Category: QMSCAPA Update

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QMSCAPA Update QMSCAPA User Tips

QMSCAPA 2.34.2

Enhancements and Fixes

Human Resources Form

The the image above:

  • The Format Full Name [Button Control] will accurately format a persons full name regardless the presence of a Middle Name.

Linking Employee Record to the QMSCAPA System User Table

In the image above:

  1. Select Tab 7) = …
  2. Unlock Record
  3. Select Type of User as QMSCAPA System User. An Authorized Signer must be a QMSCAPA User.

Link the Unlocked System User Record

*Requires a ‘Supervisor User’ to complete this process.’

In the image below:

  1. Select Tab 6) User Profile +Login.
  2. Click on the [+ Select from User List] control button. You must be a QMSCAPA Supervisor User to execute this process.

In the image below:

  1. Create a New User or
  2. Select and existing User
  3. To confirm the correct User Login click on the [Select highlighted User Login]

In the image below:

  1. Employee Record Name.
  2. The link to Employee Record is now related to the selected User Login.
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QMSCAPA Update

QMSCAPA 2.33.1

Enhancements and Fixes

Module for Alerts, Incidents, Messages +Non-Conformance Reports (AIMNCR)

  1. Duplicate an AIMNCR record for adding/editing NC Disposition Codes
  2. Expanded the NC Disposition Code from 8 to 16 characters
  3. Lookup Customer Contracts/Orders directly from the AIMNCR form module.

Managing Training Programs, Scheduling and Training Results

The options for recording the validation of training effectiveness were expanded.

Practical Tips for establish validation methods:

  • Define Clear Objectives: Ensure training goals are specific, measurable, achievable, relevant, and time-bound (SMART).
  • Use Mixed Methods: Combine quantitative (e.g., test scores) and qualitative (e.g., demonstrations, interviews) methods for a holistic view.
  • Align with Organizational Goals: Focus on metrics that matter to the organization, like cost savings or customer retention.

Monitoring and Measuring Devices and Equipment

An Asset field [Asset Id] was added to the Monitoring & Measure Devices module.

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QMSCAPA Update QMSCAPA User Tips

QMSCAPA 2.32.1

QMSCAPA version 2.32.1 introduces important enhancements, more new reports, and direct print buttons.

Sales Quote and Contract Review

Two new direct print buttons have been added to the Sales Quote and Contract Review module to aid in the contract review requirements published of AS9100D and ISO 9001:2015 Quality Management Standards, which are paraphrased below:

AS9100D & ISO 9001:2015, Clause 8.2.3.1
The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply products and services to the customer, to include:

  • a. requirements specified by the customer, including the requirements for delivery and post-delivery activities;
  • b. requirements not stated by the customer, but necessary for the specified or intended use, when known;
  • c. requirements specified by the organization;
  • d. statutory and regulatory requirements applicable to the products and services;
  • e. contract or order requirements differing from those previously expressed.

This review shall be coordinated with applicable functions of the organization.

If upon review the organization determines that some customer requirements cannot be met or can only partially be met, the organization shall negotiate a mutually acceptable requirement with the customer.

The organization shall ensure that contract or order requirements differing from those previously defined are resolved.

The customer requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements.

Clause 8.2.3.2 The organization shall retain documented information, as applicable:

  • a. on the results of the review;
  • b. on any new requirements for the products and services.
Quote and Contract Review for AS9100D and ISO 9001:2015
QMSCAPA Contract Review module

In the image above (QMSCAPA Contract Review module:

  • a) Print Log (All);
  • b) Print Log (Sold);
  • c) Print Log (PWO) production work-order;
  • d) Print as Quote/Order with prices or without prices;
  • e) Print as Contract Review;
  • f) Print as PWO.

On-Time Delivery

The On-Time Delivery (OTD) Journal for OTD Per Shipment module was fixed and enhanced when validating “user defined” data labels and data in the form for the OTD Journal.

In AS9100D & ISO 9001:2015, Clause 8.1 Operational Planning and Control (paraphrased):

The organization shall plan, implement, and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in clause 6, by:

  • determining the resources needed to achieve conformity to the product and service requirements and to meet on-time delivery of products and services;
QMSCAPA module for monitoring On-Time Delivery (OTD)

Guidance for USING QMSCAPA Reports Used in the Management Review Process

ABCI Consultants has updated its guidance for establishing and maintaining Management Review as a process by using QMSCAPA to document the Management Review inputs, which includes a plan for how the review shall be carried out taking into consideration:

  • a. the status of actions from previous management reviews;
  • b. changes in external and internal issues that are relevant to the quality management system;
  • c. information on the performance and effectiveness of the quality management system, including
  • trends in:
    • 1) customer satisfaction and feedback from relevant interested parties;
    • 2) the extent to which quality objectives have been met;
    • 3) process performance and conformity of products and services;
    • 4) nonconformities and corrective actions;
    • 5) monitoring and measurement results;
    • 6) audit results;
    • 7) the performance of external providers;
    • 8) on-time delivery performance (AS9100D)
  • d. the adequacy of resources;
  • e. the effectiveness of actions taken to address risks and opportunities (see 6.1);
  • f. opportunities for improvement.
Guidance for USING QMSCAPA Reports Used in the Management Review Process
Download PDF

Download Guidance for USING QMSCAPA Reports Used in the Management Review Process

This ABCI guidance document refers to the following AS9100D & ISO 9001:2015 Quality Management Systems —
Requirements, beginning with Clause 9 Performance evaluation, 9.3 Management Review.

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QMSCAPA Update

QMSCAPA 2.31.14

QMSCAPA version 2.31.1 introduces important enhancements, new reports, and direct print buttons.

Additional Reports with Direct Print Buttons

Advanced CAPA Search & Report

QMSCAPA offers an advanced, user-friendly feature for searching corrective action and preventive action records. Here a six tips to get started:

  1. Start by navigating to the menu Browse Logs > Advanced CAPA Search.

2. Select the [Search] button option.

3. Enter text to search for any field of the CAPA log table.

4. Click the [Finish] button to complete the search.

5. Click on the [CAPA Tagged] print button.

6. Select an Order the the report data.

Human Resource by Department

  • Added to the Human Resource table a new direct print button and report showing the resources of a selected single Department Name.

Monitoring and Measurement Device Table

  • Added to the Monitoring and Measurement Device table a new direct print button and report showing the resources of a selected or single Location Name.
Display Screen Text Editor

Enhancements to the Display Screen Text Editor

The QMSCAPA Display Screen Text Edit (DSTE) allows an Administrator User (AU) to modify the text within the QMSCAPA program at runtime. This includes all visible text such as buttons, menu options, prompts, and window captions. The text can be altered or translated from English to any other language that uses the Latin alphabet.

This feature enables the AU to create multi-language versions of the QMSCAPA application, where users can translate the text as needed.

It also allows users to adjust terminology within the program, even if they are using the same language. This helps to make the program more familiar and user-friendly. For example, in some countries, the term “ZIP Code” is used, while in others, it is referred to as “Postal Code.” Even specific words like “color” and “colour” can have different spellings in different countries.

The DSTE allows these terms to be customized to best suit the user’s preferences.

The QMSCAPA database with the Display Screen Text is only included with the QMSCAPA ‘license-free demo.’ This demo version is used for initial installation on a stand-alone Windows computer or a multiple-user Windows OS server.

Any QMSCAPA ‘official update installers’ will not include the Display Screen Text database. QMSCAPA is shipped with a default database. Rest assured, any translations or text changes made by the AU will not be overwritten by subsequent software updates.

Passive Software Record Locks

Active Lock the Open Record

We continue to on work on improving the passive software record lock (PSRL). Typically PSRL refers to a security mechanism that automatically restricts access to certain software features or data without requiring active user intervention. This can be used to prevent unauthorized access or to ensure that only authorized users can perform specific actions within the software.

Also, we have added [Active Lock button] to many of the record editor windows. This gives users more control over when to lock records actively, complementing the passive security measures already in place.

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QMSCAPA User Tips

Approving & Verifying Documented Information

This QMSCAPA User Tip applies to the Document Control Module, and focuses on an alternate method of approving and verifying documents without using the QMSCAPA document change log and electronic approval journal.

  • Open a document control record form the Document Control Index or the Document Tree.
  • Go to Tab 2) Version Approval and History
    • #1) If any Required Approvals are checked, then uncheck these Required Approvals.
    • #2) Enter #1 into the [Verified] field.
    • #3) Check [Approval Verified] field.
    • #4) QMSCAPA will automatically place “Today’s Date” into the [Date Approved] field. Therefore, you may need to enter an appropriate [Date Approved]. Typically, the “Date Approved” should be prior to or equal to the [Effective Date] field.
    • #5) Go back to Tab 1) Document Description.
  • Return to Tab 1) Document Description
    • Check the [Use Alphanumeric] checkbox,
    • Verify the [Version Number] field version number matches the File-Naming-Convention (FNC) or by opening the document if the FNC does include the document version and effective date.
    • Verify the [Effective Date] field matches the effective date of the document attached and described in the Document Control Record.
    • Verify the contents in the [Document Status] field. If the document is approved and verified then select the appropriate Status. Example best practice, Approved, Uncontrolled when printed.
    • Select or enter the “Approved by Title” in the [Approved by Title] field.
  • Recommendation: Add a document description or purpose to the [Document Description/Purpose] field.
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QMSCAPA Update

A comparison between Windows Remote Desktop Services (RDS) and TSPLUS®:

Windows Remote Desktop Services (RDS)

Platform: Primarily Windows-based, with support for Mac and Linux via third-party solutions.

Deployment: On-premises or cloud-based via Azure.

Security: Advanced security features including SSL encryption, Network Level Authentication (NLA), and continuous access evaluation policies.

Performance: Optimized for hosting applications and desktops with RD Session Host Configuration.

Management: Integrated with Active Directory for user and group management, and enhanced RD Licensing Management.

Pricing: Typically part of a Windows Server license, with additional CALs required.

TSPLUS®

Platform: Supports Windows 10, 11, Windows Server, Mac, Linux, SaaS, and Web-based solutions.

Deployment: On-premises or cloud-based, with a focus on ease of deployment.

Security: Offers SSL encryption and smart card authentication for secure remote access.

Performance: Known for its ease of use and quick setup, making it suitable for small to medium-sized businesses.

Management: Provides centralized management for remote access, application delivery, and remote printing.

Key Differences

Platform Support: TSPLUS offers broader platform support compared to RDS.

Deployment Flexibility: TSPLUS is often praised for its ease of deployment and setup.

Security Features: Both offer robust security features, but RDS has more advanced options integrated with Windows Server.

Management Tools: RDS is deeply integrated with Windows Server management tools, while TSPLUS offers a more streamlined approach.

Ultimately, the choice between RDS and TSPLUS depends on your specific needs, such as platform requirements, deployment preferences, and budget.

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QMSCAPA User Tips

Statistical Process Control (SPC)

Statistical Process Control (SPC) is a method used in QMSCAPA software, among other Quality Management Systems, to monitor and control a process through statistical analysis. Here are some basic SPC tools and techniques found in QMSCAPA:

  1. Control Charts: These charts help monitor process performance over time and identify variations. They distinguish between common cause variation (inherent to the process) and special cause variation (due to external factors).
  2. Pareto Charts: These charts identify and prioritize the most significant factors in a process, helping to focus improvement efforts on the most impactful areas.
  3. Histograms: These are bar charts that show the distribution of data, helping to understand the variation within a process.
  4. Scatter Diagrams: These diagrams show the relationship between two variables, helping to identify correlations and potential causes of variation.
  5. Cause-and-Effect Diagrams (Fault-Tree Diagrams): These diagrams help identify potential causes of a problem, organizing them into categories for easier analysis.
  6. Check List/Sheets: These are simple forms used to collect and analyze data, often used for tracking defects or occurrences.

By using these tools, organizations can detect issues early, improve process stability, and enhance overall quality.

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QMSCAPA User Tips

Customer Feedback

Including Customer Complaints

QMSCAPA, access to the Customer Feebdack module

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QMSCAPA Update

QMSCAPA 2.26.7

Recording Non-Conformance Linked to Quality Objectives and Other KPIs

QMSCAPA software can be used for recording non-conformances. It includes a module specifically for logging non-conformances, allowing you to track and address quality issues within your organization.

Alert Incident Message

Non-Conformance Form

In AS9100D and ISO 9001:2015, the process approach plays a crucial role.

Let’s break it down:

  1. Internal Processes:
    • These are the activities within an organization that contribute to achieving its objectives.
    • They involve a set of interrelated or interacting activities that use inputs (which can be tangible or intangible) to deliver an intended result.
    • Examples include production, quality control, and management processes.
    • The process approach emphasizes integration and systematic management of these internal processes.
  2. External Processes:
    • These are processes that interact with the organization from outside.
    • They may include suppliers, partners, or other external stakeholders.
    • ISO 9001:2015 also considers external issues that affect the organization (e.g., market trends, legal requirements).
    • Addressing external processes ensures the organization’s QMS is adaptable and responsive to the external business environment.

Remember, the process approach involves risk-based thinking and follows the PDCA cycle (Plan-Do-Check-Act) for continual improvement.

The QMSCAPA software module for Nonconformance and Corrective Action provides direct links to the following Quality Management Systems methods and processes:

  • Customer feedback, including complaints.
  • Corrective Actions, including “root cause analysis” with a “5 Why” and “Fault Tree” tools.
  • Quality Objectives and Key Performance Indicators
    • On-time delivery
    • Product Acceptance
    • Supplier Performance
    • Sales Order and Contract Reviews
    • Supplier Performance

Quality Measurement Tools in QMSCAPA

These tools include direct links to the AIM Nonconformance Log.

  1. Key Performance Indicators (KPI) for monitoring in-process inspections and final inspections.
  2. Manufacturing and/or production Quality Metrics.
  3. On-time delivery monitoring.
  4. Purchasing (Supplier performance) Quality Metrics.
  5. Sales Quotes, Orders and Contract Review processes.
Categories
QMSCAPA Update

QMSCAPA Contract Review Module

QMSCAPA provides a robust module, method and process for meeting the requirements of ISO 9001 and AS9100, among others, which focuses on Clause 8 Operations:

  • 8.1     Operational Planning and Control
  • 8.2     Requirements for Products and Services
    • 8.2.1 Customer Communication
    • 8.2.3 Review of the Requirements for Products and Services
    • 8.2.4 Changes to Requirements for Products and Services
QMSCAPA ISO 9001 & AS9100 Review of the Requirements for Products and Services

Sales Contracts, Proposals, and Quotes are directly linked to the Customer module.

The Sales Contract and Quote Table may be used to log the Operation Planning and Controls.

Use the Contract Review module for creating and maintaining documented information

  • Sales Quotes and Contracts
  • requirements specified by the customer, including the requirements for delivery and post-delivery activities;
  • requirements not stated by the customer, but necessary for the specified or intended use, when known;
  • requirements specified by the organization;
  • statutory and regulatory requirements applicable to the products and services;
  • contract or order requirements differing from those previously expressed.
Contracts, Quotes, and Proposal can copied and modified.
Sales Contracts, Proposals, and Quotes may be created, copied and reassigned to other Customer Records.
Assigning a Quote/Contract review to another Customer record.
These Contract reviews shall be coordinated with applicable functions of the organization.
  • If upon review the organization determines that some customer requirements cannot be met or can only partially be met, the organization shall negotiate a mutually acceptable requirement with the customer.
  • The organization shall ensure that contract or order requirements differing from those previously defined are resolved.
  • The customer requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements.
  • 8.2.3.2 The organization shall retain documented information, as applicable:
    • on the results of the review;
    • on any new requirements for the products and services.
  • 8.2.4 Changes to Requirements for Products and Services
    • The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed.