AS/EN 9100 Required Internal Audit Cycles / Interval

A

Angelika

#1
Hello again!

I am just about to prepare the "internal auditing"- procedure for a company that is in the approval phase of both Part 21, Subpart G (Manufacturer), Part 145 (Maintenance) and EN 9100.

For Part 21, Subpart G and Part 145 the competent authority requires that the whole qm-system has to be audited at least once within 12 months.
What are the required audit cycles for 9100? As far as I understand, the standard does not say anything on this.

Would you please share your experience with me?

Thanks a lot and kind regards,
Angelika
 
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harry

Super Moderator
#2
Re: AS/EN 9100 Audit cycles / Interval

Hello again!................... What are the required audit cycles for 9100? As far as I understand, the standard does not say anything on this.................................
Since AS9100 was developed from ISO 9001, it should be reasonable to assume that this interval (cycle) should not exceed 12 calendar months (As in ISO 9001). You may refer to the comparisons from one of the files in our post attachments list - attached herewith (renamed).
 

Attachments

#3
Re: AS/EN 9100 Audit cycles / Interval

Since AS9100 was developed from ISO 9001, it should be reasonable to assume that this interval (cycle) should not exceed 12 calendar months (As in ISO 9001). You may refer to the comparisons from one of the files in our post attachments list - attached herewith (renamed).
But it doesn't say anything in ISO (or AS for that matter) about the audit cycle being/exceeding 12 months...............:mg::frust:

This legend about auditing everything within a certain timeframe was invoked by CB's to ensure that they didn't have to write any 'major' classification findings due to the lack of internal audit coverage of the system (which they then found).

I'd suggest that it is better to focus on the audit program being value-added to management and based on 'status and importance', plus the audit approach being process based - than worrying about conforming to a myth about having everything done once a year........
 

harry

Super Moderator
#4
Re: AS/EN 9100 Audit cycles / Interval

........................ I'd suggest that it is better to focus on the audit program being value-added to management and based on 'status and importance', plus the audit approach being process based - than worrying about conforming to a myth about having everything done once a year........
Your above sentence answers the whole question about the 12 months. Systems like ISO 9001 are formulated for the use of businesses and where you are lost in terms of interpretation, it is important that you should look and interpret it from the business angle.

Countries draw up policies and budgets yearly and it cascades down to businesses and hence quality management systems. Each take the cue from the other to formulate their policies and objectives for the coming year. Since policies and perhaps objectives changes every year, it is perfectly logical that audits be carried out a minimum of once a year to match - it's to match business practice rather than from a CB's angle (I am speaking from a businessman's point of view)

Certainly agree that nobody should worry about all these as long as the audit done adds value to the organization.
 
J

Jeff Frost

#5
Re: AS/EN 9100 Audit cycles / Interval

The actual standard requires that you conduct audits at "planned intervals" and that during the planning the organization must take into considerations the "status and importance of processes and areas" to be audited, as well as the "results of pervious audits".

When the standards talks to "pervious audits results" this is inclusive of 2nd and 3rd party audits of your system (See definition of "audit" in ISO 9000:2005) and the results of your internal audits. Also part of this planning activity must include any contractual requirements from your customers.

The ISO/IAF ISO 9001 Auditing Practices Group and the International Registrars of Certificated Auditors (IRCA) both recommend that organizations should maximize available audit resources based on processes with the highest level of risk of deficiencies or non conformities (circa 2006).

Since you are starting to prepare to audit your system to AS9100 requirements you will need to audit your full quality management system prior to your registration audit. Once this is completed and if you do not have a contractual requirements for a set audit schedule you can then look at how often you need to audit all processes within the organization.

What could change your audit schedule?

- Determination of which process within you organization has the lowest and highest risk of deficiencies or nonconformities.
- Result of external audits (2nd and 3 party)
- Results of internal audits
- Major changes to process within the organization

In any case you should be ready to justify your scheduled intervals based on the review of data you have collected and the risks to the organization. If the data is sound, you do not violate statutory (law) or customer requirements and all process are audited at a planned interval you should not have any problem.
 
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#7
Re: Customer is king.

And as an example of a customer requirement concerning internal audit frequency, check Section 9 of the Boeing Supplemental Quality Assurance Requirements D8-4890.105 document, relevant to suppliers of Boeing rotorcraft, PA.
It's interesting to see that the internal audit requirement is worded almost identically to the QS-9000 requirement from Chrysler. But does it mean doing the whole system once in a year.................?
 
R

Roopak

#8
Re: AS/EN 9100 Audit cycles / Interval

Hi there
we have introduced an internal audit cycle for systems procedures etc matching the regulators surveillance cycle. This means that when the regulators perform their tri-annual full review, all systems have been reviewed during the preceeding three year period. We would, as a small company not have the resources to audit everything annually, which seems excessive and may not meet the business needs. This approach has been applied to local companies with ISO 9001, AS9100 and USFDA GMP (21 CFR pts 210 and 211) and has been found acceptable by auditors. :cool:
 
#9
Re: AS/EN 9100 Audit cycles / Interval

Hi there
we have introduced an internal audit cycle for systems procedures etc matching the regulators surveillance cycle. This means that when the regulators perform their tri-annual full review, all systems have been reviewed during the preceeding three year period. We would, as a small company not have the resources to audit everything annually, which seems excessive and may not meet the business needs. This approach has been applied to local companies with ISO 9001, AS9100 and USFDA GMP (21 CFR pts 210 and 211) and has been found acceptable by auditors. :cool:
IMHO - this is a great example of how not to schedule audits and, therefore, an example of the low expectations of many external auditors when it comes to audit scheduling.

If any organization simply replicates what an external audit schedule does, then they're not addressing the 'status and importantance' of the processes, even if it has a defined frequency. I'd go so far as to say there's a significant risk to customers/management of not discovering that the system isn't functioning as it should until it's too late.

It has little or no bearing on the size of the company how the audit program(me) should be run. Doing large scale, system wide audits may be helpful, but what is more valuable are more frequent smaller (duration), focused, drill downs on selected parts of the system, when things are new, changed or not performing as they should! These don't have to be a drag on resources if planned/done properly.

External auditors may 'buy' what you've done in the past, but I can assure you that's not what the requirement says or intends you to do, and if you look into ISO 9004, there's excellent guidance on what you should consider when running an audit program. Past clients of mine have adopted an approach like this to great effect and little disruption to the business and management see the benefit of avoiding problems, too!
 
R

Roopak

#10
Hi AndyN
we also do the quick drill down audits in response to business issues and perform functional and process based audits. the procedural audit over a surveillance period merely ensures that all procedures are periodically reviewed to ensure system 'creep' does not occur. This is, I maintain a valuable exercise and is not too taxing for companies that do not have an army of auditors or copious resourse.
 
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