Generic Build vs. Custom Renovation

Processes and Procedures: Before—Compliance often is the baseline goal for a new company when it first develops a quality system. Therefore, the written procedures, work instructions, forms and records often are rudimentary, reflect little to no variability, and allow for minimal flexibility.

For example, the original quality system for the purchasing might follow a basic step-by-step checklist, where the first step is to provide the appropriate level of detail when placing the order and the last step is to check that the vendor sent the correct product.

Processes and Procedures: After—As vendors are added, new employees are hired and products lines are expanded, the most effective way to accommodate increased variability is to tailor the documentation for each quality system. With regard to purchasing, customizing the procedures, forms, and steps of the purchasing process can make it easier to handle suppliers and reduce risk and costs of poor quality along your supply chain. This might entail simplifying a procedure or slightly modifying a form for clarity. The point is that renovating your quality manual, records, etc., doesn’t have to mean gutting your entire documentation system and starting over. Generally, a few strategically placed improvements can greatly enhance the overall form and function of your quality system.

Renovation Tip: A gap analysis is an effective tool to use when updating the documentation and structure for your quality system. It makes it easier to map out your current quality system and illuminates what revisions will help to meet your objectives.

Training: Before—Since a startup usually has only a few employees, a single product line, and a handful of procedures, the process of training team members on how to apply the quality system often is limited to following a step-by-step to-do list. Record keeping and retrieval also are very straightforward. As time passes and the company evolves, gaps and difficulties emerge in managing the training activity and documentation. Often, the responsibility for training is blurred during company growth and the system breaks down.

Training: After—Once the quality system is customized, training team members in a way that empowers them to follow the new procedures and ensuring that training records are current and compliantly maintained requires a much more in-depth, systematized process. For example, during a review of training documentation, it may be discovered that information is being recorded in two places with no added value. Or, it might be that all personnel are being trained on every document because that was the approach used in the beginning. As the company grew the rationale for who was trained when, and on what became unclear.

Renovation Tip: To determine the updates needed in the training subsystem—and how to maintain records more efficiently—it’s important to review all current training documentation together to see how the pieces fit (or don’t). It’s also essential to talk with the main players in the process, including managers, human resource personnel, or others with training responsibilities.

A few key questions to ask are:

• What is working and what isn’t?
• What is their means for triggering a training activity? Capturing the required information?
• How do they determine who should be trained, when, and on what?

Sometimes you’ll discover that someone has created a cheat sheet to find the right training record.
These can be helpful to see what valuable information isn’t being provided by the current system.
Another technique is to do a practice run of pulling relevant training records for a person (or two) and for a document (or two). This method often will expose shortcomings of the current system that will benefit from adjustment. Once the changes are implemented into the documentation and the process, the time spent on training and related activities is significantly reduced while business benefits increase.

Audits: Before—Assessing how work is completed and ensuring that records are compliant also tends to be fairly straightforward and expeditious when a company is first building the foundation of its quality system. As such, it often is limited enough that one person can perform internal and supplier audits.

Audits: After—Once the system has matured, the auditing process becomes more involved. In addition to conducting thorough internal audits, it’s also important for the medical device company to conduct audits and other means of supplier control. At this point it’s usually no longer feasible for just one person to perform all internal, supplier and due-diligence audits from an unbiased perspective as required by regulations.

Therefore, multiple team members need to be involved in:

• Finding, correcting, and preventing gaps in the quality system; and
• Addressing any non-conformances so that the company is adequately prepared for a U.S. Food and Drug Administration (FDA) inspection or audit by a notified body.

Renovation Tip: In addition to having an experienced quality manager in place to conduct audits and training staff to do them as well, it’s beneficial to bring in outside auditors. His or her experienced, objective perspective will help ensure continued compliance and continuous improvement—especially with regard to a quality systems update. The outside auditor can assess the impact of changes being considered before, or as, they are implemented.