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What are the best practices for integrating ISO 9001 and risk management into your manufacturing operations?

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If you are a database administrator (DBA) in a manufacturing company, you may face various challenges related to quality, efficiency, and security of your data and processes. One way to address these challenges is to integrate ISO 9001 and risk management into your operations. ISO 9001 is an international standard for quality management systems (QMS) that helps you meet customer and regulatory requirements. Risk management is a systematic approach to identifying, analyzing, and mitigating potential threats and opportunities that may affect your objectives. In this article, you will learn some of the best practices for integrating ISO 9001 and risk management into your manufacturing operations, and how they can benefit your DBA role.

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Federico C. Banaga, Jr.

Food Safety/Quality Compliance Supervisor @ Del Monte | Lead Auditor

1 Align your QMS and risk management objectives

One of the first steps to integrate ISO 9001 and risk management into your manufacturing operations is to align your QMS and risk management objectives with your business strategy and vision. This will help you ensure that your data and processes support your organizational goals and values, and that you have a clear direction and scope for your integration efforts. You can use tools such as SWOT analysis, SMART goals, and balanced scorecard to define and communicate your objectives across your organization.

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Federico C. Banaga, Jr.

Food Safety/Quality Compliance Supervisor @ Del Monte | Lead Auditor
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There are several ISO standards and international guidance documents that provide direction and lay out the framework for successfully implementing and sustaining an effective and robust quality management system regardless of its type or size, or the products and services it provides, with integration of risk-based thinking. It is becoming evident that quality risk management is a valuable component of an effective quality system. Quality risk management supports a scientific and practical approach to decision making. It provides documented, transparent and reproducible methods to accomplish steps of the quality risk management process based on current knowledge about assessing the probability, severity, and sometimes detectability.

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2 Conduct a risk assessment and analysis

Another important step to integrate ISO 9001 and risk management into your manufacturing operations is to conduct a risk assessment and analysis of your data and processes. This will help you identify the sources, causes, and consequences of potential risks, as well as the likelihood and impact of each risk. You can use tools such as risk matrix, risk register, and risk map to prioritize and categorize your risks based on their severity and urgency. You should also consider the opportunities that may arise from your risks, and how you can exploit them to improve your performance and competitiveness.

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Federico C. Banaga, Jr.

Food Safety/Quality Compliance Supervisor @ Del Monte | Lead Auditor
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One thing I've found helpful is to make reference with the International Conference on Harmonization (ICH) Quality Risk Management Guidance for Industry. The ICH QRM guidance provides a quality risk management process. The model is comprised of three primary areas — risk assessment, risk control, and risk review — contained in a framework of using risk management tools and risk communications.

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3 Implement risk controls and mitigation strategies

Once you have identified and analyzed your risks, you need to implement risk controls and mitigation strategies to reduce or eliminate their negative effects on your data and processes. This may involve modifying your database design, configuration, and maintenance, as well as implementing security measures such as encryption, authentication, and backup. You should also document your risk controls and mitigation strategies, and assign roles and responsibilities for their execution and monitoring. You can use tools such as action plan, checklist, and flowchart to organize and track your implementation activities.

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Federico C. Banaga, Jr.

Food Safety/Quality Compliance Supervisor @ Del Monte | Lead Auditor
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Here are several tools we used in the company for a systematic approach to risk and opportunities: 1. Brainstorming to determine the issues relevant to the company. It involves a team that generate ideas without consideration for whether the idea is good or bad. 2. SWOT Analysis - can be used for short-term tactical planning such as processes and systems, and for long-term strategic organizational planning. 3. PESTEL Analysis - a planning tool that is like the SWOT analysis but is more focused on long-term strategic organizational planning. These are just some of the tools to aid the process of integrating risk management throughout the QMS. There are many more tools available to identify and analyze risk such as FMEA and HACCP.

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4 Monitor and review your QMS and risk management performance

The final step to integrate ISO 9001 and risk management into your manufacturing operations is to monitor and review your QMS and risk management performance on a regular basis. This will help you measure the effectiveness and efficiency of your data and processes, as well as the results and outcomes of your risk controls and mitigation strategies. You should also collect feedback from your customers, stakeholders, and employees, and use it to identify gaps, issues, and areas for improvement. You can use tools such as KPIs, audits, and surveys to evaluate and report your performance data.

Integrating ISO 9001 and risk management into your manufacturing operations can help you enhance your data quality, reliability, and security, as well as your process efficiency, productivity, and innovation. As a DBA, you can play a key role in this integration process, by applying the best practices and tools discussed in this article. By doing so, you can add value to your organization and your career, and achieve higher customer satisfaction and loyalty.

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5 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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What are the best practices for integrating ISO 9001 and risk management into your manufacturing operations?

1

2

3

4

5

1 Align your QMS and risk management objectives

2 Conduct a risk assessment and analysis

3 Implement risk controls and mitigation strategies

4 Monitor and review your QMS and risk management performance

5 Here’s what else to consider

Database Administration

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What are the best practices for integrating ISO 9001 and risk management into your manufacturing operations?

1

2

3

4

5

1 Align your QMS and risk management objectives

2 Conduct a risk assessment and analysis

3 Implement risk controls and mitigation strategies

4 Monitor and review your QMS and risk management performance

5 Here’s what else to consider

Database Administration

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