Bluestreak™ Reading Time: 6 minutes
su•per•fi•ci•al•i•ty (Part Three)
Simplified QMS Software can Lead to Inadequate Outcomes
with Notable Downsides.
Employee Accountability and Tracking
Incomplete records of who operated what equipment and when they did it can fail an audit.
Tracking and documenting employee accountability is important, particularly when operating equipment or requiring certification. This capability ensures that only qualified personnel handle specific tasks and machinery, which is critical for maintaining operational safety and product quality. Documenting these details supports compliance with industry regulations and standards, and it enhances overall process integrity by ensuring that all actions are traceable.
For a heat treater, tracking and documenting employee accountability when operating equipment or requiring certification is crucial for several reasons:
• Safety and Compliance: Heat treating involves high temperatures and potentially hazardous materials. Ensuring that only certified employees operate such equipment is essential for maintaining safety standards and complying with occupational health and safety regulations.
• Quality Control: The quality of heat-treated products depends heavily on precise temperature management and timing. Documenting who performed specific tasks helps trace any issues in the final product back to its source, facilitating quick corrective actions.
• Training and Certification Tracking: In heat treating, specific certifications may be required to handle certain materials or equipment. A robust QMS ensures that all operators are up-to-date with their certifications and have the necessary skills, which is vital for both regulatory compliance and maintaining high standards of product quality.
• Audit Readiness: Detailed records of who operated what equipment and when they did it are invaluable during audits. This documentation demonstrates that the company adheres to the required standards and practices, helping to pass audits more smoothly.
• ITAR/EAR Viewer Restriction Tracking: Internal corporate policy on user viewing restrictions ensuring that only authorized users handle critical defense-related technologies and information.
ITAR/EAR Viewing Restrictions
Companies or manufacturers that produce, design, and distribute military and defense-related equipment and services or deal with dual-use technologies, goods, software, and technology used for both civilian and military applications, have stringent management requirements regarding the various user viewing restrictions and regulations. Aerospace, defense contracting, and high-technology sectors are common examples where adherence to ITAR/EAR is crucial due to the sensitive nature of their products and technologies.
It is the manufacturer's responsibility to ensure their supply chain is appropriately certified and compliant with ITAR/EAR Regulations. Non-compliance could result in substantial penalties, both civil and criminal, so choosing a sophisticated QMS is essential for adhering to this regulatory framework.
ITAR (International Traffic in Arms Regulations) and EAR (Export Administration
Regulations) are U.S. regulatory frameworks designed to control the export and import of defense-related articles and services on the United States Munitions List (USML) and dual-use technologies on the Commerce Control List (CCL), respectively. ITAR is administered by the U.S. Department of State's Directorate of Defense Trade Controls, while EAR is governed by the U.S. Department of Commerce's Bureau of Industry and Security. These regulations ensure that sensitive technologies and information do not fall into the hands of entities that may pose a threat to national security.
The Human Factor-Clarifying Employee Accountability (Taking shortcuts highlights the critical need for accountability)
Since individual people are involved in completing every part of a job properly, their desire to speed up processing and cut as many corners as possible to meet their assigned production quotas SCREAMS for continuous accountability. Without it, quality will suffer dramatically, rework and production costs will increase, unhappy customers and fewer orders will follow, and profits will plunge. Your ultimate business goal will not come to fruition.
These shortcuts may:
• Claim to have completed a task that was left undone.
• Attempt to skip a crucial step in the operational process.
• Falsely sign off on a process, asserting it was checked and verified when it was not.
• Assert that a part was meticulously inspected for defects when, in reality, the inspection was superficial.
• Allow unqualified operators to use equipment.
The QMS should gather all required information electronically, ensuring clarity on how each job step was processed, completed and done by whom. This includes obtaining the appropriate sign-offs and generating automatic compliance assurance documentation as the job progresses through the production floor toward completion.
Some software solutions boast of saving time by automatically tracking multiple job steps simultaneously. However, this can lead to quality management failures due to a lack of accountability for those processing steps. If individual job steps weren't important, why were they included in the original process?
Automatic job-step tracking assumes:
Every step is completed correctly without verification, and no deviations occur that could compromise quality.
This approach compromises quality management by neglecting critical checkpoints:
• The same individual carried out the omitted job steps.
• It is assumed that the workforce and production operators adhered flawlessly to both customer and internal specifications.
• The person conducting the work had the qualifications for that specific job step or to operate that equipment.
• The equipment used was appropriate and qualified for the task.
• All test results and quality inspections fell within acceptable limits.
• There were no non-conformities linked to the job steps that were aut
automatically advanced.
• The equipment and personnel operated without any issues that could impact the quality or outcome of the job.
• No parts were damaged during the production step.
• The bypassed step fully complied with job requirements.
• A CAPA was not needed because it was assumed that all necessary corrective and preventive actions were effectively implemented and checked.
• The time taken for each job step was deemed unnecessary information.
Poorly Defined Processes
Insufficient process documentation often results in nonconformities and adverse audit outcomes.
Poorly defined processes are a significant source of nonconformities and negative audit findings, primarily because they lead to inconsistent production outcomes and inadequate evidence of compliance. When processes are not clearly outlined, workers may not have a uniform understanding of the necessary steps or quality standards required, resulting in products that do not meet specifications or customer expectations. For instance, if a metal fabrication company lacks precise guidelines for the welding process, variations in welding techniques among workers could lead to structural weaknesses in the finished products. This inconsistency often becomes apparent during quality audits when there is no clear documentation or evidence to show that all products are manufactured to the same standard.
Furthermore, poorly defined processes complicate the collection and presentation of evidence during audits. Auditors require clear and concrete proof that each step of the process adheres to predefined standards and regulations. Without detailed process definitions, it becomes challenging to demonstrate that operations were conducted correctly.
In most manufacturing, if the process is not meticulously defined and followed, it could not only lead to safety risks but also result in audit failures when the auditor cannot find sufficient evidence that each component was completed correctly. This lack of detailed process definitions can lead to significant repercussions, such as the need for costly rework, recalls, or penalties for non-compliance. Additionally, it can damage a manufacturer’s reputation and lead to a loss of trust among clients and regulatory bodies, ultimately impacting the company's ability to secure future business.
Poor Integration with ERP System
Technical and operational challenges are causing an incompatible interface with the existing ERP system.
Limited software system integration, particularly when a simplistic QMS fails to effectively connect with an Enterprise Resource Planning (ERP) system, results in significant communication barriers across production floor departments. This issue can arise due to several technical reasons:
• Incompatible Data Formats: One of the primary technical challenges is that different systems often use incompatible data formats. A simplistic QMS might not be designed to handle the complex data structures or formats used by modern ERP systems. This incompatibility prevents the seamless flow of data, as information cannot be directly transferred or may require manual conversion, which is time-consuming and error-prone.
• Lack of API Integration: Modern ERP systems are typically equipped with Application Programming Interfaces (APIs) that allow for integration with other software tools. If a QMS cannot integrate via APIs, it cannot connect effectively with the ERP system. Simplistic QMS solutions may not have the necessary API support or outdated APIs that do not match the modern, more secure, and robust APIs of current ERP systems.
• Outdated Technology Stack: QMS solutions may be built on older technology stacks that do not support the latest integration protocols and security measures. This outdated technology can limit the system’s ability to interface with newer ERP systems that use advanced technologies for data exchange and security.
• Limited Customization and Scalability: Limited customization options make it difficult to tailor the QMS to meet the specific integration needs of an ERP system and the growing data requirements of an organization, leading to performance bottlenecks, especially when trying to process and share large volumes of floor data across departments.
• Poor Security Measures: Effective integration also requires robust security protocols to protect the data exchanged between systems. QMS solutions may lack advanced security features like encryption, secure data transfer protocols, and authentication mechanisms, increasing the risk of data breaches during the integration process.
Conclusion Ensuring robust employee accountability and adherence to ITAR/EAR regulations are critical for maintaining quality, safety, and compliance in specialized industries like heat treatment. Simplified QMS software often falls short, leading to severe consequences, including audit failures, safety risks, and regulatory penalties. For a comprehensive understanding of the potential pitfalls and to ensure your operations are audit-ready and secure, stay tuned for part four of this series, where we delve deeper into these challenges and solutions.
Author: Ron Belts, Director Of Strategic Accounts for Bluesteak | Bright AM™
About Bluestreak™:
Bluestreak™ is a fully integrated Quality Management System (QMS), a powerful Manufacturing Execution System (MES) designed for the manufacturing environment and service-based manufacturing companies ( metal-treating/powder-coating, plating, heat-treating, forging, and metal-finishing), businesses that receive customers’ parts, perform a process (service) on them, and send those parts back to the customer). Companies need MES software tailored to specific functionality and workflow needs, such as industry-specific specifications management, intuitive scheduling control for staff and machinery maintenance, and the ability to manage work orders and track real-time data. If different work centers on the production floor aren’t “speaking” to each other via the MES, the data loses value and becomes disjointed or lost in disparate silos.
Bluestreak | Bright AM™ is an MES + QMS software solution specifically designed to manage and optimize the unique requirements of Additive Manufacturing’s production of parts and powder inventory usage.
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