Quality system design is an essential foundation for successful quality management, but quality systems training – for all employees – maybe the key to successful implementation and maintenance.
For most life science companies, maintaining a quality system has become a way of life. However, it probably isn’t these companies’ quality systems that keep their products and services afloat.
Yes, the manner in which a quality system is designed is duly important but the reality of the situation is that many quality system designs can work equally well in the same (or similar) environments. For example, one life science company may implement a well-known and highly recommended quality system design (ISO 9001 for example) and find great success while another very similar company may implement the same system and fail miserably.
The ability to get company employees to “buy into” a quality system is likely to make a big difference in a “pass or fail” quality system trial even, when a well known quality system design has been implemented. Whether it is change control, CAPA management, internal audits, customer complaints management, document control or deviations management, every company employee needs to know the following regarding his or her company’s quality system:
- What the quality system policies are (at least those that will directly or indirectly affect him or her);
- What the company’s objectives are in relation to the quality system policies, especially those objectives which the employee may be contributing to directly or indirectly;
- What the company’s plans are to achieve those objectives especially those plans that will directly or indirectly affect the employee involved.
Every company should also take steps towards the testing of every employee’s comprehension of policies, objectives and plans related to quality system management. Measuring comprehension does NOT infer that a written exam be administered to employees. Perhaps simple observation from employee supervisors will be sufficient to determine whether one employee has a sufficient grasp of the policies objectives and plans that he or she should be aware of.
According to the FDA’s guidance document: Quality Systems Approach to Pharmaceutical cGMP Regulations, “Policies, objectives, and plans under a modern quality system provide the means by which senior managers articulate their vision of and commitment to quality to all levels of the organization.”1
The FDA guidance also states that “senior management should incorporate a strong commitment to quality into the organizational mission.”2This of course can be accomplished by writing a “commitment to quality statement” in the company’s organizational mission. However, without training, employees are unlikely to care about or even think about quality management ideals and expectations.
To remedy this common dilemma, quality managers need to consider taking the following steps:
- Ask Questions – Quality managers need to take time to talk, and most importantly, ask questions of every employee involved in quality. Well thought out questions regarding quality will at the very least get employees considering the endeavors they are involved in.
- Delegate – More and more, quality is becoming less of a department and more of a group effort. That may seem scary for quality professionals but the reality is that delegation to numerous people (and/or departments) – combined with consistent follow through – always results in better business and better relationships between those who lead and those who follow.
- A Quality Example – If quality managers don’t take quality seriously then it is less likely that other department employees will take the time to contribute to a company “quality cause.”
In short, quality management system may at times seem complex but it’s actually like most managerial responsibilities – primarily a people process.
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