Defuse Quality Problems Before They Happen
Product recalls, consent decrees, 483s, lost batches. We all know what happens when drug manufacturers lose control of a critical quality parameter, or fail to estimate infrastructure needs. Experts agree that data monitoring, trending and analysis are all that is needed. But thats often easier said than done. Deciding which data points are the most critical to product safety and quality can be challenging.
Proactive manufacturers prioritize efforts effectively, using various methods and technologies to focus on areas that will yield the greatest return, have the greatest impact on product quality and safety, and optimize process control. The following are case studies in proactivity, approaching the topic from different angles.
As these articles show, optimizing quality proactively is not only possible, but is becoming an established practice for more pharmaceutical manufacturing operations. Is yours among them?
Demonstrating a high degree of sterility assurance is critical to successful aseptic processing. Each process step and each component introduces opportunities for error that can lead to a loss of sterility assurance. The variety of utility systems, lab systems and clean room systems involved in the process further add to the complexity. Proper validation and control of the manufacturing system is crucial since the product may not be suitable for terminal sterilization in its final packaging.
This article describes a proactive method of improving sterility assurance using a risk-based approach. This initiative focused on the use of Failure Mode and Effects Analysis (FMEA) to identify potential weak points in the sterility management process.
The manufacturing facility described here is still early in its life cycle. Thus far, the sterility program has been solid, with no failures and few questions about the assurance of sterility. Despite this good performance, a proactive approach was taken to identify potential failures in our system. In the spirit of continuous improvement, we thought it was important to leverage our good experiences in sterility management as we sought to improve our existing process.
Typically, an FMEA would start with a detailed review of historical failure data. This step is important to remove opinion and conjecture from the analysis. However, with limited historical data on loss of sterility assurance, we sought information from process experts to help identify potential areas of concern. The first step was to interview a number of subject-matter experts across our corporation, including personnel in quality assurance, validation, manufacturing and the QC labs.
Next, our team sought ideas from operations personnel across the site. Groups from each of the aseptic manufacturing areas, the utilities area and microbiology were consulted. Brainstorming sessions with each of these groups across several shifts were organized.
Our team was concerned that traditional verbal brainstorming might inhibit responses from some individuals who might be uncomfortable in a group. There also was a concern that more dominant individuals would take over the conversation and thus we would miss some good information from quieter personnel. Therefore, our team made use of an alternative brainstorming method called Brainwriting 6-3-5.
This technique is a written brainstorming tool that refers to having six people each write down three responses to a problem in five minutes. Each participant begins with a worksheet divided into five rows of three columns. A question or problem statement is listed at the top of the page. Each person records three responses to the problem or question within five minutes. Each worksheet is then passed to the left and a new five-minute period begins. Each person reads the first three responses and then writes down three more ideas until the table is full.