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Does internal auditing qualify as "monitoring"? Is there any indication anywhere in the standard or when "where applicable" in regard to measurement is forced?
An example I have would be on the Document & Record Control Process. The measure for effectiveness would be all documents in use are controlled documents; all documents were approved prior to use; records controlled per the retention matrix; available at points of use; etc... I don't see this process as being an item where measurement is applicable other than through LPA's and Internal audits.
Additionally, if we are measuring a process (the bid process) and have an established measure (plan to actual costs) and find the process was not effective (our actual doesn't meet the plan) we identify and implement a countermeasure (determine how the item was missed/under bid and use it to update our bid document). Is it necessary to report this out to top managment to meet the requirements of 5.1.1?
Any help that anyone can provide would be appreciated
An example I have would be on the Document & Record Control Process. The measure for effectiveness would be all documents in use are controlled documents; all documents were approved prior to use; records controlled per the retention matrix; available at points of use; etc... I don't see this process as being an item where measurement is applicable other than through LPA's and Internal audits.
Additionally, if we are measuring a process (the bid process) and have an established measure (plan to actual costs) and find the process was not effective (our actual doesn't meet the plan) we identify and implement a countermeasure (determine how the item was missed/under bid and use it to update our bid document). Is it necessary to report this out to top managment to meet the requirements of 5.1.1?
Any help that anyone can provide would be appreciated
The second would meet 5.1.1. The 3rd party cannot tell you how much and how deep your evaluation should be of the process.
When you show the auditor your process map(s) there should be some measurement for that process. You decide your process map and you decide how you measure them. The standard writers strived to not be restrictive when they created TS16949 but unfortunately we tend to look for some type of clear “do or don’t do” in the standard.
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