- 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 Study||Parameters||Frequency|
|1||Potable water||pH , TVC||Monthly Roll on Basis|
|2||Purified Water||pH, Conductivity, TOC, TVC||Monthly Roll on Basis|
|3||Environmental Monitoring of Microbiology Testing Area by Settle plate||TVC||Monthly Roll on Basis|
|4||Environmental Monitoring of Microbiology Testing Area by Air sampling||TVC||Monthly Roll on Basis|
|5||Environmental Monitoring of Microbiology Testing Area by Surface Monitoring||TVC||Monthly Roll on Basis|
|6||Environmental Monitoring of Manufacturing Area ( Functioning Area ) by Settle plate||TVC||Quarterly Roll on Basis|
|7||Environmental Monitoring (Non Functioning Area ) by Settle plate||TVC||Yearly|
|8||Environmental Monitoring of Manufacturing Area by Air sampling||TVC||Yearly|
|9||Environmental Monitoring of Manufacturing Area by Surface Monitoring||TVC||Yearly|
|10||Microbiological monitoring of Compressed Air||TVC||Yearly|
- 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 – 1||Template of Trend for Water|
|Annex – 2||Template of Trend for Environmental Monitoring|
TOC : Total Organic Carbon
TVC : Total Viable Count
QMS : Quality Management System
SOP : Standard Operating Procedure
- SOP Revision History Record :
|Revision No.||Details for Revision(s) with Change Control No.||Effective Date (Sign. / Date)|
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Annex – 1 Template of Trend for Water
Annex – 2 Template of Trend for Environmental Monitoring
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