I just returned from a plant visit, where I was surprised to find that some important process controls were no longer in place on the production line. How does this sort of thing happen and how do we prevent it?
Implementing an overarching quality system is essential for sustaining best practices across any organization, and the ISO:9001 framework the most commonly followed model for achieving this goal. There are several elements inside the ISO:9001 framework, and one of the most critical is QMS (Quality Management System) audits. When I was a young quality engineer, I viewed QMS audits as outdated practices that added no value. As my responsibilities have grown over the years to include global, multi-plant responsibility, I have come to appreciate the tremendous value of these audits.
What Does a QMS Audit Accomplish?
QMS audits verify that the quality system is being followed, and without these audits, compliance to the quality system is guaranteed to deteriorate over time. This is what happened in the plant I visited. A particular process had been implemented several months prior to my visit that required a great deal of extra effort on the part of the equipment operators. Unfortunately, there were no audit mechanisms in place to ensure that the equipment operators were carrying out their new responsibilities over the long run, and compliance with the new process gradually deteriorated, particularly on the night shift. As a result, the plant produced a great deal of suspect product over time, which cost the business hundreds of thousands of dollars in warranty returns. All of this could have been prevented with a simple routine audit, conducted by the quality team, to ensure that operators across the plant were complying with control plan requirements.
Choose Your Crisis
Businesses have two choices when it comes to the crises they respond to: they can let their customers pick the crisis-of-the-day when poor quality product is shipped, or they can created their own internal crises by auditing compliance to key processes (business processes too) and implementing solid action plans when audit findings uncover major problems with compliance. This latter approach provides far lower quality costs for obvious reasons.
The Keys to Successful QMS Audits
- Have the discipline to create and follow an internal audit calendar – this is the Quality team’s responsibility.
- Make the audits specific and meaningful. Target the critical areas in the business and focus on specific process requirements. General audits, where the auditor randomly selects where to focus, provide very little value.
- This is very important – the management team must react strongly to internal audit results, as if a customer had reported a major quality issue. This type of behavior will ensure that the entire team understands the importance of adhering to the quality system, and that systemic causes behind noncompliance are corrected.
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