820.25 Personnel.

(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.

Interpretation:

This key requirement of training must be documented to demonstrate that your organization is following this.  In-house training is important but where a particular skill requires schooling such as (engineering and microbiology, etc) this should be demonstrated.  Having a copy of the employees diploma and certificates should be helpful in demonstrating to the FDA that your employee has the essential credentials.

(b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.

Interpretation:

Job descriptions should have a requirement as to the educational background of the person qualified to do a certain job. 

(1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.

Interpretation:

At least once a year you should review your procedures with your personnel.  It is also advisable to keep a log of device defects that arose due to improper performance (also known as operator error).  It is also beneficial to have much expeditious reviews of “fresh” defects to correct the problem early enough and prevent future occurrences. 

(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.

Interpretation:

Verification and validation activities are critical in establishing the safety and effectiveness of a device.  With this important responsibility comes the need to educate all who partake in such activities the ramifications that may occur if procedures are not followed.  This also includes the actions that must be taken when discrepancies are encountered.

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Reference: www.FDA.gov

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