Procedure for Trend Analysis

  • Objective :

To lay down a Procedure for Trend Analysis.

  •   Scope :

The scope of this document is to provide the Procedure for Trend Analysis of but not limited to Water analysis results, Environmental monitoring results, in Quality Control Department.

  •    Responsibility :
  •      Quality Control Personnel  :
  •       To prepare the trends of results.
  •      To review the trend analysis results.
  •       To determine the Alert and Action Limits.
  •       Head – Quality Control :

To review and monitor procedure for Trend Analysis.

  •      Head – Quality Assurance :

To review and approve Trends.

  •     Definition(s) :

Trend: A statistical term referring to the direction or rate of change of a variable(s).

  •    Procedure :
  •   Trend analysis shall be carried out as per requirement.
  •  Trend Analysis shall contains Month, Year, Sampling point Id, Area name, Room number, Sampling frequency, Standard Test procedure number, Specification limit, Alert limit & Action limit etc.
  •   Trend shall be prepared for individual tests and sampling point for water and individual room for environmental monitoring.
  •  Plot the graph of the trend results test wise and review the same against the data for correctness.
  •    The trend is applicable to parameters as given in table in point 5.6.
  • Table for Trending parameters and frequency
Sr. No.Type of StudyParametersFrequency
 1Potable waterpH , TVCMonthly Roll on Basis
 2Purified WaterpH, Conductivity, TOC, TVCMonthly Roll on Basis
 3Environmental Monitoring of Microbiology Testing Area by Settle plateTVCMonthly Roll on Basis
 4Environmental Monitoring of Microbiology Testing Area by Air samplingTVCMonthly Roll on Basis
 5Environmental Monitoring of Microbiology Testing Area by Surface MonitoringTVCMonthly Roll on Basis
 6Environmental Monitoring of Manufacturing Area ( Functioning Area ) by Settle plateTVCQuarterly Roll on Basis
 7Environmental Monitoring (Non  Functioning Area )  by Settle plateTVCYearly
 8Environmental Monitoring  of Manufacturing Area by Air samplingTVCYearly
 9Environmental Monitoring  of Manufacturing Area by Surface MonitoringTVCYearly
 10Microbiological monitoring of Compressed AirTVCYearly
  • The trend analysis can be performed for other tests as per requirements.
  • For the above studies, the trend results shall be made for daily acquired data during validation period or as and when required.
  • Prepare the trends as per the table in point 5.6.
  • Trend shall be prepared by user, reviewed by Head of the department or designee and approved by Quality Assurance.
  • All trends shall be reviewed for its correctness and provided with the remarks. Out trend/ out of specification or absence of data other then the frequency as mentioned in respective SOP shall be reported with reference of QMS documents (e.g. change control, deviation etc.).
  •  Distribution :

   This SOP (Controlled Copy) shall be distributed to Quality Control Department.

  • Annex(es) :
Annex No.Title
Annex – 1Template of Trend for Water
Annex – 2Template of Trend for Environmental Monitoring

      Abbreviations :

TOC : Total Organic Carbon

TVC  : Total Viable Count

QMS : Quality Management System

SOP : Standard Operating Procedure

 Reference(s) :


  • SOP Revision History Record :
Revision No.Details for Revision(s) with Change Control No.Effective Date  (Sign. / Date)

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