Posted by John Sixkiller:Does an industry standard exist with respect to warranty and rework costs? I would like to compare our numbers to other manufacturing facilities within the USA.
You have just received certififcation, so I guess the first question is, "are you in compliance with your internal auditing procedures?" Assuming your first surveillance audit is ~6 months after certification where are you in relation to your internal schedule? The internal schedule should be tentative and allow for adjustments as appropriate, but should not be too far off target or an auditor may think it is a low priority and getting inadequate attention. Typically, an auditor will expect all designated items to be audited in a 12 month (calendar or fiscal as you choose) period. For example, if you are scheduled to have completed 17 audtis and performed only 2 or 3, I would expect a noncompliance to be issued. If it is early in your audit cycle you may be a bit behind, but have adequate time to catch up - if you have several audits to go and little time left then you may again be given at least an observation or noncompliance that "you are significantly off schedule and will be jamming to much into to short of a time frame to do the job correctly."
The internal audit program is normally audited at each surveillance visit - so, again, where are you in relation to where you "say" you should be?
Best of luck - remember, the harder you work, the luckier you get.
The standard is very general when it comes to this topic and therefore it can be interpreted a number of ways. The standard states that the organization verify that the quality system is effectively implemented. Some auditors may find a problem if a part of the quality system has not been audited in over a year. Another issue is that you are leaving yourself exposed to a system failure that the auditor may stumble on even if that particular part of the system was not on the agenda.
Personally, I make sure al of our QMS is audited within a year.
Steve Burkert
Director Quality and Training- Haywood Co.
Your statements are a little confusing. You sound if you conducted one big internal audit that lasted six months?
As I understand it, ISO asks you to internally audit your elements "at planned intervals"to be determined defined by your quality system. We set our cycle as 12 months which I believe that if you check your manual that is what your company has done. Your quality manager is well within his rights to audit those areas expected to be audited if he shows that he is following a set schedule or that there is an allowance in your companies procedures to change that schedule as needed. If he is solely auditing them in hopes of passing the surviellance audit, he must also maintain his currently scheduled audits.
Check ISO 9001:2001(E) 8.2.2 to better understand what ISO is requiring and then read your quality manual to see how your system was setup to accomplish this.
It depends on the full definition of “perform internal audits over 12 months.” There is nothing in the ISO standard that requires a company to audit the entire management system. Each company needs to understand their system and where the weaknesses are in that system. Having received a recent certification to ISO 9000 it would be hard to objectively prove the system in place at your company is running so well that it is not necessary to audit the entire system. So as an example, the company I work for also recently received ISO 9000 certification. Our process states we will evaluate the need to audit the various sections of the management system to determine where additional surveillance is required. This does not mean we will audit all sections of our system, but if we cannot objectively prove our system is working then we not be in compliance with our stated auditing objectives. Presenting objective evidence that reduced surveillance is possible is the key.
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wyatt 8/13/2002
You have just received certififcation, so I guess the first question is, "are you in compliance with your internal auditing procedures?" Assuming your first surveillance audit is ~6 months after certification where are you in relation to your internal schedule? The internal schedule should be tentative and allow for adjustments as appropriate, but should not be too far off target or an auditor may think it is a low priority and getting inadequate attention. Typically, an auditor will expect all designated items to be audited in a 12 month (calendar or fiscal as you choose) period. For example, if you are scheduled to have completed 17 audtis and performed only 2 or 3, I would expect a noncompliance to be issued. If it is early in your audit cycle you may be a bit behind, but have adequate time to catch up - if you have several audits to go and little time left then you may again be given at least an observation or noncompliance that "you are significantly off schedule and will be jamming to much into to short of a time frame to do the job correctly."
The internal audit program is normally audited at each surveillance visit - so, again, where are you in relation to where you "say" you should be?
Best of luck - remember, the harder you work, the luckier you get.
burkert9 8/13/2002
The standard is very general when it comes to this topic and therefore it can be interpreted a number of ways. The standard states that the organization verify that the quality system is effectively implemented. Some auditors may find a problem if a part of the quality system has not been audited in over a year. Another issue is that you are leaving yourself exposed to a system failure that the auditor may stumble on even if that particular part of the system was not on the agenda.
Personally, I make sure al of our QMS is audited within a year.
Steve Burkert
Director Quality and Training- Haywood Co.
helicheck 8/13/2002
vick,
Your statements are a little confusing. You sound if you conducted one big internal audit that lasted six months?
As I understand it, ISO asks you to internally audit your elements "at planned intervals"to be determined defined by your quality system. We set our cycle as 12 months which I believe that if you check your manual that is what your company has done. Your quality manager is well within his rights to audit those areas expected to be audited if he shows that he is following a set schedule or that there is an allowance in your companies procedures to change that schedule as needed. If he is solely auditing them in hopes of passing the surviellance audit, he must also maintain his currently scheduled audits.
Check ISO 9001:2001(E) 8.2.2 to better understand what ISO is requiring and then read your quality manual to see how your system was setup to accomplish this.
lmiller 8/13/2002
It depends on the full definition of “perform internal audits over 12 months.” There is nothing in the ISO standard that requires a company to audit the entire management system. Each company needs to understand their system and where the weaknesses are in that system. Having received a recent certification to ISO 9000 it would be hard to objectively prove the system in place at your company is running so well that it is not necessary to audit the entire system. So as an example, the company I work for also recently received ISO 9000 certification. Our process states we will evaluate the need to audit the various sections of the management system to determine where additional surveillance is required. This does not mean we will audit all sections of our system, but if we cannot objectively prove our system is working then we not be in compliance with our stated auditing objectives. Presenting objective evidence that reduced surveillance is possible is the key.