampling Plan AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A What To Clauses Exclude - AS9100D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
F AS9100D Internal auditing requirements Internal Auditing 11
A AS9100D FAI requirements needed? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
F AS9100D Process Matrix for a small cnc machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
C AS9100D -8.5.1j - Accountability For All Products Tiny Parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Free downloadable AS9100D audit checklist ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
K AS9100D Clause 7.5.2.a) - What is considered to be "documented information"? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T AS9100D - Scope of QMS for New Company - Only Choosing a Function Subset Due to Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
Nicole Desouza AS9100D - Calibration of Dies & Tooling - Plastic Extrusion AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Q What is the difference between AS9100D 9.3.2.f and 9.3.3.a AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
S AS9100D PEAR - Examples for organization's method for determining process results? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
DuncanGibbons Why is 8.4 post-delivery activities before 8.6 release of products and services in AS9100D? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
K AS9100D 8.4.1.1 external providers question - Walmart, Home Depot, our lawn care team. etc. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
W Core Process Metrics AS9100D for Product Planning? Quotes and sales? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
C Taking exception to customer requirements or specifications & AS9100D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
I AS9100D Non-conformance for 10.2.1 b 2 and 10.2.1. b 3 e and f - Corrective Action AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
M AS9100D Competence and Training Records - X-Ray AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P Design exclusion in AS9100D for commercial products AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7

Similar threads

Top Bottom