Qualified, competent, responsible, authorized and terms derived from them have a number of
potential meanings, some of which are important from a regulatory point of view. Some of
these interact with another contested term, reasonable.
Competence is defined as ‘the ability to achieve desired results by the application of knowledge and skill’
in BS EN ISO 9000 Quality management systems Fundamentals and vocabulary. However, a
competent authority is a body responsible for some legal duty, often safety related, and a
competent person is one trained in identifying hazards, and authorized to promptly eliminate them.
In the EU, a qualified person (QP) is responsible for ensuring the safety of medicines. The QP
will have attained specified academic and professional qualifications, together with several years’
experience working in pharmaceutical manufacturing. (Note that someone equivalent to a QP
may be known as a responsible person (RP) or authorized person (AP) in other jurisdictions).
These role descriptions share common features with formal definitions of ‘qualified’ in other
contexts, requiring a combination of academic and practical training which, arguably, should
add up to competence. However, competence and qualification are not necessarily the same.
OSHA, for example, defines a qualified person as one who, “by possession of a recognized degree, certificate, or professional standing, or who by extensive knowledge, training and experience, has successfully demonstrated his ability to solve or resolve problems relating to the subject matter, the work, or the project.”
OSHA defines competence, on the other hand, as the ability to spot hazards and correct them.
Qualified workers might have more technical expertise than ‘competent’ ones, but they would not
necessarily have expertise in hazard recognition or correction. As well as ‘competent’ and ‘qualified’,
OSHA also define ‘authorized’ or ‘certified’ as different terms with corresponding personal statuses.
Meanwhile, the NPFA defines a qualified person as “one who has demonstrated skills and knowledge
related to the construction and operation of electrical equipment and installations, and has
received safety training to identify and avoid the hazards involved.” NFPA 70E requires that only a
qualified person perform work on or near exposed and energized electrical conductors or circuit
parts, and in the UK, the NEC definition is virtually identical.
So, risk management is a key skill which appears in all definitions except for the EU one, perhaps
surprisingly given its context. Is it right that a person responsible for releasing pharmaceuticals
on the market is probably not an engineer, and may not have the formal training required to
understand the production process?
More broadly, who is a qualified person in engineering? Is an engineer not automatically a qualified
person? Do we require licensing, academic qualification, practical experience, and professional
training validated by examinations to be ‘qualified’, or is a relevant degree sufficient?
Should a qualified engineer not be able to spot hazards and correct them?