10-Steps to Better Quality Management in the Manufacturing Sector

Different Quality Standards in the Manufacturing Industry

One of the essential quality standards for the manufacturing industry is ISO 9001. However, other industry-specific standards exist, such as AS9100 for aerospace, ISO 13485 for medical device manufacturing, etc.

ISO 9001

Considered one of the most important updates of ISO 9001, ISO 9001:2015 has a direct impact on every industry and its standards. The new updated version of ISO 9001 takes a new approach by allowing organizations to design their quality management systems based on the industry in which they operate. The new standard emphasizes risk-based thinking to create a process approach and insists that leadership take a more active role in quality.

ISO 14001

Created as a framework for better management control that can reduce environmental impacts, ISO 14001 pertains to all industries, including General Manufacturing, Consumer Packaged Goods, Aerospace and Defense, Hi-Tech, Automotive, and Life Sciences. The primary aim of ISO 14001 is to assist companies in continually improving their environmental performance while complying with applicable legislation. ISO 14001 can also be integrated with other management functions and helps companies meet their environmental and economic goals.

ISO 13485

ISO 13485:2016 has become the new medical device quality systems foundation. ISO 13485 certification communicates a quality commitment to both customers and regulators. It allows increased access to more markets worldwide, provides a mechanism to review processes across the organization for continuous improvement, and can increase efficiency, cut costs, and improve supply chain performance. If you haven’t started your gap analysis, the time to start that transition is now.

IATF 16949

IATF 16949 replaced ISO/TS 16949:2009. IATF 16949 defines the QMS requirements for the design and development, production, and, when relevant, installation and service of automotive-related products. IATF 16949 applies to sites of the organization where customer-specified parts for production and/or service are manufactured.

AS 9100

The aerospace industry is highly globalized. Despite sourcing components from suppliers worldwide, OEMs must ensure the quality of the end product. Every company in the industry must meet national regulations and standards. The ISO standard applicable to the aerospace industry is AS 9110. AS 9100 defines additional areas within an aerospace QMS that must be addressed when implementing an ISO 9001-based quality system. These requirements ensure product, process, and service safety and quality.

6 Possible Quality Issues in the Manufacturing Sector

Quality Issue #1 – Lack of standardized SOPs can affect the quality-first approach as employees do not have the proper training and understanding of quality objectives, raw material consumption, and shop floor processes within the organization. This results in unpredictable output.

Quality Issue #2 – Siloed approach to quality assurance creates barriers that affect the ability to consolidate quality control data. Due to the absence of an integrated workflow among departments, businesses are left with multiple quality metrics and processes with conflicting goals.

Quality Issue #3 – Inefficient supplier quality management affects visibility and results in high non-compliance costs that can directly impact the product’s quality.

Quality Issue #4 – Inadequacies in equipment management processes directly impact output, increasing time-to-market, product defects, and production costs.

Quality Issue #5 – High cost of quality (CoQ) or the cost of poor quality (COPQ) affects the overall CoQ of the organization, as a high CoQ is associated with poor quality, scrap cost, or customer complaints.

Quality Issue #6 – Manual training using paper-based training can result in poor-quality training, resulting in product quality decline, increased manufacturing cost, and raw material wastage as there is no process consistency.

How can Companies in the Manufacturing Sector Create a Culture of Quality?

Continuous Quality improvement is essential to running a lean and productive enterprise. Following traditional methodologies and tools will not be a practical solution anymore. Achieving a sustained quality culture will allow organizations to flourish through good times and tough times. Organizations can use principles, including the Six Sigma quality initiative, to change the company’s DNA to create a quality culture. To track the quality of Six Sigma, companies can use the following five parameters –

• Customer satisfaction
• Cost of poor quality
• Supplier quality
• Internal performance
• Design for manufacturability

Role of AI in Quality Management

Artificial Intelligence (AI) and Machine Learning (ML) techniques are now gaining popularity in the area of quality management. Businesses across industries leverage AI to take their quality management efforts to the next level. AI in Quality Management is used in eleven different areas – compliant management, CAPA effectiveness, risk mitigation, management review, training talent and skilling, audits, post-market surveillance, SOP development/automation, proactive customer service, design for quality, and process improvement.

Why Should Companies Focus on Quality Risk Management?

Quality risks are part of all industries, processes, and departments. To that end, every organization must focus on creating robust risk management processes and impart risk-based thinking to product failures, financial penalities, and quality issues. Businesses in the manufacturing sector must look at quality risk management as a continuous process that facilitates risk managers to analyze risks and develop strategies to control future outcomes by taking proactive measures. It helps identify exisiting risks, analyze the potential risks, prioritize the risk based on severity, implemente a solution, and continuously monitor the risk. Effective risk management allows risk managers to reduce repetitive losses and maximize project success by analyzing risk patterns.

What are Some of the Best Practices for Better Quality Management in the Manufacturing Sector?

Some of the Best Practices For Implementing Quality Management are listed below.

• Documentation – Define and enforce standard quality guidelines for quality measures. Following this will be thorough documentation of quality measures and metrics.
• Stakeholders Participation – Involve stakeholders in identifying and defining quality standards. Align these quality standards with the organization’s goals and initiatives to ensure the business can gain the management’s commitment to focus on quality at an enterprise level.
• Data Automation – Automate quality data collection using a dashboard that offers a 360-degree view. Get feedback on quality metrics and proposed measures from within the organization, customers, and other stakeholders.
• Quality Performance Targets – Allow business unit leaders to establish performance targets for quality measures and report quality-related data. Implement a proactive approach for addressing quality issues instead of a reactive approach.
• Customer Expectations – Refocus quality measures to meet customer expectations throughout the value chain and not just during delivery. Conduct continuous quality management processes throughout the lifecycle.
• Quality Metrics – Track quality metrics and measures to understand the trend, improve or modify quality standards, and remain compliant.
• Quality Ownership – Assign an individual as the owner of the quality function to help establish a strong quality group with clear responsibilities, authority, and resources to monitor quality activities within the organization. Periodically review quality standards and metrics.
• Standardize Tools for Analysis – Quality experts and managers must focus on quality by creating standardized tools that help conduct detailed analysis and reporting to achieve continuous improvement. Establish thresholds that can be used to define CAPA.
• Quality Analysis – Analyze quality impact across the industry, including product, finance, customer service, and suppliers management.
• Training – Train all new employees on basic quality management principles while providing transparent access to quality data to everyone within the organization. Constantly look to improve quality.

How can QMS Software Help with Quality Management in an Organization?

CQ Manufacturing QMS Quality Management System allows businesses to evolve from a reactive approach to quality events to adopting a more predictive and proactive quality management approach. The QMS in Manufacturing converts data into intelligence and actionable insights for the management. CQ Quality Management has a proven record to

• accelerate product innovation
• meet regulatory requirements
• speed to market and operational excellence
• improving customer satisfaction

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