Getting Started with QMSCAPA

1)Add human resources (employees and contractors) that have Management System (MS) roles and responsibilities.

a)Enter Departments.

b)Enter Security Aspects and Security references.

2)Add the top 20 percent of your customers into the Customer Table.

3)Add the top 20 percent of your products and/or services in the Product and Services Table.

4)Add the top 20 percent of your outsources, suppliers and/or vendors into the Supplier and Vendor Table.

a)Enter transportation carriers into the Transportation Carrier Table.

5)Add customer complaints into the Customer Complaints Log. If possible go back into your existing customer complaint records and enter complaints from the previous year. Entering the historical data provides a good practice method and will help you ascertain trends.

a)Add customer complaint reason codes into the Complaint Reason Code Table.

6)Copy customer complaints that should have a 'root' cause analysis into the CAPA log.

7)Enter CAPAs from other sources into the CAPA log.

a)Enter CAPA types.

b)Enter MS Processes.

c)Enter Preventive Action Classifications.

d)Enter Proof of CAPA effectiveness, as appropriate.

e)Enter CAPA Status list.

8)Identify the documents under revision control of your management system. Enter the appropriate information into the Document Control Index.

a)Enter Document Types

9)Enter Training Programs.

a)Enter Training Schedules.

b)Schedule Personnel for Training, as appropriate.

c)Evaluate record training effectiveness.

10)Enter Monitoring and Measuring Devices into the Monitoring and Measurement Device Table:

a)Record calibration methods and intervals.

b)Record maintenance methods and intervals.

11)Enter Customer Satisfaction Survey elements (questions and rating methods), as appropriate:

a)Prepare Customer Satisfaction Surveys, as appropriate.

12)Enter Supplier Evaluations elements (evaluation methods), as appropriate:

a)Prepare Supplier Evaluation templates, as appropriate.

13)Enter Internal Audit elements and processes:

a)Enter the Audit Schedule.

b)Enter observations and findings from your last internal audit, as appropriate.

14)Determine the values for determining Risk Priority Numbers (RPN), which are derived from Risk Impacts:

a)Enter Risk Assessments.

b)Enter Risk Assessments Aspects.

15)Enter Checklist, as appropriate for Operational Controls and/or Product Realization.

16)Enter Quality Metrics for Monitoring Quality:

a)Results from customer satisfaction surveys.

b)Results from manufacturing and/or production activities.

c)Results from delivery and shipping activities.

d)Results from purchasing activities.

e)Results from contracts, orders and other sales activities.

f)Results from outsource, supplier and vendor evaluations.

g)Enter QMS Dashboard settings.

17)Enter key referenced documents (not under revision control)

18)Modify QMSCAPA forms and reports, as appropriate.

 

 

 

 

 

 

 

 

 

 

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