How to Create a New Method

Best practice is to create generic methods which could be used in multiple Process Codes, however it should be instrument and test procedure specific.  This type of an approach will help in managing the system as well as gather useful reporting data.  

Methods must be created, parameters added and method approved prior to being added to Process Code.

  1. Click on Menu button
  2. Click on Static Data
  3. Click on Methods
  4. Click on Add New

1.1. Alternative Option

This option is available directly from Manage Methods Screen or Method QBE.

  1. Click on Add New Button

2. Populate Method Data

  1. Type in Method Name
  2. Status is automatically assigned by the system
  3. Click on blue text "Instrument" and select necessary instrument from pop-up list.  
  4. Or click inside of the cell and a list of available options will appear
  5. Click on necessary instrument from list to populate the textbox
  6. Type in the description of the method
  7. Press save button

3. Set Method Owner

Owner is an important field because method will not be available for use to owners not defined in this list.  When creating a new method owner is copied based on the setting of the user creating the method.

  1. Click on Owner Multi-Select Button
  2. Click on the checkbox of all owners you need to have access to this method
  3. Click Select
  4. Verify all the owners are listed in the textbox separated by tilde "~" character
  5. Press Save

4. Section "Method Parameters"

Contains all the parameters applicable to the method along with specific settings for each parameter.

4.1. Add New Parameter

  1. Click Add New Button
  2. Type in Parameter Name
  3. Click OK

4.2. Description of Fields: Method Parameters

Descriptions of fields included in Parameter set-up:

  1. Parameter Name: The internal name of the analytical characteristic being measured.
  2. Description: The external name of the analytical characteristic being measured, as it should appear on the Customer Report
  3. Units: Measurement units for the parameter (contains a look-up)
  4. Precision: The number of decimal points that should be stored for both specs and results when parameter is entered.
  5. Rounding Rule: five-up: determine what your rounding digit is and look at the digit to the right of it.  If the digit to the right is 1,2,3,4 simply drop all digits to the right of rounding digit.  If the digit to the right is 5, 6, 7, 8, 9 add one to the rounding digit and drop all digits to the right of rounding digit. five-even:  determine what your rounding digit is and look at the digit to the right of it.  If the digit to the right is 1, 2, 3, 4 simply drop all the digits to the right of rounding digits.  If the digit to the right is 6, 7, 8, 9 add one to the rounding digit and drop all digits to the right of rounding digit.  If the digit to the right is 5, then consider the rounding digit, if the rounding digit is even then round down, if the rounding digit is odd then round up.
  6. Print Flag: When box is checked then parameter will appear on the Customer Report.  When box is unchecked the parameter will be internal and not appear on Customer Report
  7. LDL: If applicable instruments Lower Detection limit for this parameter (if a result is below LDL the LDL will be shown in result along with a "<" symbol)
  8. UDL: If applicable instruments Upper Detection limit for this parameter (if a result is above UDL the UDL will be shown in result along with a ">" symbol)
  9. Calculation: Set-up if this parameters results are calculated based on other parameters and factors.  (Review Tutorial "How To Set-Up Calculations"
  10. Test Procedure Name.  C-Pro controlling document name
  11. Test Procedure Link.  C-Pro link that would redirect to most recently approved version of this procedure

4.3. Parameter Name and Description

  1. Type in Parameter Name
  2. Type in Parameter Description

Parameter Description field will appear on the Customer Report, thus visible to customer.  When a parameter has a proprietary name, it should be coded in the description field and entered directly into Parameter Name field.  Parameter Name field is kept internally and is visible only to LIMS users and report users

4.4. Define Units

  1. Option 1: Type Units directly into the field
  2. Option 2: Click in [...] to select from a predefined list.

4.5. Set Decimal Precision

  1. Click into the text box and type the number of numerical values to keep after a decimal point.  This value will be used to capture results as well as specifications in LIMS and on Customer Report.

4.6. Select Rounding Rule

  1. Click on drop down arrow to see options
  2. Click on "five-up"
  1. five-up: determine what your rounding digit is and look at the digit to the right of it.  If the digit to the right is 1,2,3,4 simply drop all digits to the right of rounding digit.  If the digit to the right is 5, 6, 7, 8, 9 add one to the rounding digit and drop all digits to the right of rounding digit. five-even:  determine what your rounding digit is and look at the digit to the right of it.  If the digit to the right is 1, 2, 3, 4 simply drop all the digits to the right of rounding digits.  If the digit to the right is 6, 7, 8, 9 add one to the rounding digit and drop all digits to the right of rounding digit.  If the digit to the right is 5, then consider the rounding digit, if the rounding digit is even then round down, if the rounding digit is odd then round up.

4.7. Set Print Flag

If you would like this parameter to show on customer report click the check box, and if not leave blank.  You can revise this setting again when performing process set-up.

  1. Shows on Customer Report when checkbox is checked
  2. Does not show on Customer Report when checkbox is unchecked

4.8. Set-Up Detection Limits (If Applicable)

  1. Type values directly into the cells

Example: pH meter for which this method is created for does not distinguish noise from an actual signal when values are below 1.  LDL is set to 1: and when a result typed in by user which is less then 1, such as 0.50, the result will automatically update to <1.00 the updated value will also be the one shown on customer report.

4.9. Calculation

This feature is described in more detail on a separate tutorial called: "How to set-up Calculations"

  1. Click to open calculation editor window
  2. After calculation is set.  Click checkbox to save and return to Method Manager screen.
  1. Type in controlling test method number from C-Pro directly into this cell.  For example pH analysis procedure is: "STM-01684"
  2. To find the correct link directly to the test procedure: Navigate to the test procedure in C-pro.
  3. Once the procedure is opened click on the paperclip inside brackets symbol to get the link that would redirect you to the most recently approved version of this procedure
  4. Highlight and copy the link in the dialog box
  5. Press Ok to close the dialog box
  6. Paste the link into Notepad window: this is done because it's easier to see the contents in a notepad window and extract the link you need before copying it into LIMS.
  7. Select only the link (which is the text between " and ")
  8. Right click and select Copy
  9. Click inside of the "Test Procedure Link" textbox
  10. Right click and Paste
  11. To test the link click on [...] button next to link text box.  This should bring you into C-pro, if required prompt to sign in.  After signing in you should be on the correct document, without having to navigate to it.

4.11. Saving Parameter Record

Note that row is highlighted in yellow and a check box is checked.  This means that changes have been made to this row which need to be saved

  1. Click button to save.

5. Adding Additional Parameters

  1. To add new parameter click Add New Button and follow steps in section 4 above to define all the settings necessary

5.1. Duplicating Parameters

  1. When additional parameters are very similar to the first one set-up you can use the duplicate function to duplicate the selected parameter.  First click checkbox to select the parameter to duplicate.
  2. Click on Duplicate button
  3. Parameters in one method cannot have identical names, so when duplicating a parameter all the data will be duplicated except for parameter name which would default to name: "DUPE_old parameter name"
  4. Rename the parameter appropriately and make any other necessary changed to the parameter record
  5. Press save when all settings are completed.

6. Section "Method Other"

This section is useful for audit and history verification.  It's automatically populated by LIMS and keeps track of version, Entered By and When and Approved by and When.

  1. Click Arrow down to expand the section
  2. Review data when necessary to track down change and approval history

7. Sections Not-Used

Sections "Method QM Area" and "Method Batch Sequence" are not used.  They do not require any editing.

8. Approving a Method

  1. When a method is ready to be approved for use click save button on main section.
  2. Click thumbs up to approve
  3. Click OK in the dialog box
  4. Note Status changed to "A"
  5. Note "Approved By" and "Approved On" cells in the "Method Other" section have been populated by the system.

Now this method will be searchable in the Sample Type Set-Up (AKA Process Set-up) Screen

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