google-site-verification: google00a120e16d1a8984.html QDMS Quality Data Management System Overview

                                                                                                        

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 QDMS - Quality Data Management System

QDMS is a manufacturing-centric laboratory information management system (LIMS) designed to manage all aspects of the Product Quality Plan including the creation and management of:

 

   Test Methods   Testing and Re-Testing
   Test Plans   Product Quality State Assignment
   Specifications   Product Certification (CoA)

QDMS is organized into two work spaces:

QDMS Admin Panel. This is where quality system administrators define all aspects of the product quality plan. This includes defining when a product will be tested, what tests are required, and what specifications apply given the product, customer, and step of the manufacturing process.

QDMS Console. This is the interface that users engage when executing the product quality plan. The console is where users enter product samples, see what testing needs to be completed, and enter the results of the required tests. The Console also facilitates the creation of CoAs and the assignment of a quality state (e.g. approved, rejected, hold).

 

 

 QDMS Console

Sample Creation


  

Samples brought to the QC Lab are logged into QDMS by completing the Add Product Sample form (or by simply scanning a bar code). Once entered, the sample will appear on the laboratory's "to-do" list.

 

 

Sample Testing


The Sample Summary is the Lab's "to-do" list, showing all Samples that require testing.
Samples requiring testing can be filtered by: Operation, Test (e.g. show all Samples requiring a pH), and Show All (default). Additionally, the Sample Search provides easy access to all samples from any product or lot number.
Samples can also be sorted (ascending & descending) by clicking any of the column headings.
Double-clicking on a desired sample launches the Test Results window.

 

  

Test Results Entry

The Test Results window is the primary interface where test results are entered.
This window is organized into three sections: 
  1. Job Information Frame - Product, lot, and customer information from the Job Master table.
  2. Sample Information Frame - Sample information from the Sample Creation step.
  3. Test Results Tabs - Organizes test result entry by Test Type:

Testing Summary Tab: Summarizes (by Test Type) the status of all Tetsts required for the chosen Sample. Also enables disposition assignment for users with proper credentials.

Attribute Testing Tab: Enables the technician to enter attribute test results. 

Variable Testing Single Input Tab: Enables the technician to enter variable test results where the spec is based on a single value.

Variable Testing Multi Input Tab: Enables the technician to enter variable test results where the spec is based on the average or range of multiple values. QDMS even accomodates testing from multiple locations on the same sample (e.g. left, middle, right).

Add Comments Enables technicians to record comments regarding the testing process. View Comments enables users to see all comments associated with the sample.

For each required test, QDMS provides the Test Name, Method Number, Test Number, and Specifications. Warning Limits can also be displayed. Once a test is performed, QDMS shows who did the test and when it was completed.
The Method Number can be hyperlinked to display the applicable SOP.
Test results that are out of warning limits are highlighted with a yellow background.
Test results that are out of specification are highlighted with a red background.
Test results that are within specification are highlighted with green text.

Re-Testing: Re-testing a product sample is initiated by right-clicking on a desired test and selecting "Re-test." In such cases, the Test Number will increment to 2. An unlimited number of re-tests can be perfromed. The last re-test result is the value that appears on an applicable CoA.

Ad-Hoc Testing: Additional tests (not already included on the Test Plan) may be added to any sample by clicking on the Add Test button in the icon bar. The results for "added" tests do not appear on a CoA.

Test Deletion: Required tests can be deleted, with proper security, by clicking on the Remove Test icon. Deleting a test from a sample does not permanently remove the test from the Test Plan.

 

Certificate of Analysis (CoA) 


   

To create a Certificate of Analysis (CoA), first select the Customer ID, the Product ID, and the applicable Lot Number(s). Then, for the lot(s) being shipped, simply select the Unit Numbers (drums, rolls, pieces, etc.) that are to be included on the CoA. QDMS supports building CoAs with multiple Product IDs, each with multiple Lot Numbers and Unit Numbers. 

Upon creating a CoA, click the Show Instructions button to see how to process it.

CoAs are stored as .PDF files. QDMS makes it easy to Retrieve and Reprint CoAs if needed.

QDMS uses a best-practice CoA format with two options for displaying the test results:
Detail CoA - Shows the test results for every unit of every lot tested.
Summary CoA - Shows the average result of every test performed, and how many samples were tested to determine the average.

 

 
 

 QDMS Admin Panel

Overview


  

The QDMS Admin Panel is organized into two sections:
1. Global Setup - Where "global" information is defined such as facilities, operations, sample locations, sampling frequencies, and user security is managed.
2. Testing Setup - Where tests, test plans, specifications, and CoAs are defined and managed.

 

 
 

 QDMS Admin Panel - Global Setup

Operations


  

At a macro level, testing is organized by Facilities and Operations. Each Facility (e.g. production plant) is organized into Operations (e.g. production lines or areas). Each Operation can be further organized into unique Workcenters (e.g. machines or production steps). This logical organization makes the analysis of historical data (for process improvement purposes) more efficient and effective.

 

 

Facilities


QDMS enables real time access to product test results in any facility around the world.
Each Facility (e.g. production plant) has its own facility-specific Signature Authority and Quality Certification Statement that appear on CoAs issued by the facility.

 

  

Sample Locations

QDMS Sample Locations enable performing tests from multiple sample locations on a single sample.        
 For example: 
 - First, Middle, Last.
 - Left, Center Right.
 - Top, Bottom.

 

 

Test Frequencies 

QDMS Testing Frequencies support both Time based and Unit based product testing.                       
For example:
 - Time Based Testing Frequencies = Every 10 minutes, 30 minutes, 60 minutes, etc.
 - Unit Based Testing Frequencies = 1st, 2nd, 3rd, last, every other, once per lot, etc.

 

 

Security 

QDMS User Groups provide the ability to limit the access to information within QDMS, and to limit the ability to perform tasks (e.g. product dispositioning). QDMS provides two log in security options:
  1. Windows Authentication.
  2. QDMS Integrated Security.

 

 

 

Enterprise Data Sync 

QDMS is designed to retrieve customer, product, and production information from your existing application database(s) (MRP, ERP, MES, AS400, etc). Therefore, you will continue to use your existing systems to define customer, product, and production information.

 

 

 
 

 QDMS Admin Panel - Testing Setup

Tests and Test Methods


  

The population of tests that can be run on any product are organized by Tests and Test Methods

Each Test may have an unlimited number of Test Methods.
Each Test Method has a pre-defined Data Type: Attribute or Variable.
Each Test Method may be linked to its Work Instruction so that technicians can easily see how to perform the required test.
Each Test Method also has definable Sample Locations.

 

 

Product Quality Plans


The Product Quality Plan defines those tests that are required on any given sample depending on:
- What the Product Number is.
- What step of the production process the sample came from.
- Who the targeted customer is.

QDMS' robust product quality plan management capability accommodates two types of test plans:
Product Test Plans define those tests that are required for a Product being manufactured for any customer that does not have a defined Customer Test Plan.
Customer Test Plans define those tests that are required for a Product being manufactured for a specific customer.

In addition to defining required tests, Test Plan definition records:
Whether "Auto Approve" is on or off.
Any special instructions that QC Technicians need to be aware of.
The applicable Sampling Frequency of each test.
Weather the result appears on the CoA (tests may be required for dispositioning purposes, but may not appear on the CoA).

 

  

Specifications

QDMS makes product specifications management easy by providing the ability to define and manage specifications at three levels:

Test Method Specs are specifications defined at the Test Method level and apply to the applicable Test Method. Changes to a Test Method Spec will also change the specifications of all Product Test Plans and Customer Test Plans containing the applicable Test Method.
Product Specs are specifications defined at the Product level and apply to the applicable product when being manufactured for a customer who does not have defined Customer Specs (see below). In other words, if the existing Test Method Spec does not apply to a certain product, then a product-specific specification can be defined.
Customer Specs are specifications defined at the Product/Customer level and apply to the applicable product when being manufactured for a customer that requires a specification different that that defined by the general Product Spec. In other words, if the Product Spec does not apply to the applicable Customer, then a customer-specific specification can be defined.
QDMS does not automatically create a Customer Spec for each Customer Test Plan. Customer Test Plans use the Product Spec unless a Customer Spec is defined.

 

 

Certificate of Analysis (CoA) 

In the same manner that QDMS provides robust specifications management, Certificates of Analysis can be defined and managed at three levels:

Facility CoA defines the text contents that appear on all CoAs that do not have a defined Product CoA or Customer CoA. This is the "default" CoA.
Product CoA defines the text contents that appears on all CoAs for a specific Product Number. For example, if language different from the Facility CoA is required for a particular product, the QDMS Administrator may define text that appears on CoAs produced for a certain product.
Customer CoA defines the text contents that appears on all CoAs for a specific Product Number being shipped to a specific Customer/Location. For example, if a customer requires language different from the Facility CoA or Product CoA, the QDMS Administrator may define customer-specific text that appears only on CoAs generated for the applicable Customer.
QDMS does not automatically generate a Customer CoA for each Customer Test Plan. Customer Test Plans use the Product CoA unless a Customer CoA is created and defined.

 

 

Quality State 

QDMS provides definable Quality States that can be applied to approve or reject a lot. 
Default Quality State options:
Approved; General Use. This is the quality state assigned to all lots if all test results are in spec and Auto Approve is "on."
Approved; Restricted Use. Requires the user to enter text comments associated with the quality state which explain how the product may, or may not, be used.
Rejected. Such product requires dispositioning to define what to do with the nonconforming material in order to minimize financial loss.
Pending. May be used if, for example, re-testing is in process.

 

 

 
 
 
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