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Quality Management System Must-Haves: 3 Ways to Eliminate Risk

For manufacturers in regulated industries, Quality Management Systems (QMS) are a necessity. To ensure consistent quality products, and demonstrate that to customers, most manufacturers follow ISO 9001, the flagship quality management systems standard. However, even manufacturers that are not ISO certified must comply with quality management standards to meet industry-specific regulations.

risk_assessment.jpgLast fall, the International Organization for Standardization (ISO) published a new version of the international standard for Quality Management Systems, ISO 9001:2015. There are two key themes impacting most manufacturers. First, the new version is designed to integrate with industry-specific regulations, making it easier for manufacturers to align multiple management system compliance and leverage processes, procedures, and reporting among systems. The second theme is an increased focus on performance with more importance placed on risk-based thinking.

Based on Novatek’s experience providing Process Protection to manufacturers, here are the most common areas of risk we notice:

3 Overlooked Areas Creating Risk and What You Can Do

1. Risk Assessment

Many manufacturers overlook this valuable activity because, consistent with ISO’s approach to allowing companies to identify their own documentation needs to manage their processes, there is not currently a requirement for risk assessment. However, assessing the risks in your process and applying risk-based thinking can improve speed and efficiency when problems do occur, which saves companies valuable money and reputational impact.

To ensure you’ve adequately anticipated problems, taken steps to prevent them, and have processes in place to handle these problems if they do occur, conduct a risk assessment that includes the following:

What potential problems might occur?
What are the cost implications of each problem?
How can the company avoid each problem?
How can the company mitigate the risk of each problem occurring?
What level of risk is the company willing to accept for each problem?
What steps must the company take to ensure appropriate actions if these problems occur?
What process and procedures must be created or updated to reflect the company’s risk avoidance and mitigation decisions?
How will the company continue to recognize potential threats?
How can the company continually assess risk through our internal auditing procedures?

2. Common Sense
Quality management is about more than meeting a list of requirements. When manufacturers focus on compliance or certification as a means to an end to becoming a valid industry supplier, common sense can get lost along the way to achieve the true purpose of ensuring quality, safety and efficiency. Risk increases when a company loses sight of this purpose or a QMS effort grows so big that processes and procedures go unchecked, resulting in contractor, redundant and used documents.

Here are some common sense reminders for attaining QMS documentation requirements:

  • To ensure your QMS is comprehensive and reflective of your process, document what you do. And don’t forget to do what you document!
  • To ensure procedures are useful at achieving quality, safety and efficiency include a clear purpose, definition, scope, ownership and approval.
  • To ensure processes and procedures are always accurate, create a document control systems that also protect from unauthorized revision.
  • To ensure processes and procedures are followed consistently, create training so employees know where to find procedures, how to follow them, and how to complete reports.
  • To ensure processes and procedures are always accessible (especially during an audit), create practices that protect documents from destruction, corruption and unintended use.
3. Isolated Development

Some companies rely exclusively on their quality management team or leadership executives to define the company’s quality system. However, this increases risk if the system doesn’t accurately follow the company’s processes; something these individuals may be far removed from.

While, the adoption of a QMS is a strategic decision and needs buy-in from company leadership, it is influenced by varying needs, types of products and services provided, existing processes, and the size of the company. To ensure your QMS is not developed in isolation, involve the following stakeholders:

Management
Involve management in establishing measurable objectives so they have buy-in and can demonstrate to their teams that they are fully committed to developing and improving the QMS.

Customer Usability Experts
Involve the customer usability experts to ensure the end product conforms to customer needs and expectations.

Operators
Involve operators to identify core processes and sub-processes and assist in the development of the procedures. Utilize these stakeholders as “process owners” to provide local control of these processes.

All Employees
After deployment, involve all company employees in the measurement by showing their contribution to the company’s goals through scorecards and dashboards. Communicate the outcomes of QMS reviews to all employees so they are aware of progress toward expected outcomes or improvement activities.

For guidance on developing QMS procedures…

Download our free worksheet:
Standard Operating Procedures Worksheet

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Topics: Quality System documentation, Process documentation, SOPs

 EU MDR