Must a registrar employ a certified lead auditor?

Step Five: Control Key Processes and Widen Preventive Actions

Controlling key processes, including preventive actions

Managers and their process teams make sure processes are under control and effective. The same goes for analyzing records, initiating and taking effective preventive actions. Your system will define who has these responsibilities.

A process or system is considered effective when it meets its objectives. This highlights again the importance of process and system objectives being documented. These objectives are ultimately driven by external requirements (including regulations and contracts) and by internal requirements from managers and other team members.

The process is under control when it can be relied upon to meet its objectives. Nonconforming output (product or service) from a process that meets its objectives means one or more of the following:

  • The process should not have been used for this purpose
  • The objectives are too feeble
  • The process needs to be redesigned

This suggests that the process of setting objectives for key processes is itself a key process. Careful examination of some system standards will confirm this in the form of quality planning (clause 7.1 from ISO 9001) or planning (clause 4.3 from ISO 14001).

Preventive action is widely misunderstood. The world's favorite airline for example, intercepts, collects and analyzes the data flowing to the flight recorder for every flight using a cassette recorder. The cassette is filed by the Captain with the flight records. The data from the cassette are analyzed by the safety team to identify unusual incidents (such as bumps in the runway, abrupt changes of direction, failures of the pilot or co-pilot to respond to air traffic control). The information from analysis of these data is used to invoke preventive action (such as maintain the runway and retrain the flight crew).

Some airlines wait for an accident and then analyze the data from the recovered flight recorder to find out why for corrective action. This graphically explains the weakness of a system misclassifying corrective action as preventive action

Preventive action prevents the occurrence of nonconformities, defects, accidents and pollution. This usually requires the review and analysis of information, planning and investment in equipment, facilities, training and /or new methods. This suggests that the primary responsibility for preventive action remains with executive management unless, of course, the team has been empowered to make such investments.

Keep corrective and preventive action procedures separate and identify which of the key processes are serving preventive action, such as management review, planning, process design, training and investing in new facilities/equipment.

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