My experience has taught me that the documentational foundation of an effective IATF Quality Management System consists of a condensed Quality Manual somewhere between 6 & 8 Processes documented on Turtle Diagrams and somewhere between 25 & 30 Procedures documented on 1-2 page flow charts.
I am also convinced that the implementation of an effective IATF Quality Management System requires employees that are enthusiastically engaged in the system along with strong goals and objectives and healthy data to back them up.
However, no system will ever be all that it can be without a robust Internal Audit Program and comprehensive Management Reviews.
In the course of my career I have consistently observed the following poor habits regarding Internal Auditing:
- Not implementing an overall strategic Internal Audit Program and just performing audits
- Using “reluctant” volunteers with no auditing background to conduct audits
- Rushing through audits due to consistently falling behind the audit schedule
- Quickly conducting a “smoke and mirrors” audit right before the annual registrar audit
- Auditing by just “checking boxes” on a generic vague audit checklist
These same poor habits carry over into the following Management Review issues I have also observed:
- Having a quick sentence or two discussion about each required input to just “get it over with”
- Checking a box for each input on a Management Review Form to just “comply with the standard”
- Wasting time going down rabbit trails by discussing low level operational issues
Since the overall strength of a company’s Quality Management System is directly related to the strength of their Internal Audit Program and Management Reviews, let me share some thoughts learned throughout my career of creating, implementing, and auditing Quality Management Systems.
Let’s start with Management Reviews.
In my opinion, a healthy and effective Management Review (MR) is more of a presentation than a discussion. The point of a Management Review is to have the uninterrupted attention of the company’s Top Management to present information on the overall status of the Quality Management System and to then ask Top Management a few simple questions.
“In response to the information that was just presented to you, what do you think overall?”
“What do you want to do, and what do you want to see changed?”
“What should we focus on next?”
“What should we be worried about?”
“Where do we need to improve, what should we stop doing, what should we start doing?”
Understand this – data drives decisions. Present data for Top Management to make decisions with. It is the perfect chance to present the good, bad, and the ugly of the QMS to the very people who are ultimately responsible for the QMS and have the authority to invest in improvements to the QMS.
Thorough Internal Auditing precedes an effective MR. Too many company audit programs consist of creating an audit schedule and selecting some minimally trained “volunteers” to check boxes on a checklist that asks a few yes or no questions related to the QMS and the standard requirements.
An example I have personally seen was, “Does the company have a Calibration Log?” The auditor asked someone in Quality if they have a Calibration Log and checked the YES box when the answer given was “yes”. The auditor did not investigate any content of the log to determine if the information was current, complete, and accurate.
A good strategically developed Internal Audit Program should identify the scope, objectives, and criteria of each audit, and the audit results should be well documented and accompanied with objective evidence.
Here is a very brief example of a Scope, Objective, and Criteria for an audit:
- Audit the Purchasing Department’s approval of new suppliers
- Determine compliance to the IATF Requirements
- Determine compliance to the company procedure and work instructions
- Determine the overall effectiveness of the approval of new suppliers
- Determine if any corrections are needed
- Determine if any improvements are needed
- Compare the company Supplier Selection & Approval Procedure to IATF 16949 8.4.2
- Compare the company practices to their Supplier On-Boarding Work Instructions
- Compare Supplier Approval Records to the requirements in the company procedure
To document the audit results in the simplest and most effective and comprehensive way possible, I personally use and recommend Nimonik’s Auditing App. Nimonik’s App is by far the most user friendly auditing tool that I have seen and the audit reports it generates are highly praised by every registrar auditor that has audited my Nimonik reports.
Below is the link to an article that discusses how to conduct internal audits such that it positively affects the company’s bottom line.
Best Practices: Internal Quality Audits Based on ISO 9001: 2015
To receive a free analysis of your current Quality Manual email firstname.lastname@example.org
Michael Wolfe is a Standards Implementation Consultant that specializes in creating and implementing simple yet thorough Quality Management Systems that are both audit and user friendly and yield impressive improvement results in a variety of industries to a variety of standards. For more information visit www.mcdae.com.