**Procedure for identification, control, correction and prevention of nonconformities**
===Header===
^Name^Unique ID^ Edition/Date of Edition ^
|Procedure for identification, control, correction and prevention of nonconformities|nchsls:c:general:document:02|(1) 03-01-2014|

^Preparing authority^Approving authority^Review period^
|All teaching staff|Quality Manager|1 year 


|**Printed copy of this document is considered uncontrolled.** It should be compared with controlled electronic copy before use|
======Processes requiring this procedure======
The procedure is required to carry out quality control process.
======Purpose======
It ensures that nonconformity in each laboratory process is identified, controlled, corrected and prevented, therby reducing need for risk management.
======Scope======  
All laboratory processes come under the scope of this procedure
 
======Policy of Risk Management======  
  - {{ :nchsls:c:general:document:process_chart_with_risk_management-1.ppt |}}
======Users of the procedure======
Any personnel of the laboratory involved with any process need to use this procedure.
======Procedure======= 
=====Step 0: Imagine (Risk management)=====
  *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

^  Risk Matrix  |||||||||||
| |**Effects**||||||||||
| |1|2|3|4|5|6|7|8|9|10|
|**Probability**| | | | | | | | | | 
|1| | | | | | | | | | |
|2| | | | | | | | | | |
|3| | | | | | | | | | |
|4| | | | | | | | | | |
|5| | | | | | | | | | |
|6| | | | | | | | | | |
|7| | | | | | | | | | |
|8| | | | | | | | | | |
|9| | | | | | | | | | |
|10| | | | | | | | | | |
|**Effects**\\  0=Not much effect on quality objectives \\  10=Major effects on quality objectives\\ **Probability**\\  0=unlikely\\  10=Very likely|||||||||||

  ***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


=====Step 1: Identify=====
Any personnel can identify nonconformity\\
The person is called **First information personnel**
^Common(but not the only) sources of identifying nonconformity^
|internal quality control|
|interlaboratory comparisons|
|internal audit|
|external audit|
|feedback from laboratory personnel and users of the laboratory|
|instrument calibrations|
|checking of consumable materials|
|reporting and certificate checking|
|laboratory management reviews|
=====Step 2: Inform=====
each nonconformity is informed to authorized signatory who is responsible for coordinating step-3.
=====Step 3: Take Actions=====
Authorized signatory, if required with help of other personnel, notes down properties of nonconformity; plans, implements, reviews and records actions as follows.
^Common Properties of Nonconformity Record^Common possible values^
|Source|See above|
|First information personnel|Name|
|Process affected|preanalytical, analytical etc.|
|Quality manual section/subsection affected|5.2,5.3 etc.|
|Extent|Major, Minor|
|Clinician informed(immediate control)|Yes,No, Why|
|Examination stopped being reported/performed(immediate control) and resumed|Name of examination and description|
|Reports recalled/identified as null-and-void(immediate control)|List of reports|
|summary, cause analysis, possibility for recurrance|Description, 5 Whys, Fishbone|
|Planning, implementation and review of Corrective actions|Description|
|Planning, implementation and review of Preventive actions|Description|
|Other details|Description| 

=====Records=====
^Record^Maintained at^Storage period^
|Nonconformity Record|Laboratory director level and Department/Section Level|2 years|
|Risk Management Record|Laboratory director level and Department/Section Level|2 years|