Inspections, Compliance, Enforcement, and Criminal Investigations
Guide to Inspections of Medical Device Manufacturers
There is no official definition of a small manufacturer, although 10 or fewer employees is often used as the rule of thumb. An investigator should realize that a small firm usually does not need the same degree of documentation necessary as required for a large firm to achieve a state of control. Many of the written procedures required by the Quality System/Good Manufacturing
Practices may be more brief and less detailed for a small manufacturer or a manufacturer of less complicated devices, unless the firm is producing nonconforming devices. Evidence that the firm is producing nonconforming devices may indicate the need for more detailed procedures.
t a minimum, the small manufacturer must have the following:
a. Adequate space for components, finished devices, and manufacturing processes
b. A DMR containing the production and device specifications
c. Testing/release according to specifications
d. A DHR containing the test results
e. Training/qualifications of employees
f. Audit procedures
An investigator who understands the purpose and meaning of the various QS/GMP requirements will not merely follow the words verbatim, but will apply the requirements properly to any operation which applies to the device manufacturing firm. If the guidance in the book entitled "The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices" is followed, an investigator can apply them to any situation, regardless of the size of the firm or the complexity of its operations.
The new Quality System/GMP Regulation has numerous references to establish and maintain certain procedures. Establish is defined as define, document and implement (do).
The purpose of written procedures is to provide instruction and guidance, to assure uniformity and completeness, and for communicating and managing operations.
In large manufacturing operations involving many unskilled people and multiple operations, detailed written procedures are usually necessary. In a small firm, communication lines are usually short, fewer people are involved, and management is readily available to provide guidance so that the length and depth of written procedures is usually less.
Often, training and work experience are valid substitutes for detailed written procedures. For example, machinists are typically skilled personnel who fabricate components and finished devices using dimensional drawings for guidance instead of written procedures. The investigator must evaluate each situation and determine the need for a detailed written procedure on the basis of training and the knowledge possessed by the operator and the control needed. Typically, a detailed written procedure may not be necessary when:
a. The activity is very simple.
b. Straight forward quantitative rather than qualitative standards determine acceptability.
c. The operation is performed by skilled personnel.
In a small firm, the investigator may conclude that the Quality System/GMP Regulation for a written procedure is not needed, except where appropriate. Such a decision, however, must be supported by observation that sufficient control is present to meet the intent of the written procedure, and the fact that nonconforming devices are not being produced.
When the Quality System/GMP Regulation requires a procedure, all appropriate procedures shall be "written." If the manufacturer does not have the applicable procedure, the investigator must evaluate the controls in place and determine if they are adequate without written procedures. Such decisions can be made taking into consideration such factors as the number of mistakes, rework, rejects, complaints, etc., that can be related to the operation for which the procedures are intended.
Every time the QS/GMP requires a written procedure, it does NOT mean a separate, discrete procedure. Many of the required written procedures can be combined and written up as system procedures or procedures that cover several areas, i.e. "packaging, distribution, installation."
An investigator should not insist that a manufacturer meet a QS/GMP requirement that does not contribute to assuring conformance to specifications simply because it is part of the new regulation. Section 519(a)(4) of the FD&C Act prohibits record keeping requirements that are unduly burdensome to a device manufacturer.