ASSIGNMENT

Assignment

Table of Contents

NON CONFORMITY IN LABORATORY ACTIVITIES (MANAGEMENT PROCESSES)3

Cause and Effect Diagram (Fishbone Diagram)4

Corrective Actions5

NON CONFORMITY IN LABORATORY ACTIVITIES (TECHNICAL OPERATIONS)7

Cause and Effect Diagram (Fishbone Diagram)8

Causes of Hemolysis9

Evacuated Tubes9

Syringe Draws10

IV Catheters11

Corrective Actions12

REPORTING OF NON CONFORMITIES13

Technical13

Management14

ISO 15189 STANDARDS FOR IDENTIFICATION AND CONTROL OF NON-CONFORMITIES17

REFERENCES19

Assignment

The clinical laboratory encounters problems and nonconformities quite frequently during routine operation. Generally, momentary solutions are found for these problems and then forgotten since they are not documented. It is well known that documentation of every type of action is necessary for good laboratory practice. All problems and unconformities should be written in a predetermined format and these documents should be monitored and analyzed periodically(Verstraete 1996).

Non Conformity in Laboratory Activities (management processes)

An audit to the lab showed that dates appeared to cause some confusion. One observation cited staff who failed to follow the SOP for informed consent, dated February 1988. There were other non conformity incidents due to failure to follow SOP:

An unvalidated method failure to perform freeze/thaw studies when samples were repeatedly thawed and refrozen.

Failure to document the decision not to use certain data.

Failure to maintain all relevant information in the study file.

Storage temperature deviations.

Non-adherence to SOPs, such as those requiring review of internal standard peak values and "documentation of an objective, results and conclusion" in lab notebooks

Cause and Effect Diagram (Fishbone Diagram)

Corrective Actions

Whatever test or procedure is being performed, it is essential that it be performed in the same way by everyone performing it, and in the correct way. Although good training is an important part of ensuring that all staff perform procedures in the same way, a written procedure that is always followed is the only way to ensure this. Unfortunately some written procedures are just scraps of paper stuck to refrigerators and walls. Often handwritten(Verstraete 1996), they become out of date, get altered and sometimes contain only the briefest of instructions. Formal SOPs are necessary to prevent such situations. These not only describe fully the way a procedure should be performed, they also describe the only way a procedure is to be performed. In addition, because they are controlled documents, unauthorized alterations to procedures are not made and therefore all staff have a clear set of instructions to follow. An SOP should be written to cover each procedure used in the laboratory and then used by all staff when performing the procedure(Verstraete 1996).

SOPs need to be written carefully and in a specific way to ensure that they are consistent and easy to follow; they must be written in a clear manner using simple language so that the individual steps can be read as step-by-step instructions. Each SOP should cover only one procedure but be comprehensive and cover it from start to finish; however, an SOP must not be too long or it will not be followed properly. SOPs ideally should be written (at least in basic outline) by staff routinely performing the procedure, and the final copy should be checked and authorized by the head of the laboratory. Each SOP should be made a controlled document which is formally prepared, numbered ...