OR WAIT null SECS
Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.
The opening presentation gives the company a chance to put their best foot forward, according to Siegfried Schmitt, principal at PAREXEL.
Q: Our manufacturing facility is inspected regularly by various agencies. There are differences between these inspections, but one constant is that we always kick off with an opening presentation. Do you have any suggestions how we can make our opening presentations most effective?
A: This is an astute observation, and it is indeed important to give the opening presentation much thought. In fact, the opening presentation is the only time when a company is in control during an inspection and is the opportunity for the company to present the information that they consider important.
Let us consider what makes an opening presentation stand out and achieve its objectives. The main objective should be to present the company and facility being inspected in a positive light. Think of the inspectors as customers; ask yourself the following so you may provide the essential information they seek: What do they want to know? Why are they here?
The following are some practical suggestions to prepare for the presentation:
The presentation should be complete, reviewed, and approved weeks before the inspection. Trying to improve it minutes before the inspectors arrive is never a good idea. Mostly companies use programs such as Microsoft PowerPoint, which works well, so long as presentations do not become overwhelmed by unnecessary transitions or effects.
The length of the presentation should not exceed 30 minutes, if possible. It is not uncommon for inspectors to cut presentations short if they think that time is being wasted. One should allocate three minutes per slide, considering time for potential questions to be addressed. While additional slides can be prepared, they should be kept as backup.
Technology should be thoroughly checked the day before the inspection to ensure that all is in working order. A back-up copy of the presentation should be ready on a portable device, just in case.
The presenter can be the head of quality, the site manager, or the sales manager. The exact title or role of the chosen presenter is less important than their competency and confidence when discussing the contents of the presentation. Far too often, presenters click through a slideshow without portraying passion or genuine interest. Presenters should communicate that they are proud of their plants, quality systems, and place of work. Inspectors will pick up on a lack of enthusiasm and that often impacts inspection results.
After the inspectors have arrived, the presentation can begin. A color copy of the slides (one slide per page) should be printed and be available for inspectors so that they can take notes and make annotations.
A presentation’s contents should include a site layout plan, one to two key organizational charts, key operations on site, and inspection history. But what about the quality system? As one inspector put it: ‘usually the level of quality is inversely proportional to the number of times quality is mentioned in the opening presentation.’
In recent years, inspectors’ time is at a premium. It is key that only essential, pertinent facts and figures are included in the slides shown, presenting a company’s commendable aspects, people, and systems. If your presentation follows these suggestions, respecting the time and needs of inspectors, you should see happy inspectors beginning their work, which will ideally lead to a positive inspection.
Vol. 30, No. 7
When referring to this article, please cite it as S. Schmitt, “Inspections: The Value of the Opening Presentation,” BioPharm International 30 (7) 2017.