View Full Version : Determining Internal Audit Frequency - ISO 9001 Clause 8.2.2.4
gromit 16th January 2007, 05:00 PM Hi,
I am a little unsure how to interpret the requirement for the frequency of audits as required by TS16949 clause 8.2.2.4.
It indicates that an Annual Plan is required and all processes, activities and shifts are scheduled in accordance with the plan.
It may seem obvious that they have to be covered within the annual plan however the I am suspicious of the wording in the standard.
Any help would be appreciated.
Sidney Vianna 16th January 2007, 05:24 PM Hi,
I am a little unsure how to interpret the requirement for the frequency of audits as required by TS16949 clause 8.2.2.4.
It indicates that an Annual Plan is required and all processes, activities and shifts are scheduled in accordance with the plan.
It may seem obvious that they have to be covered within the annual plan however the I am suspicious of the wording in the standard.
Any help would be appreciated.Looks like this is your first post. Welcome to the Cove.
You did, however, mixed up ISO 9001 and TS-16949. There is no 8.2.2.4 in ISO 9001. You are reading TS. And, indeed, TS requires an annual audit plan.
fuzzy 16th January 2007, 05:55 PM Hi,
I am a little unsure how to interpret the requirement for the frequency of audits as required by TS16949 clause 8.2.2.4.
It indicates that an Annual Plan is required and all processes, activities and shifts are scheduled in accordance with the plan.
It may seem obvious that they have to be covered within the annual plan however the I am suspicious of the wording in the standard.
Any help would be appreciated.
Welcome to the Cove! While this may seem to be a trick requirement:notme: , I find that we often think only of the minimum, hence the standard just requires your plan to show the frequency (unspecified). For me under an ISO plan, I choose to audit certain processes more than once annually, based on previous audit findings in that process or clause. Throw in the TS mention of shifts, and this complicates the schedule; must be why they call it a plan:confused:
AndyN 16th January 2007, 07:09 PM I'd suggest that you take a look at ISO 9004:2000. It makes interesting reading and, therefore, an opportunity to deal with scheduling audits in a flexible manner. It is quite usual to have a whole calender of audits, say 1/month. Certainly, there are some items of the quality system which should be audited around scheduled events. For example, if you know when a registrar auditor is going to be visiting, then it makes sense to perform an audit (just) prior to that visit. Like cleaning house before family come to stay!!
In most other respects, your audit scheduling should be based on 'status and importance' of the activity or process. There have been other posts here regarding this, but in a nutshell, it could mean using audits to look at processes which are 1) performing under expectations (of customer or the business) and 2) new situations, such as new customers/requirements, new suppliers, new processes, equipment etc.
New = risky, generally speaking.
The aim of the audit is to let management know what the status of the process is, during this risky time. Management is likely to appreciate the results of the audit much more, than if there is a 'random' reason for the internal audit being scheduled.
So, although the TS requirement sounds like you need to have all this planned out in advance, I've had success in choosing a frequency of 'monthly' and defining the 'scope' and 'criteria' of the audit 30 days before doing the audit, based on status and importance, and of course any previous audit findings........
Andy
Beiquan 15th February 2007, 10:25 PM I always use this method to define audit frequency:
Your comments would be appreciated.
AndyN 16th February 2007, 12:07 AM I always use this method to define audit frequency:
Your comments would be appreciated.
It's an interesting idea. I think it may make setting a frequency too complicated and doesn't take into consideration other factors which might influence the decision to perform an audit.
As mentioned in my previous post, when something is changed or it is new, then it's a good opportunity to use the audit to discover how the management system is performing. My suggestion is that a frequency of (say) a month is selected, and then based on various factors, the focus of the audit is chosen during the days/weeks before the next audit is scheduled. You can also perform more, but at least you'll have a minimum frequency of audits to prevent being writen an NC by a registrar.
Instead of using a 'grading' system, ask your management team what they would select to audit. That's almost what it says in ISO 9004..........
Andy
brahmaiah 5th May 2009, 08:21 AM Dear every body,
When you are on a job of maintaining ISO9001 OR TS16949 OR ISO14001 OR for that matter any other standard system,donot mix up requirement of one standard with another.This happens often when you deal with
ISO 9001and TS16949.
ISO 9004 is a very good standard. But my advise to all is not to read it more than once in their lifetime.Because you tend to mix up 9004 requirements with other living systems.ISO 9004 is a perfect system but impossible to executive in your bussiness and still make profits.
some of the obsolete requirements of good old iso9000-1974 or is it 1984 are still haunting me during carrying out an audit
Forgive me if I sound imperfect!
Good luck!
V.J.Brahmaiah:agree:
Jennifer Kirley 5th May 2009, 09:27 AM I always use this method to define audit frequency:
Your comments would be appreciated.This is a sound method for starters, but I wouldn't audit a process more than once per year unless there was a problem with it. Some processes can be audited more than one year apart.
Speaking of problems, I will add to the schedule an audit with a process that has undergone work recently, especially if it had a significant corrective action. So, per this theory (time frames are largely your choice within the registrar's requirement) a process that would have skipped a year might be audited once per year until satisfied it is stable.
Voodoo Queen 5th May 2009, 10:13 AM Hi,
I am a little unsure how to interpret the requirement for the frequency of audits as required by TS16949 clause 8.2.2.4.
It indicates that an Annual Plan is required and all processes, activities and shifts are scheduled in accordance with the plan.
It may seem obvious that they have to be covered within the annual plan however the I am suspicious of the wording in the standard.
Any help would be appreciated.
The entire system must be audited each year. I agree with AndyN's approach, although I prefer a quarterly schedule. If I find a major discrepancy I'll return to that area with my next go-around.
AndyN 5th May 2009, 11:12 AM The entire system must be audited each year. I agree with AndyN's approach, although I prefer a quarterly schedule. If I find a major discrepancy I'll return to that area with my next go-around.
Thanks for the comment, but where do you find that you have to do the whole system each year? Does your CB require this?
Speaking of problems, I will add to the schedule an audit with a process that has undergone work recently, especially if it had a significant corrective action. So, per this theory (time frames are largely your choice within the registrar's requirement) a process that would have skipped a year might be audited once per year until satisfied it is stable.
I think this is real important. That is why the standard refers to "status" of processes. I tell folks to look at the process for risks. Any significant change in a process increases its risk. Of course, high scrap rates, or product returns are also reasons to audit more frequently. Too many times we schedule audits based on a calendar, rather than how often it really needs to be audited.
Voodoo Queen 5th May 2009, 12:10 PM The entire system must be audited each year. I agree with AndyN's approach, although I prefer a quarterly schedule. If I find a major discrepancy I'll return to that area with my next go-around.
I thought I remembered learning it in RABQSA ISO 9001:2008 auditor training (a few of us went through it to "spiff-up" our internal audits) - I could be mistaken. In any case, that is what we follow (we fall under ISO/IEC 17025, anyway, and a yearly audit of the whole system IS required by that standard). It may sound excessive, but I look at it this way: The more rigorous the internal audit the less the 3rd party auditor should find (in theory).
AndyN 5th May 2009, 12:44 PM I think this is real important. That is why the standard refers to "status" of processes. I tell folks to look at the process for risks. Any significant change in a process increases its risk. Of course, high scrap rates, or product returns are also reasons to audit more frequently. Too many times we schedule audits based on a calendar, rather than how often it really needs to be audited.
THANK YOU DAVE (yes I shouted it!)
Too many times this important aspect is totally over looked! Audits can and should be proactive, not simply looking over a shoulder at past audit reports/non-conformities. Make this the 'scope' of an audit, tell the auditors to go see if the change is under control.........
Sidney Vianna 5th May 2009, 01:12 PM I tell folks to look at the process for risks. Any significant change in a process increases its risk. Risk-based audit scheduling! What a concept. I wonder if a CB has something like this...:tg:
Jennifer Kirley 5th May 2009, 01:38 PM I thought I remembered learning it in RABQSA ISO 9001:2008 auditor training (a few of us went through it to "spiff-up" our internal audits) - I could be mistaken. In any case, that is what we follow (we fall under ISO/IEC 17025, anyway, and a yearly audit of the whole system IS required by that standard). It may sound excessive, but I look at it this way: The more rigorous the internal audit the less the 3rd party auditor should find (in theory).We do NOT audit our entire system each year. We run on a three year cycle. Some processes get audited each year (could even be audited an extra time if needed) others every other year, and some every third year - depending on the criticality etc.
We have successfully argued with a TS16949 registrar who tried to tell us each process had to be audited on each shift in each year. NO. We looked at the standard together and he begrudgingly agreed that all we were REQUIRED to do was every manufacturing shift audited each year.
The 17025 bit about one year is a NOTE (at the end of 4.14.1) and as such, is guidance. It also says "should normally" which really clinches the fact it is not a requirement to audit the entire system each year.
AndyN 5th May 2009, 01:56 PM Risk-based audit scheduling! What a concept. I wonder if a CB has something like this...:tg:
Indeed, Sidney! Why, even the first CB I worked - for back in those halcyon days - performed their surveillance audits to a risk based plan........it's not that new to some of us! Sadly, many of the CB 'late-comers' to the world of registration only do the minimum they can get away with!
|
|