Finding against IATF 16949 9.2.2.1 - MGMT. Review did not include a review of the effectiveness of the audits completed.

Vader22

Starting to get Involved
We received a finding since our last management review did not include a review of the effectiveness of the audits completed. Please advise/share how you address the following at your organization.

1.) What criteria do you use to determine the effectiveness of audits completed?

2.) How do you incorporate this into your management review? Ex: Do you make a statement concerning this in your MGMT. Review PowerPoint or other document? Please share examples.
 

Golfman25

Trusted Information Resource
I think a lot will depend on the size of your company and how you do management review. Some metric like audits completed on time or findings found can be reviewed. As well as a breakdown of what processes where audited, etc.
 

Tidge

Trusted Information Resource
I'm reluctant to make any suggestions about "measuring the effectiveness of audits"... to my way of thinking systems are supposed to be effective without having to audit them! I suppose at a bare minimum the audits could be verified to be happening per the appropriate schedule.

I think working the assessments into Management Review is more straightforward: Executive Management should know, at a high level:
  1. What was supposed to have been audited (since the last review)
  2. What was audited (since the last review)
  3. What the results of those audits were.
Presumably management needs to know if enough resources have been devoted to the audits (internal or external). If no negative outcomes happen from the audits, I suppose that Management is at a dead end for this part of their review. If negative aspects are showing up on Corrective Action space (during Management Review) for items that Management thinks perhaps ought to have been uncovered during a past audit... then perhaps more metrics will be added to the audit review portion?
 

Jim Wynne

Leader
Admin
What kind of audit? Please post the entirety of the auditor's NC statement.
It's a reasonably simple thing to (a) review audit results (b) and determine whether or not the audits were effective in achieving the audit objectives. This doesn't have to be at the time of the MR meeting (if there is one); it can happen any time after audits are complete. The review results should be cited in the MR meeting minutes.
 

Steve Prevette

Deming Disciple
Leader
Super Moderator
1.) What criteria do you use to determine the effectiveness of audits completed?

2.) How do you incorporate this into your management review? Ex: Do you make a statement concerning this in your MGMT. Review PowerPoint or other document? Please share examples.
In my experience:

1. All audits and assessmetnts had some form of Lines of Inquiry, so looked to see if they did all the LOI's and if not, did they document why not. Then looked at the report, comparing the text notes to the "grade" for each LOI. If the LOI was graded acceptable did there appear to be formal documentation that supported that. Alternatly, if it was not acceptable, what specific LOI was violated and did that tie back to a "real requirement". We also looked at past audits/assessments of the same topic to see if there were any trends in violations or poor quality of the audit.

2. For assessments, that went into a performance metric that I tracked, and we informed owning management and the person(s) responsible for the assessment. For audits, we documented results in an annual compiled audit of audits.

Cannot provide examples as even if I had kept them after I retired, they would be proprietary information.

We also assessed, graded, and use as a performance metric the effectiveness of the corrective actions on audits and assessments.
 

qusys

Trusted Information Resource
We received a finding since our last management review did not include a review of the effectiveness of the audits completed. Please advise/share how you address the following at your organization.

1.) What criteria do you use to determine the effectiveness of audits completed?

2.) How do you incorporate this into your management review? Ex: Do you make a statement concerning this in your MGMT. Review PowerPoint or other document? Please share examples.
Audit results (internal/external) are an input to a management review. The auditor looks for documented evidences in the management review documentation, such as a summary of the relevant action derived from them ( example: effectiveness of closed actions, number of findings per processes and sections/clauses of quality standard, adherence to the audit program ...). Another example could be the check of KPI's of the audit process during mgmt review. Besides, she/he looks for risks included in the audit program and of there are room to increase audit frequency.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
During Management Review each slide topic has a footer of "Resource provision and acceptance" This is a final discussion captured in the meeting minutes where the management team is asked, "For this output reviewed do we agree it is performing acceptably and no change in provisions are required?" The minutes will capture the responses from each team member. In the end, if there are areas that were not agreed with we open a CAPA and determine what needs to be done, and depending on the severity of feedback, open an investigation on it. Audit assessments are a narrow topic so I use MR to capture all feedback on QMS outputs. We also schedule our internal audit just prior to MR which then is rapidly followed by an external audit
 
Top Bottom