"On An Annual Basis" - Definition

Wolf.K

Quite Involved in Discussions
Hi folks,

I wonder how to understand "on an annual basis" (or "annually"). In German this is tricky, as it can either mean "once in a year", but also "within 12 month". E.g. 01/2017 to 12/2018 (almost 2 years) are in compliance with "once in a year", but not with "within 12 month". I looked on the web for a definition, but found no answer really satisfying me...

So, if I define "audit frequency" as "annually"/"on an annual basis" - is it within 12 month or within a year (that is, dated 2015, 2016, 2017...)?

:) Wolf
 

Marc

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Leader
My :2cents:

Annual = 12 months = 365 days (except leap year).

If I see "On An Annual Basis", I interpret it to be 12 months maximum (365 days) between each, but can be more frequently.

E.g.: 5 January 2016 to 4 January 2017 = Annually.

and 5 January 2016 to 30 December 2017 would not be in compliance with "On An Annual Basis" because it is more than 365 days.
 

Jean_B

Trusted Information Resource
I presumed changing from "frequency / amount of occurences in a period (regular frequency being spread out over equidistant intervals)" in the older 13485 editions (since this is in the 13485 section) to "interval / defined range of time" in the 2016 edition was meant to clarify this. But maybe it didn't.

I don't find the "annual basis" text in any of the editions, nor the 19011 (since you're talking about audits).
 

Wolf.K

Quite Involved in Discussions
Hi,

Sorry for not providing enough information...

ISO 13485:2016 states

"8.2.4 Internal audit

The organization shall conduct internal audits at planned intervals to determine whether the quality management system: (...)"

So, if I write a SOP and include "annually" as the "planned interval", does it mean "every 12 month at the latest", or "once every year, that is, at least once in 2017, 2018, 2019..."?

:) Wolf
 

Jean_B

Trusted Information Resource
The thing is that neither frequency nor interval have a specific definition under 13485, 9001, 9000 or even their extended glossary.
Definitions resting outside of these are then not only subject to interpretation, but even to relation with the other terminology.

We most commonly think of frequency being composed of occurrences with equal intervals between them, but it is distribution independent in this sense.
In my mind frequency is merely number of occurrences within a specified range (also look up the frequency function in excel to get an idea).

Interval is the space between two points. Defining an interval in my mind then has more to do with distribution between points (most dictionary entries will point to something similar).

How complex you make the interval in the sense of the standard is also a matter of perspective.

You could take for example any of the following:
a) any QMS part will be audited again within a year it was last audited. (Defining the maximum interval), subject to dividing your QMS up into parts, e.g. clauses, as a prerequisite).
If you decided to 'for-cause' audit it ½ a year after your 'regular' audit, you in essence would reset the counter to have the next audit occur no later then 1½ year after the previous 'regular' audit.

b) Regular audit wills occur yearly, with part A being audited in Q1, part B in Q2, etc.
There's always an audit planned for one year after the last regularly planned audit, no matter if amount of covering audits (and thus frequency)went up due to whatever reason.

c) at least one audit will occur each month.
Letting go of parts, you end up with a simplified obligation. This could be risky for ascertaining coverage over the period, or being abused to have 'light' audits count as heavy as full audits for coverage KPI.​

Note that while it does not say documented planned intervals as with the management review, the audit program paragraph "shall" takes care of this. Note also that the audit program does not only require definition, but now also records (unlike the 2012 edition).

So for your terminology:

"Once a year" would be to me: within a year, at least once. Twice a year would for example still be met if it occurred in october and december, no matter if the previous year would have them at january and march. This is because the year defines a calendar period.

"Annually" would be to me a year (12 months, 365 days) from the last occurrence, as annually matches a length of period, but not a specific starting point. Biannually would be: again, half a year from now. (Biennially would be: again, two years from now).
But then this drifts more into dictionary and linguistics then anything else.

tl;dr:
Marc's interpretation is encountered most often and widely accepted. You don't want to have a vocabulary battle with your auditor, you want their help to become or remain as effective as possible. Hogheaven's farm takes the debate out of any of the above, and is the shortcut as a year is not a requirement from the standard (but it might be a requirement from somewhere else).
 

Candi1024

Quite Involved in Discussions
In recent training for the ISO 13485:2016 transition, we were trained that annually is not an interval.
 

Candi1024

Quite Involved in Discussions
He didn't offer a definition. But he stated clearly (and with a firm voice that sticks in my head) said that annual is not an interval. And everyone seemed to nod and agree with him, so I figured I was the only one that didn't know, lol!

Definitions seem to be a big part of this newest revision. That, and turning implicit requirements explicit. He said they tried to clarify many of the definitions.

However, it still doesn't help much in this case. :)
 
This is why we elected to define every term that could be misunderstood in an appendix to our QM. To reference a source - "Interval" is
noun
1.
an intervening period of time:
ie. an interval of 50 years.
2.
a period of temporary cessation; pause:
ie. intervals between the volleys of gunfire.
3.
a space between things, points, limits, etc.; interspace:
ie. an interval of ten feet between posts.
4.

Idioms
at "intervals",

ie. at particular periods of time; now and then:
ie. At intervals, there were formal receptions at the governor's mansion.
ie. at particular places, with gaps in between:
ie. detour signs at intervals along the highway.

None of this defines an interval at anything like a "standard" or "consistent" period of time, in fact, these definitions say just the opposite.

As a smallish company, we all wear many hats, and we schedule internal audits when we can do them. We do not lay out a "plan" in advance, other than that we will try to accomplish all audits on a yearly basis, and the order will be governed by past history and criticality. They may all be done in one week, or they may be spread over the year. And we do not say they WILL all be done, only that we make a yearly completion a goal.
Again, all of this is defined in detail in the appendix, noted as our company's definition of the term.
 
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