Declan Cahill

Consultant

Why Quality Systems fail to deliver

March 09, 2015

I was recently asked to discuss the reasons why Quality Systems fail to deliver their expected performance.  

Based on my experience, I believe the following:

Top Management are very busy people and are responsible for the full remit of the enterprises activity.  Delivering the performance of even a small organization has a multitude of valid distractions, i.e. clients requirements, the need to deliver revenue, operational requirements, the weight of statutory requirements that the enterprise are legally required to comply with. So why do Quality Management Systems fail to get the serious attention of Top Management?

Top Management very often do not see the full advantages of what ISO 9001:2008 and later this year ISO 9001:2015, deliver to the enterprise.  It is often delegated to an internal member to delve into the requirements of the standard. Periodically it can be the prestige of having the first Certificate issued, or more commonly ISO 9001 is seen as a client requirement without which, business cannot be tendered for.  Either way, ISO 9001 is an investment by the enterprise into the understanding of how management and staff all interact to deliver the business. 

Top Management should look at their Return On Investment on a QMS as they do any other investment. Being intimately involved with the construction of the policies, processes and procedures that are required, this will deliver an in depth understanding of what the enterprise actually does and how well or how badly it does it. 

When Top management take over an existing system, they should question whether the system is appropriate to their organization, is it effective and is it delivering a performance for the organisation? Is it a management tool that is being used within the daily lives of the total organisation? Often top management will expect all others to engage with the standard, but not themselves, and this weakens the value of the system. An enterprise can hear this message from the Certification Auditors that are brought in to independently audit the enterprise.  Top Management can also get this message from within its own enterprise, by listening to what staff are saying.  For more complex enterprises, confidential or anonymous feedback can also gauge interaction and views of staff.  Again the enterprise needs to be open to the ‘honest’ feedback it can receive and not be too quick to discount outlier comments.

When the system is working there are a number of key indicators on the health of the ISO 9001 system. The use of Quality Objectives, the use and effectiveness of Internal Audits and the CAPA system as currently defined in ISO 9001.

How closely aligned are your business objectives and the quality objectives? A strong alignment will bring the ISO 9001 system into focus. A lack of alignment will leave the quality system without the management support that it requires.

Internal Audits are excellent improvement vehicles but are not without their own challenges.  They need to be objective, and report non conformities to drive improvement internally.  They can also be costly, disruptive, and often are not sufficiently clear as to whether a process is effective and efficient because those auditing do not fully understand the core process. 

CAPA is an excellent health check indictor of a system. Is there a strong and detailed analysis over time of the CAPAs to demonstrate that recurrences in events leading to CAPAs are common? If yes, management should be asking difficult questions of themselves and their business processes. Care should be taken not to blame individuals where processes have failed, but develop an understanding of what the root cause or causes were and determine what can be done to minimise or eliminate them.

The reasons why Quality systems fail or struggle are in essence all related to the lack of management engagement with the standard.  In a sense previous ISO standards including ISO 9001:2008 lets management off the proverbial hook as it outlines what their ‘Responsibilities’ are in Clause 5.1. As Top management have many responsibilities and it can be viewed by some as a passive action.  According to the latest ISO/DIS ISO 9001:2015, there is a change in wording here. LEADERSHIP is now the new term that we can expect to see.  This is an active description on what is expected of Top Management. There are other substantial changes proposed and enterprises should expect to have a busy second half of 2015 as they prepare for the introduction of the new standard. Also the Acid Indicators of Quality Objective alignment, Internal Audit effectiveness and the recurrence of CAPAs are quality system health check quick indicators that are not used enough.

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