#1
Hello all!
I have recently participated in my re-certification audit for API Q1 9th edition. The following was first deemed an Observation then later upgraded to a minor NC. The finding is listed below. Keep in mind that we have identified 22 separate processes that need to be audited annually. The corporate training process was audited but in a 15-month time frame instead of a 12-month time frame(i.e Jan-17 initial audit, Apr-18 next audit). I feel I should challenge this but don't really have much to stand on considering we did not meet the standard verbatim. The problem that I am having is that this allows for no changes in frequency or flexibility of the audit schedule in my case to move audits around based on need or other. I realize that if you read the standard it clearly outlines the requirements but this allows no flexibility in the schedule especially when your organization has identified and has this amount of processes to be audited. Can anyone help on how I should answer this finding?

Requirement - MS StandardAPI Spec Q1 9th Ed

Clause 6.2.2.1 (Identify Criteria, Scope, Etc.)

DescriptionThe organization shall identify the audit criteria, scope, frequency, and methods to ensure that all processes of the quality management system claiming conformity to the requirements of this specification are audited at least every 12 months.

Objective Evidence: All areas were audited within the 12-month timeframe with the exception of Corporate Training that was performed at a 15-month interval. The facility needs to ensure that all audit areas be held to the 12-month requirement.

Nonconformance/Concern DescriptionOne area of the QMS was outside of the 12-month requirement for the performance of internal audits.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
The problem that I am having is that this allows for no changes in frequency or flexibility of the audit schedule in my case to move audits around based on need or other. I realize that if you read the standard it clearly outlines the requirements but this allows no flexibility in the schedule especially when your organization has identified and has this amount of processes to be audited. Can anyone help on how I should answer this finding?
Not sure if I am following your logic here. The API Q1 Spec calls for a MAXIMUM interval of 12 months. If you deem (and you probably should) that some critical and/or low performing processes should be audited at higher frequency, the standard does not prohibit that.
 

Eredhel

QA Manager
Trusted
#3
Are you asking if you can go longer? The language is pretty clear, "...ensure that all processes of the quality management system claiming conformity to the requirements of this specification are audited at least every 12 months." I may be misunderstanding what you're asking.
 
#4
API does not allow for an increase to the 12 month interval.

API has issued an interpretation that performing the audit the same month every year meets the 12 month requirement (for example, you can do March 11 one year and March 18 the next year), so it is not a precise 365 day requirement. However, some auditors are not aware of this interpretation and will still issue findings if you exceed 365 days, but you should win on appeal if you do it the same month as the previous year. You can find the interpretations at: http://mycommittees.api.org/standards/techinterp/mspecs/Shared Documents/Q1.pdf

API will require you to respond with a full root cause (Why did you think a 15 month interval was acceptable when the standard states 12 month maximum?), correction (audit immediately if it has been more than 12 months since any process was audited and/or change the audit schedule if any scheduled audits exceed the 12 month requirement), and corrective action (update your procedure to clarify the 12 month requirement; train the person responsible for scheduling audits on the 12 month requirement; provide additional audit resources if required).
 
#5
Thank you all for the answers. I guess my biggest issue that I am having is adjusting to the new requirement in API Q1 as ISO states annually (calendar year my take on it). So this requirement has caught me a little off guard as I am fairly new to the API specification.
 

Eredhel

QA Manager
Trusted
#6
No doubt. ISO and AS will tell us to do something at planned intervals where API will say do it in this time frame and have more documented procedures. Fun stuff!
 
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Eredhel

QA Manager
Trusted
#7
Thank you all for the answers. I guess my biggest issue that I am having is adjusting to the new requirement in API Q1 as ISO states annually (calendar year my take on it). So this requirement has caught me a little off guard as I am fairly new to the API specification.
Btw what part of ISO do you mean on "annually", are you talking about ISO 9001?
 

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