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.

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.

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

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

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.

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.

We have completed many improvements for QMSCAPA to provide better performance when running inside a Windows Server with TSPLUS.

TSPLUS provides Remote Desktop Services through a secure connection with many modern browsers, including Google Chrome, Microsoft Edge, and Mozilla Firefox.

In addition to supporting multiple-concurrent users and multiple tenants in a Microsoft Remote Desktop Server, QMSCAPA may be deployed using a Microsoft Server (2016R and higher) configured with TSPLUS.

This configuration provides a very high performance and stable working environment through the HTML5 architecture that works in all modern browsers.

A factor in problem solving is considered a ROOT cause if removal thereof from the problem-fault-sequence prevents the final undesirable event from recurring.

Whereas a CAUSUAL factor is one that affects an event’s outcome, but is not a root cause. Though removing a CAUSUAL factor can benefit an outcome, it does not prevent its recurrence within certainty.

The concept emphasizes the importance of digging deep to identify the fundamental issues in a problem-fault sequence. By addressing the root cause, we aim to create lasting solutions, while managing causal factors may offer only short-term relief or limited improvement.

The challenge often lies in accurately identifying root causes versus causal factors, as they can sometimes blur together amidst complexity. These principles particularly may be useful in a specific field or situation, like engineering, business, or troubleshooting.

Root Cause Analysis Tools in QMSCAPA

QMSCAPA software incorporates two root-cause analysis methods and tools for problem-solving: the ‘Fault-Tree’ method and the ‘Five-Why’ technique.

These tools are integrated with the Corrective Action and Preventive Action module.

Enhancements

Important enhancements and fixes have been made in a new release of QMSCAPA™ (version 2.22.1) and is available for download from QMSCAPA.app.

Quality Monitoring and Measurements

All of the Quality Monitoring and Measurements modules, browse tables and forms have been overhauled to simplify and streamline the entry and maintenance processes.

• Customer Satisfaction Surveys based upon the “Ten Squared” method, which includes a criteria of 10 evaluated on a scale of 1 to 10.
• Key Performance Indicators for generic processes that can be applied to virtually any process.
• Manufacturing and Production Quality Measurements.
• On-time Delivery and Shipping Monitoring.
• Purchasing Quality Measurements.
• Monitoring for Sales and Contract Review Processes.
• Quality Performance Dashboard for monitoring all Quality Objectives and other processes.
• Supplier or Vendor Evaluations, based upon the “Ten Squared” method, which includes a criteria of 10 evaluated on a scale of 1 to 10.

Customer Satisfaction Survey Question Sets

1. On the tab 1) General – Questions 1 through 10 establish the survey focus and questions. The ‘Quantity of Questions to Use’ appears on the tab 2) Focus or Purpose of the Survey. This value can be from 1 to 10.
2. Set the highest value for the criterion score. This value can be from 1 to 10.

Customer Satisfaction Surveys and Results

1. Select from 1 to 9999 Survey Sets, all user defined.
2. Send a Customer Satisfaction Survey as a PDF or RTF document.

Key Performance Indicators

This generic measuring module may be applied to any process that should be monitor by key performance indicators (KPI).

1. Select from 1 to 9999 Label Sets, all user defined. The Label Set is used to store information about what should be monitored and measured, which includes:
   • Label Set name.
   • A description of the methods of monitoring to be applied.
2. The process to be monitor.
   • The frequency of monitoring, and/or accumulation of information.
   • An option to identify a product or service identifier.
3. Label Options:
   • Label #1 is the Gross Amount Value of the process execution or production.
     • Label #2 is a value a defect or nonconformance that is subtracted from the Gross Amount; example, an internal issue.
     • Label #3 is a value a defect or nonconformance that is subtracted from the Gross Amount; example, an external issue.
     • Label #4 is a value a defect or nonconformance that is subtracted from the Gross Amount; example, a specific issue.
       • Optionally, the values of Label 2, 3, and 4 may be used to “add to the Gross Amount”; example, in process corrections or rework that may have occurred during they same data accumulation period (shift, day, batch, etc.)

Manufacturing/Production (Product Acceptance/Conformity)

1. Select from 1 to 9999 Labels Sets, all user defined.
2. Select a Product/Service monitored.
3. The Label Set defines the focus of the issues measured.

On-time Delivery

1. Select a formula for the determining “on-time delivery”.
   • SBD vs ASD Formula
     • SBD (Ship by Date), is the date promised to the customer for the outbound shipping process.
     • ASD (Actual Ship Date), is the date of the actual shipping date to the customer.
   • CDD vs ARD Formula
     • CDD (Customer Due Date), also referred as the “Customer Dock Date”, is a customer requirement.
     • ARD (Actual Received Date), is the date the “customer actually received the product/service ordered”.
2. Date of the Order.
3. Ship by Date.
   • Actual Ship Date
   • Customer Due Date
   • Actual Received Date
4. Early, On-time, and Late shipments are calculated.

Purchasing/Supplier Performance

1. Select from 1 to 9999 Labels Sets, all user defined.
2. Select a Supplier/Vendor monitored.
3. The Label Set defines the focus of the issues measured.

Root Cause Analysis

The QMSCAPA “Fault Tree Analysis” tool is built right inside the QMSCAPA software module for Corrective Actions.

• The main “Problem” in the CAPA record becomes the main event at the top of the diagram or worksheet to be developed.
• One or more team members can login to QMSCAPA to record thoughts and ideas about what may have contributed to the problem.
• The first-level of causes above the main event form the fault tree Aspects branches.
• Within each “Aspect branch” one or issues may identify more specific issues that contribute to the “the “Problem” as a percentage of the total contribution.
• These “aspect issues” become the “Aspect Issues branches” at the different aspect or causes to determine whether it is a basic cause or the result of underlying causes.
• As underlying causes are identified, record the theoretical probability of the “aspect issue branch” as a percentage of the cause.
• The “total percentage” from all “aspect issues” should always be 100% when the root cause analysis is completed.

Sales and Customer Related

1. Select from 1 to 9999 Labels Sets, all user defined.
2. Select a Contract or Sales Order Id.
3. The Label Set defines the focus of the issues measured.

Supplier/Vendor Evaluations

Supplier or Vendor Evaluations, based upon the “Ten Squared” method, which includes a criteria of 10 evaluated on a scale of 1 to 10.

1. Select from 1 to 9999 Labels Sets, all user defined.
2. Select a Supplier/Vendor Id.
3. The Label Set defines the focus or criteria evaluated.

Fixes

Purchasing Processes

The Purchasing Processes module provides a method for managing purchasing transactions, which incudes:

1. Request for Quotes (RFQ) sent to suppliers;
2. Internal request for Request for Purchase Orders (RFPO);
3. Purchase Orders issued to suppliers;
4. Receiving and Inspection Reports.

In the imagine above:

1. Use the button [Apply the Transaction Id to the Reference Id] to copy the Transaction Id to the Reference Id field.
2. Use the button [Apply Date + Time to Reference Id] to the Reference Id field as “Reference Id:#YYMMDD-HHMMSS”.
3. The button [Ship Via Id] allow the user to lookup and select the shipping company and/or add more shipping companies.

Important additions, enhancements and fixes have been made in a new release of QMSCAPA™ (version 2.18.10) and is available for download from QMSCAPA.app.

Added New Features

• New Reports for the Purchasing Processes module
• New ‘copy a record‘ feature for the Purchasing Transactions [Requested by User Group].

Enhancements

Human Resources module

• Human Resource module, added Employee “hire date” and “end date”. [Requested by User Group].

Process Key Performance Monitoring

• Key Performance Indicator (KPI) table and reports; Added a “Bi-Annual Record Type” to the Label Set for monitoring and measurements of process. [Requested by User Group].

Supplier / Vendor Evaluation module

1. Table showing Suppliers and Vendors
2. Table showing evaluations for the supplier Chevrolet
3. Reports for Suppliers and Evaluations

Fixes

• KPI Report for (All).

• HR Reporting by Department, updated the header records.

1. Report a Human Resource (HR) record for the selected person.
2. Report all active HR.
3. Report all HR by Department order.
4. Report HR “authorized permission” for the selected person, including:
   1. Environment
   2. Health & Safety
   3. Information Security
   4. Location
5. Report Training completed by HR.
6. Report Training completed for the selected Resource.

Important additions, enhancements and fixes have been made in a new release of QMSCAPA™ (version 2.17) and is available for download from QMSCAPA.app.

Added New Features

• A Controlled Document Table has been linked to the Process Description.
• Added three new Process Maps for Process Planning and Auditing.

• 1) The window tab row includes access to the Process Activities;
• 2) The Sources of Input;
• 3) Input +Documents, including a Primary Document and;
• 4) Any other additional documents can added to the table.

Enhancements

• Enhanced the Training Program elements (syllabus) table by adding a lookup table of commonly used syllabus elements.

Fixes

• Primary Document link from the Training Program to the Controlled Document Table.

Process Planning Module

In the ISO 9001:2015 International Standard, among other (Aerospace, Automotive, and ISO) Standards, promotes the adoption of a process approach when developing, implementing, and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.

Specific requirements considered essential to the adoption of a process approach are included in ISO 9001:2015, section 4.4. Understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its intended results.

This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced.

Also, the process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization.

The application of the process approach in a quality management system enables:

• understanding and consistency in meeting requirements;
• the consideration of processes in terms of added value;
• the achievement of effective process performance;
• improvement of processes based on evaluation of data and information.

In the image above:

1. Show the QMSCAPA Process Table list.
2. The Process Named ‘Customer Service’ is open in the Process & Subprocess Window.
3. Process & Subprocess Window contains seven tabbed sections, which are:
   1. Process Activity;
   2. Sources of Input;
   3. Input, plus a table with controlled documented information;
   4. Output;
   5. Receivers of Output;
   6. Sub-processes (table of subprocess)
   7. Related Clauses from a Management System Standard, (e.g., ISO 9001:2015).

Sources of Input, Input and Documented Information

Output, and Receivers of Output

Subprocess

Standard Clauses related to the Process Plan

Process Planning Report

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Important additions, enhancements and fixes have been made in a new release of QMSCAPA™ (version 2.16.12) and is available for download from QMSCAPA.app.

Added New Features

• Training Program Documents Report, which list all documents and materials that are associated with a Training Program.

Enhancements

• 8D window form and layout
• Corrective Action Reports
• Integration with Microsoft Office,
  • including Excel, Word, Outlook 
• Import from Excel for External Monitoring
• Print Documentation Manual (Plan for QMS) from the Document Control Index; selected by Department or Standard.
• Printer & Report Previewer
• Process Key Performance Indicator (KPI) Reporting
• Risk and Opportunity assessments for relevant interested parties
• Training Scheduled and Completed Reports
• User-defined Guidance

Fixes

• Customer Satisfaction trend report
• On-time Shipping trend report
• Relevant Interested Parties (All) report

Changing Window Text

AnyText allows a user to change the text in a QMSCAPA Window at runtime. Most of the visible text, including Window Captions, Prompts, Buttons and so on can be translated.

This allows a Supervisor User to create multi-language or special vernacular versions of QMSCAPA application.

It also allows users to change terminology inside a program, even if they are using the same language. This helps to make the program more familiar to users. For example in some countries you would use a ZIP CODE in an address, whereas in others this is known as a POSTAL CODE.

Printing a Document or Manual from the Document Control Index (DCI)

The Default Document/Manual report template was updated to include more “user-defined” information, which may appear inside the DCI and any document grouped defined by a user, such as by category, type, and standard.

• Print a “Manual” from the Document Control Index (DCI) or Document Tree

• [A] Select a “group” of documents by a category (Quality Management, Safety Manual, etc.) or Management System Standard (ISO 9001, ISO 14001, ISO 27001, etc.)
• [B] All of the information recorded in the DCI may be reported in the document generated.
• [C] A Global Unique Indentifier (GUID) may be assigned to each document generated and, or printed. Also, the user may create a version identifier.
• [D] Print/report the Document Tree as a “manual”.

• [1] The document identifier, and title appear as a document section or chapter.
• [2] The document “hyperlinks” appear inside the manual and may remain active when printed or saved with a compatible PDF software application like Adobe Acrobat and others.
• [3] Optionally, the version and approval history may be included.

Updated the Monitoring and Measurement Device Module

• Enhance the Calibration and Maintenance Journal.
• Improved the User-defined Date control and comments field, which are also available on the report templates.
• Enhanced the equipment and machinery reports.

Added New Features

• Training Program Documents Report, which list all documents that are associated with a Training Program.

Enhancements

• 8D window form and layout
• Corrective Action Reports
• Integration with Microsoft Office,
  • including Excel, Word, Outlook 
• Import from Excel for External Monitoring
• Print Documentation Manual (Plan for QMS) from the Document Control Index; selected by Department or Standard.
• Printer & Report Previewer
• Process Key Performance Indicator (KPI) Reporting
• Risk and Opportunity assessments for relevant interested parties
• Training Scheduled and Completed Reports
• User-defined Guidance

Fixes

• Customer Satisfaction trend report
• On-time Shipping trend report
• Relevant Interested Parties (All) report