Corrective Action Response to Audit Findings Guidance

Corrective Action Response to Audit Findings Guidance

Laboratories are required to respond within thirty days of receipt of the inspection report with a corrective action response. An extension to this deadline may be granted in some cases.

The laboratory must evaluate each Finding for root cause and determine a course of action that will prevent recurrence. Laboratories must provide a written item-for-item description of how all Findings were corrected. The response must include implementation dates, steps taken to prevent recurrence and supporting documentation (e.g., log sheets, benchsheets, standard operating procedures, etc.). If the correction will not be applicable until a future date or event (such as the next time Proficiency Testing samples are analyzed), indicate that the correction will be implemented the next time that it is appropriate.

An example Finding as it would appear in a report is below:

A. Finding: The laboratory is not including units of measure (e.g., s.u.) for pH on the field benchsheets.

Requirement: Data pertinent to each analysis must be maintained for five years. Certified Data must consist of date collected, time collected, sample site, sample collector, and sample analysis time. The field benchsheets must provide a space for the signature or initials of the analyst, and proper units of measure for all analyses. Ref: 15A NCAC 02H .0805 (g) (1).

An acceptable reply from the laboratory to this Finding would be:

Corrective Action: Beginning March 3, 2016, the field benchsheet was modified to include the units of measure (i.e., s.u.) in the appropriate column headers and immediately implemented. In addition, all pertinent staff were trained on the documentation requirements for the pH test and an annual benchsheet review will be implemented to check that all current documentation requirements are met to prevent recurrence of this type of Finding.

It is important to include the following information in your corrective action response:

· corrective actions taken to correct the root cause of the problem and actions taken to prevent recurrence,

· future monitoring to check resolution – describe quality of data after corrective action,

· implementation referencing specific data and dates – is further corrective action needed, and

· data that required qualification or rejection as a result of this problem.