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Employee Competence: How Does It Matter?


The last thing any healthcare manufacturer would like to receive from the US FDA is a warning letter stating a non-compliance issue. Manufacturers generally take a lot of effort in complying with the Good Manufacturing Practices (GMP) or the Good Laboratory Practices (GLP) but there is always a possibility of missing out on important regulatory aspects inadvertently. One such aspect is meeting the compliance requirements with regards to the workforce competence. The below observation is a classic example of shortcomings in the Competence of a workforce. 

“Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a)).”
-US FDA citation received by Apollo Care in the year 2019

It is clear from the above example that the regulatory body is not looking for mere Qualification of the workforce but it is looking for training and experience in relevant functions. This can be more precisely defined by a term ‘Competence’ which refers to the relevance and frequency with which a skill is practiced. It also refers to the dexterousness with which skill is practiced. In short, Competence means the ability to do something successfully or efficiently. That is why, several regulations and certification bodies use competence as an indirect measure of ability to deliver high quality products and services consistently.

ISO 9001:2015

The compliance of ISO 9001:2015 is centred around the famous mantra of “Do what you say, and say what you do”. Prima facie it sounds very simple, however in practice the service or product providers inadvertently  make overstatements about the actions, features and quality to the potential customers. ISO 9001 tries to keep a counter check on these overstatements by ensuring that  the person(s) involved in doing the work have necessary Competence to plan, do, check and act on the deliverables assigned to them.The purpose is to ensure that the person(s) know what is expected from them and also have ability to deliver what the organization promises to its customers.

The section 7.2 of ISO 9001:2015(E) Standard requires the organization to:

a) determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system;

b) ensure that these persons are competent on the basis of appropriate education, training, or experience;

c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken.

21 CFR 211.25

The Code of Federal Regulations is the Bible of every healthcare manufacturer be it Drug Manufacturer, Drug Product Manufacturer Or a Biomedical Device Manufacturer. The Federal Regulation also ensures to have a check on the competence level of the workforce engaged in manufacturing of the healthcare products. The section 211.25(a) of Code of Federal Regulations also states that:

a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.

c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.

The US FDA has been actively citing observations related to competence in its several Audits. The trend of number of such citations under section 211.25(a) are as shown in below chart:

A more detailed analysis of citations in the year 2018 mentioned in this article. The summary of the citations is graphically presented below chart:


Health and Safety

Competence is not only an important indicator of the ability of a manufacturer to deliver quality products and services but also a major of the ‘Health and Safety’ awareness with which the manufacturer will be able to deliver the products and service.

Customer Trust

Another reason why Competence matters is that it helps tremendously in earning the Customer Trust. There is hardly any business which can sustain without loyal customers who really trust the products of the manufacturer or the services of the provider. This is because of the simple fact that a competent workforce helps the organization in achieving the organizational goals more efficiently.


Competence is a highly valuable metric of the workforce of any organization which measures the ability to fulfill the promises made to its Regulators (for meeting the Quality standards), to its own workforce (for ensuring Health and Safety while on the job) and lastly to its customers (for ensuring a satisfactory experience). It is therefore very rightly said by George S. Patton Jr. that Success demands a high level of logistical and organizational competence.”

Are you also mindful of your organization’s competence? If you are then, you must check our eqms solution (Cloud based Quality Management Software) QualityKick Competences Module which keeps a live track of competence record of the workforce. We are always happy to share our expertise, hence please feel free to write to us for scheduling a free demo.

The requirements of Life Sciences companies (including in the pharma and medical device space) inevitably change over time. Sometimes, a change is due to regulatory requirements; sometimes, customer needs change. Keep reading if you want to...