The procedure is required to carry out quality control process.

It ensures that nonconformity in each laboratory process is identified, controlled, corrected and prevented, therby reducing need for risk management.

All laboratory processes come under the scope of this procedure

1. process_chart_with_risk_management-1.ppt

Any personnel of the laboratory involved with any process need to use this procedure.

• Risk is a potential NC. It has two components.
  • Amount of effect on quality objectives
  • Probability of its occurrence in current state of the laboratory
• For various processes identify risks.
• Put it under appropriate risk matrix as shown in table below

• Act to prevent highly probable risk with major effects on the quality objectives
• Develop plan to control and correct moderately probable risk with moderate effects on the quality objectives
• Accept less probable risk with minor effects on the quality objectives

Any personnel can identify nonconformity
The person is called First information personnel

each nonconformity is informed to authorized signatory who is responsible for coordinating step-3.

Authorized signatory, if required with help of other personnel, notes down properties of nonconformity; plans, implements, reviews and records actions as follows.