Certificate of Analysis
The management is located along the path Quality > Item Controls > Certificates of Analysis > New Certificate of Analysis or it can be executed from the Search Certificates of Analysis.
The Certificate of Analysis certifies that a certain item complies with the characteristics specified by the Data Sheet or in the Customer specifications, also certifying the checks performed on the product, the compliance with the limits indicated in the Control Plans, and accompanies the sale of the product.
Certificates can be generic or customized. If customized, it will be necessary to enter the Customer.
Standard reports are available for:
Certificate of Analysis: a sheet that lists the Products with details of the Tests performed, Values detected, and the Result obtained.
Declaration of Conformity: a sheet that certifies and guarantees the conformity of the Product.
Command Buttons
Save
Pressing this button saves all the modified information of the displayed Certificate of Analysis.
Import Controls
Pressing this button searches for Approved Item Controls to associate with the displayed Certificate of Analysis.
A management interface appears for searching and selecting the Item Controls to import into the Certificate of Analysis.
Only Approved Item Controls that meet the required data filter are listed.
Pressing the Select button duplicates the selected Item Controls and includes them in the displayed Certificate of Analysis.
Update
Pressing this button updates all the information in the displayed Certificate of Analysis.
Data Management
Header Data of the Document
The managed information includes:
Certificate Type: it is the type of the document (mandatory data).
When entering a new Certificate of Analysis, the Certificate Type indicated in the expander Certificates of Analysis of the General tab in the Item Control Parameters is proposed.Year/Number/Date: these are the Year, Number, and Date of the Certificate of Analysis (mandatory data).
Upon entering a new Certificate of Analysis:
- the Date is proposed as today’s date;
- the Year and Number are proposed based on the Date and the Numeration associated with the Certificate Type.
Customer: this is the legal entity of the Customer to whom the document will be sent.
Header
The managed information includes:
Responsible: this is the Employee responsible for the Certificate of Analysis.
When manually entering a new Certificate of Analysis, the Responsible indicated in the expander Certificates of Analysis of the General tab in the Item Control Parameters is proposed.External Reference: this is the Business Function responsible for the Corrective Action.
Customer Note: free annotations.
Our Reference: free annotations referring to internal documents.
Your Reference: free annotations referring to external documents from the customer.
Description: free annotations.Completed/In Date: expander where the following can be entered:
Completed: indicates that the Certificate of Analysis has been Completed.
Upon completion, the following are automatically proposed: In Date (completion date) proposed as today’s date and can be changed, Completed By linked to the Employee associated with the A.R.M. User who logged in.
Notified/In Date: indicates that the Certificate of Analysis has been Notified to the customer on the specified date.
Upon notification, the following is automatically proposed: In Date (notification date) proposed as today’s date and can be changed.Audit Trail: read-only expander where the following information is visible:
Annotations
The managed information includes:
Internal Notes: free annotations.
Printable: indicates whether the Internal Notes are printable in the reports: Certificate of Analysis and Declaration of Conformity.
Control Plan Notes: free annotations regarding references to used Control Plans.
Printable: indicates whether the Control Plan Notes are printable in the reports: Certificate of Analysis and Declaration of Conformity.
Other Notes: free annotations.
Extra Data
It is possible to enter Extra Data for each Certificate of Analysis.
Controls and Detected Values
The managed information includes:
Item
Number: this is the line number of the document.
Type Line: this is the line type of the document. In the version, only the Type Line: 1 - Coded Item is managed.
Class: this is the class of the Item of the controlled document line.
Item Code: this is the code of the Item of the controlled document line.
Item Description: this is the description of the Item of the controlled document line.
Loading Unit: .
Batch: .
Serial Number: .
Unit of Measure: this is the Unit of Measure of the Document Quantity of the controlled document line.
Quantity: this is the Document Quantity of the controlled document line.
Alternative Unit of Measure: this is the Alternative Unit of Measure of the Document Quantity of the controlled document line.
Alternative Quantity: this is the Alternative Document Quantity of the controlled document line.Item Controls
Type: this is the code of the Item Control Type.
Type Description: this is the description of the Item Control Type. This information is read-only.
Number: this is the number of the Item Control. This information is read-only.
Date: this is the date the Item Control was entered. This information is read-only.
Detected Values
It contains the list of Tests for the Item.
The information is inherited from the *Tests of the Imported Item Controls and can be modified using the same logic used in the management of Item Controls.
The list includes the following information:
Sequence: this is the sequence of implementation of the Tests.
Test Type: this is the code of the Test.
Test Type Description: this is the description of the Test. This information is read-only.
Unit of Measure Detected Values: this is the Unit of Measure used to express the Typical Value, the Minimum and Maximum Limits if expressed in value and not in percentage, and the Detected Values.
Value Type: this is the Value Type used to express the Typical Value; the possible Value Types are: Numeric, Yes/No or Text.
Limit Type: enabled if the Value Type is Numeric, this is the Limit Type that will drive the enabling of the Limits and Tolerance values.
Typical Value: this is the expected theoretical value of the Test.
Minimum Limit: minimum limit allowed compared to the Typical Value.
L.min.(toll-): this is the negative tolerance limit on the minimum limit.
L.min.(toll+): this is the positive tolerance limit on the minimum limit.
Maximum Limit: maximum limit allowed compared to the Typical Value.
L.max.(toll-): this is the negative tolerance limit on the maximum limit.
L.max.(toll+): this is the positive tolerance limit on the maximum limit.
%: indicates whether the Minimum Limit and the Maximum Limit are expressed as a percentage.
Detected Value: this is the detected value of the Test that will determine the Result.
Upon entering the Detected Value:
- in Detected By is proposed the Employee associated with the A.R.M. User who logged in;
- in Detected By User is proposed the A.R.M. User who logged in;
- in Result is proposed the result of the Test and can be modified later.
- in Test Result Date is proposed today’s date and can be modified later.
Average Values Detected: this is the average of the detected values in the Multiple Value Detection of the Test.
Detected By: this is the Employee who entered the Detected Value.
Upon entering the Detected Value, this information is proposed as equal to the Employee associated with the A.R.M. User who logged in.
Detected By User: this is the A.R.M. User who entered the Detected Value.
Upon entering the Detected Value, this information is proposed as equal to the A.R.M. User who logged in.
Result: this is the positive or negative result of the Test.
Upon entering the Result, today’s date is proposed in Test Result Date and can be modified later.
Upon entering the Detected Value or the Average Values Detected, this information is proposed based on the Value Type, Limit Type, Typical Value, Limits, and Tolerances entered.
Printable: indicates that the Test is printable.
Approved: indicates that the values and the Result attributed to the Test have been Approved.
Upon approval, the Approval Date for Result is automatically proposed as today’s date and can be modified; all information of the Test cannot be modified anymore.
Multiple Detected Values
Contains the list of measurements taken for a single Test.
These are also inherited from the *Tests of the Imported Item Controls and can be modified using the same logic used in the management of Item Controls.
The list includes the following information:
Sequence: this is the sequence of execution of the measurement.
Position: free annotations related to the position of the measurement.
Detected Value: this is the value detected by the operator.
If the Detected Value is of type Numeric, the average of the Detected Values entered in this list for the selected Test will be inserted in the Average Values Detected column of the selected Test, determining its Result.
Upon entering the Detected Value:
- in Detected By is proposed the Employee associated with the A.R.M. User who logged in;
- in Detected By User is proposed the A.R.M. User who logged in;
- in Detected On the current date is proposed.
Measuring Tool Used: this is the reference to the Measuring Tool used by the operator to obtain the Detected Value.
Detected By: this is the Employee who entered the Detected Value.
Upon entering the Detected Value, this information is proposed as equal to the Employee associated with the A.R.M. User who logged in.
Detected By User: this is the A.R.M. User who entered the Detected Value.
Upon entering the Detected Value, this information is proposed as equal to the A.R.M. User who logged in.
Detected On: this is the date when the operator entered the Detected Value.
Upon entering the Detected Value, this information is proposed as today’s date.
Notes: free annotations.
Description of Measuring Tool: this is the description of the Measuring Tool used.
Detected Values Details
Contains additional information associated with the selected Test.
The information is inherited from the *Tests of the Imported Item Controls and can be modified using the same logic used in the management of Item Controls.
The managed information includes:
Internal Test: indicates whether the Test is conducted internally or at an external laboratory.
Sending Date: this is the date when the necessary materials to conduct the Test were sent to the External Laboratory. This information is read-only if an Internal Test is indicated.
External Laboratory: this is the legal entity of the Supplier that will conduct the test. This information is read-only if an Internal Test is indicated.
Test Type: this is the code and description of the Test.
Frequency Category: free annotations related to the sampling frequency.
Number of Detections: this is the number of minimum values suggested for measurements.
Measuring Tool Used: this is the Measuring Tool used to detect the point value of the Test.
Start Date/End Date: these are the start and end dates of the Test.
Test Result Date: this is the date the Result is assigned.
Upon entering the Result, this information is proposed as today’s date and can be modified later.
Description on Result: free annotations on the subject.
Approval Date: this is the date when the Approval of the Test was made.
Upon entering the date, the Approved flag is automatically set.
Approval Description: free annotations on the subject.
Test Notes: free annotations on the subject.
Other Notes: free annotations.
Other Test Data
It is possible to view Extra Data for each row of Detected Values of the Item/Item Controls row.
These are inherited from the Attributes of Conducted Tests associated with the Tests of the Item Controls.
Item Attributes
It is possible to enter Extra Data for each row of Detected Values of the Item/Item Controls row.
Attached Documents
In this list, it is possible to enter and consult any attachments associated with the row of Detected Values of the Item/Item Controls row.
Detail Data of Controls
The managed information includes:
Control Plan Reference: this is the reference to the Control Plan used for the tests and the detected values. This information is read-only.
Control Description: this is the description of the linked Item Control. This information is read-only.
Control Notes: free annotations on the subject.
Item-Customer Notes: free annotations on the subject.
Data Sheet Reference: this is the reference to the Data Sheet linked to the used Control Plan. This information is read-only.
Source Document: this is the reference of the Source Document Type on which the Item Controls were performed. This information is read-only.
Source Document Reference: this is the reference of the Source Document on which the Item Controls were performed. This information is read-only.
Notes: free annotations.
Other Control Data
It is possible to view Extra Data for each row of Item/Item Controls.
These are inherited from the Attributes of Controls associated with the Item Controls.
Item Attributes
It is possible to enter Extra Data for each row of Item/Item Controls.
Attached Documents
In this list, it is possible to enter and consult any attachments associated with the row of Item/Item Controls.
For everything not detailed in this document regarding the common functionality of the forms, please refer to the following link Custom Features, Buttons, and Fields.