2. What do you think is the intent of the following statement in the evidence section of the finding --- “The internal audit records do not show that internal audits are tracking process performance to metrics and meeting specified goals of the process” ---
I suspect the audit records should contain evidence that the audit researched and verified the process performance goals/targets etc and then confirmed that, at the end of the process, the records showed that the goals/targets were being met
I suspect the audit records should contain evidence that the audit researched and verified the process performance goals/targets etc and then confirmed that, at the end of the process, the records showed that the goals/targets were being met
Please help me understand what is wrong with our approach to process auditing described below and/or why a CB would find it unacceptable.
On the day of the audit we determine what product is being manufactured in the process we intend to audit. We determine the process specification in agreed to specifications with the customers, confirm these are consistent with those defined in the control plans and the product specification in our online database.
In this example we start at the input end of the manufacturing process and indentify the specific materials being input to the process. We then move upstream into the purchasing process to determine if these inputs (raw materials) have been verified as meeting our specifications. If we determine that everything is the way it should be we conclude the process is under control (effective). If we find things are different than they should be (the raw materials can not be verified as meeting our specification) we conclude that the process is not under control (ineffective) and create a finding of nonconformity.
In this example we start at the input end of the manufacturing process and indentify the specific materials being input to the process. We then move upstream into the purchasing process to determine if these inputs (raw materials) have been verified as meeting our specifications. If we determine that everything is the way it should be we conclude the process is under control (effective). If we find things are different than they should be (the raw materials can not be verified as meeting our specification) we conclude that the process is not under control (ineffective) and create a finding of nonconformity.
Please help me understand why this audit process does not “monitor process (purchasing) effectiveness”. Why is it important to identify an overall performance metric for this process and assess whether that metric is being met if I already have evidence of process effectiveness? What is the value of verifying or not verifying that the purchasing process objective is being met when this is one of the inputs to management review? Why duplicate the review that should occur during management review? Management review (5.6.2 c.) seems to be a more appropriate place for this assessment as management is in a position to intervene to create change (5.6.3 a.).