Biomedical Engineering Reference
In-Depth Information
1. operational staff and their supervisors;
2. quality unit auditors;
3. regulatory investigators;
4. health care providers;
5. patients and other health care consumers.
In brief, operational staff manufacture the regulated product,
be it a drug, medical device, nutritional supplement, etc. The
quality auditors function independently to monitor the
activities of operational staff as well as the quality attributes
- the Safety, Identity, Strength, Purity, and Quality (SISPQ)
of the product. Agency investigators in turn regulate the
activities of both operational and quality staff. Health care
providers prescribe the product, and patients utilize the
product.
Any member of these groups can make an observation that
may bring about an investigation and RCA. Consider several
illustrative observations:
■
A forklift operator raised the forks too high and
damaged a fi re sprinkler head. The water was under high
pressure and it not only fl ooded the area but cascaded
down to the fl oor below, threatening to inundate
production areas. After an engineer shut off the water
supply, operational staff escalated this event to
management.
■
The quality unit of a FDA regulated blood center reported
an increase in the number of BacT Positive samples, which
might be indicative of contamination with tuberculosis
bacteria. The samples turned positive over the weekend.
An investigation was initiated.
■
FDA 483
Observation to Genzyme
dated 13 November
2009, for example, pointed out that Genzyme's:
