The use of SOPs (Standard Operating Procedures) is necessary across all regulated industries to ensure that employees work in a safe and compliant manner. All employees must therefore receive SOP training. As SOPs are detailed descriptions of the steps to take in performing a task, they are a common area of focus during facility inspections by regulatory authorities both in the United States and the European Union.

A growing trend in regulated industries is conversion of static, paper-based SOPs to interactive, multimedia e-Lessons. The use of graphics, animations and interactivity not only increases comprehension and understanding but also provides a more enjoyable learning experience for employees.

CompuPharma’s SOP conversion service operates on 4 different levels (Level 1 – Level 4) with each increase in level reflecting an increasing sophistication in the degree of conversion.

The conversion levels are as follows:

Level 1

Level 2

Level 3

Level 4

Storage, distribution and version control of electronic SOPs can also be more time and cost effective. Skillpad, CompuPharma’s Learning Management System, can fulfil all of these functions securely (Part 11 compliant) and efficiently.

 

2. SOP Assessment

More and more regulatory bodies are insisting on proof that SOP training is effective. The traditional proof of knowledge transfer – a signed “read and understood” hard-copy statement – is no longer adequate.

CompuPharma is assisting its clients in addressing this problem by enabling employees to assess themselves on SOPs electronically using a robust, secure assessment engine (Skillpad). This assessment asks the employee client-approved questions that are designed to provide proof of knowledge transfer. The assessment results are stored electronically for internal training management and regulatory purposes.

Increased emphasis on SOP training can be traced to FDA’s introduction of its Systems Based Inspection program for pharmaceutical manufacturers in 2002. Since this introduction, emphasis on training during regulatory inspections has increased.

Basically, the Systems Based program sees each part of a pharmaceutical operation as a system. Thus, there is a Quality System, a Production System, etc. To function in compliance with industry regulations each of these systems requires employees who are competent in the tasks of that system. In other words, they must have the necessary knowledge and skills to perform their jobs properly.

To achieve competence, each job function must first be described in terms of required competencies (Needs Analysis). Once this is done, an appropriate training program can be devised and implemented.

As part of an inspection of each system, training/qualification of personnel is specified as one of the areas FDA inspectors must examine. According to FDA’s Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections: “For…training/qualification of personnel,…the firm should have written and approved procedures and documentation resulting therefrom. The firm's adherence to written procedures should be verified through observation whenever possible.”

Key procedures in achieving employee competence are SOPs (Standard Operating Procedures). SOPs provide detailed instructions on how to perform certain tasks or procedures in a consistent way. They are therefore a key part of all training programs. Since many procedurized tasks are critical to product quality (e.g. a manufacturing process, an analytical method) the corresponding SOPs are frequently examined by FDA inspectors.

Many companies have their employees ‘sign-off’ on an SOP to state that it has been read and understood. Yet this sign-off in itself doesn’t prove that the information or knowledge has been transferred from the SOP to the learner. It simply proves that the words were read but not necessarily understood.

In the current regulatory climate, proof of knowledge transfer during training is being viewed as necessary to determine if personnel are trained/qualified. An example of proof is a successfully completed assessment. Our experience from talking to clients is that more and more companies are introducing multiple choice assessments as a means of evaluating employees’ knowledge of certain SOPs.

This is not an easy task. With many companies having in excess of 500 SOPs, there is potentially a huge administrative burden on Training Departments to produce the required assessments for each SOP and to ensure each employee is assessed.

CompuPharma develops assessments routinely as part of its e-Lesson production cycle. With our expertise in this area we can not only help you develop an SOP assessment program, we can also assist you in identifying training needs and formulating and implementing your training programs.

In addition, CompuPharma has the technical expertise to automate the SOP assessment process using an “assessment engine”. Using this engine, SOP assessments can be taken electronically and the results stored in a secure Part 11 compliant database. The assessment engine can also be configured to interact and ‘talk’ to existing applications such as document management systems.

Please contact us for more details on our SOP services.