Employee Training Tips for a GMP Compliant Workforce

By ETQ on February 6, 2018

Is your employee training program proactive, looking forward and evolving to incorporate lessons learned? Or is it reactive, only changing after problems occur? A proactive approach to employee training is the foundation to Good Manufacturing Practice (GMP) compliance. By creating a comprehensive, standardized program and keeping an eye out for common mistakes, companies can foster a proactive quality culture that prevents problems at their source.

Training Pitfalls To Avoid

One way to proactively avoid problems and create a GMP-compliant workforce is through a consistent and ongoing approach to training. This approach can help companies avoid common training-related pitfalls that routinely result in citations. Training-related mistakes that lead to citations often result from:

  • Lack of adequate training, education and experience required to perform assigned functions.
  • Not training employees on operations, standard operating procedures (SOPs), or GMP.
  • Inadequate training for supervisors.
  • Low training frequency and/or lack of ongoing GMP training.
  • Insufficient number of trained personnel performing or supervising functions.

Who Needs Training?

Anyone involved in the manufacturing, processing, packing and holding of a product—including anyone who supervises those processes—needs education, training and experience to perform their assigned functions.

They also need training on general GMP requirements, especially those related to their job functions. But this doesn’t limit who should receive GMP training to those specifically involved in the manufacturing process. It may also include:

  • Upper level management.
  • IT and other support personnel.
  • Anyone whose job function directly or indirectly interfaces with GMP-regulated areas and personnel.

By expanding training to support personnel and others indirectly involved in manufacturing, GMP becomes a mindset, rather than a checklist.

How Often Should Training Occur?

According to the FDA, training should occur “on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them.” In practical terms, this means training should take place when:

  • New employees are hired.
  • You introduce a new SOP or revise an existing one.
  • Your company implements new computer applications such as quality management software or makes major changes to the system.
  • Employees undertake specific jobs and functions.
  • Corrective action identifies employee training as a root cause.
  • An employee returns from a leave of absence, or as a routine refresher.

Identifying Your Training Needs

A needs assessment is a great way to target training, identify learning objectives and ensure coverage of key processes, including those that need extra support.

This assessment can involve activities such as:

  • Interviews and surveys: Talking with individuals and conducting surveys can reveal issues that those on the front lines recognize as potential problems.
  • Performance reviews: Performance reviews can help identify areas that are recurring problems in an organization.
  • Direct observation of workers: By directly observing employees at work, you can likely identify additional training opportunities.

Key Elements of a Successful Training Program

Training programs vary depending on the needs, experience and education of the participants, and the amount of time available for training. That said, certain elements are common to all good training programs, including having a qualified trainer experienced and knowledgeable in GMP.

A standardized approach to training can also streamline the process and provide documentation to support internal and external audits. Elements of a standardized training program include:

  • Developing SOPs for training and following those SOPs.
  • Creating separate training for different groups, needs and purposes.
  • Auditing your training program to ensure compliance and pinpoint problem areas.
  • Assessing performance and evaluating needs for further training.

Automated Training Recordkeeping

Many companies use outdated methods for tracking employee training, such as recording training manually on spreadsheets and notifying workers via email about required sessions. Moving to an automated system means avoiding these inefficiencies and record keeping mistakes, allowing you to:

  • Pull information from HR profiles to determine training needs.
  • Schedule training by individual, role or department.
  • Send email reminders for scheduled training sessions (or when they’re overdue).
  • Track effectiveness with post-training assessments or quizzes.
  • Create a record of each employee’s experience and training per FDA requirements.

This type of automated system reduces compliance risks by giving you a big-picture view of your training program, so you know exactly where the gaps are and what you can do to address them.

Complying with GMP regulations can easily bog companies down in paperwork. Automated tools help ease this burden, allowing you to take action on your data rather than spending your time collecting and analyzing it.