In today’s fast past global economy some companies continue to work with outdated siloed product design systems. A lack of integration among systems creates dangerous blind spots across new product introduction processes. Due to the lack of visibility, problems can snowball fast from introduction of non-compliant parts to failed employee training.
While many companies have great PLM and Quality processes they still may lack a formal training record management process, which could result in serious business problems. Arena's medical device customers are required by federal regulations (FDA 21CFR) to train employees to ensure they are capable of adequately performing their assigned duties. If they can’t provide training records, they may be susceptible to penalties like fines or even corporate shut-down.
Employees responsible for the assembly of a medical device must be trained to ensure they are capable of performing the assembly according to the work instructions. The training process also needs to make sure employees are made aware of product defects which may occur due to improper performance of their duties. The need to prove worker training completion makes training records indispensable.
Many companies are motivated to provide employee training for various reasons, including but not limited to workplace safety, human resource training, quality initiative training and general employee development. Records document which and when employees were trained and what skills have been achieved.
Standalone or sole-purpose quality management systems may be used to spare the expense of licensing. Likewise, maintaining manual systems to manage training processes with paper or spreadsheet based processes is often chosen simply because it’s deemed more convenient. Unfortunately, these outdated siloed approaches to training may result in defective products because they are not tied to the product record.
To enable proactive compliance, Arena now allows organizations to create and manage their employee training records with in-context product information in a single system. Users can manage employee training within a single system of record with the product.
How Training Process works in Arena PLM
Employee training is dependent upon a company documenting their product and process controls in the form of written policies, standard operating procedures (SOPs), and work instructions. Once created, these documents are controlled in Arena and linked directly to the impacted employees based on their training plans.
Leveraging Arena Training, you will benefit from the following:
First, training managers can define training requirements in the form of a training plan. Each training plan defines the training materials for every impacted employee or team. These materials may include documents, presentations or even videos that pertain to how a product is assembled or how manufacturing or test equipment is operated safely.
Second, employees will be automatically notified whenever training is required.
Third, employees will be able to easily access and review the required material. They will confirm that they have "read and understood" the materials using Arena’s FDA 21 CFR Part 11 compliant electronic signatures.
Fourth, training managers will easily monitor the progress and training status for each employee. This includes selecting and viewing a Training Progress area with KPIs (Key Performance Indicators) showing how many users have completed training and how many are late. Reports may be used as training evidence during a regulatory audit or provide information on training effectiveness.
Finally, addressing internal or external audits will be simple and easy. Auditors may view reports or view Training Progress for each Training Plan to see if training is on schedule and compliant.
Arena’s all-in-one solution strengthens the enterprise with connected training, quality and product records. This eliminates the risk of having incomplete, incorrect or ineffective training management processes.
In regulated and standards based environments, product quality is impacted by the knowledge, expertise and training effectiveness of the product design, quality, and manufacturing teams. With Arena Training, your product, quality and training records are managed in a single solution. This allows companies to focus on their primary goal to deliver great products on time.