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MSA Planning

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Prerequisite

  • Access the Management > MSA Planning menu (MS003) .

 

Presentation

MSA planning is the stage in which the direction of the study is defined, including the necessary settings for the assay to be performed correctly. 

At this stage, the objective of the study is also defined and the measuring instrument is selected, reducing the likelihood of errors and rework throughout the process.

 

Plan MSA

1. Access the Management > Planning menu in MSA (MS003) .

2. To add a new MSA, in the toolbar, click the option and select the type of study to be performed.

Studies available

  • Linearity : evaluates the variation of measurement results across the instrument's range (scale); it is generally performed by a single operator.
  • Amplitude : a study of the instrument that provides an estimate of the variation in the system; it typically uses two operators and five samples.
  • RR (Mean and Range / ANOVA) : mathematical methods for estimating repeatability and reproducibility and evaluating the quality of measurement system data.
  • Bias : determined by the difference between the reference value and the average of the measurements. It can be calculated using a control chart or an independent sample.
  • Cross-tabulation : used when the goal is to assess the extent of agreement between raters.
  • Signal detection : an alternative approach to evaluate the repeatability and reproducibility of the measuring device.
  • Analytical (stability) : verifies stability over time by monitoring the results of a constant sample.
 

3. On the data screen, fill in the fields:

  • MSA No .: Provide a number or abbreviation to identify the study (according to the organization's guidelines).
  • Asset : select the asset (instrument) to be analyzed.
  • Date : Enter the planning date (the system may suggest the current date, allowing for changes).
  • MSA Type : displayed according to the selected study.
  • Documents : Select the document needed to perform the measurement system analysis. If the MSA component is integrated with SoftExpert Document, it will be possible to associate documents from the Document component. For this to be possible, the integration between SoftExpert MSA and SoftExpert Document must be done through the general system parameters.
  • Number of samples : specify the number of samples of the part that will be analyzed. For linearity and independent sample studies, this field cannot be changed.
  • Number of readings : specify the number of readings that will be performed on each sample. This field will not be displayed in the Analytical Method and cannot be changed in the Range study.
  • Team : Check the option "Define team responsible for data entry in the collection" to inform the team responsible for filling in the data collection during the execution phase.
  • Drafting and Approval : select the Responsible Routing option to indicate the routings responsible for the drafting and approval stages of the MSA.

4. Fill in the fields for the available sections in the plan:

  • General information : section containing the main fields to be filled in.
  • Characteristics : section where the characteristics of the part to be analyzed are recorded.
  • Operators : section where the instrumentation operators who will be taking measurements of the parts are associated.
  • True situation : section where the necessary markings can be made regarding the true situation of the part. See how to proceed according to the type of MSA study:
    • Cross-tabulation method : each operator must give their opinion on the condition of each sample part. When the condition is marked, it indicates that the part is compliant.
    • Signal detection method/Analytical method : each operator must record the reference value of each sample from the part in the respective field.
  • Associations : This section is where links are made to other system component records, such as documents from SoftExpert Documents, for example.

Note : Some sections will only become available after the record is saved.

5. Save the record. After saving, the system performs validations and may request that you send the MSA to the next step:

  • Confirm to proceed. If there are no inconsistencies in the MSA plan data, the record proceeds to the MSA Development stage , if defined in the approval roadmap, or the record proceeds to measurement data collection.
  • If you do not proceed, the record will remain in Planning status .

 

Conclusion

Upon completion of the planning phase, the MSA remains properly structured within the system, with the study defined, the instrument selected, and the necessary information recorded. This prepares the process to advance to the next stage, according to the workflow adopted by the organization.


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