Sep 20, 2017

How Quality System Harmonization Supports Growth


Do any of These Quality System Challenges Sound Familiar?

“Me too” nonconformances or 483 observations occurring in different areas of the business.

“We do it this way” responses that differ by area when you ask employees how they execute quality system requirements.

“I didn’t know that” responses when asked about an organizational quality goal.

“How will we roll this out across the company?” when there is a need to transition to new requirements such as MDSAP, the new European Union medical device regulations, and ISO 13485:2016.

You Have Quality System Variations Due to Growth

A successful business is a growing business. The growth may be organic or due to acquisitions, but the result is the same: quality system variations. While individual facilities, plants, or divisions may comply with standards and regulations (e.g., ISO 13485 and FDA’s QSR), the company cannot determine if these separate quality systems meet the needs of the overall organization.

This variation arises because quality system regulations and standards tell organizations WHAT to do, while allowing great flexibility in HOW to meet requirements. As a result, when an organization expands, there are differences in how its various areas comply with quality management system (QMS) requirements.

Common issues include:

  • Broken quality system linkages as the organization changes.
  • Incomplete integration of acquisitions into the organization’s overall quality model.
  • Lack of definition – and communication – of quality expectations and measures by the organization’s top management.

These issues make it difficult for senior management to assess the application of QMS requirements throughout the company. The lack of clarity reduces confidence in the “state of control” of each specific quality system and prevents the establishment of measurable organization-wide quality goals. Most important, this variation impacts internal controls and attracts regulator attention.

The Solution: Quality System Harmonization

A harmonized QMS transforms variation into a cohesive whole. The effect is like a conductor raising the baton for an orchestra. Harmonization establishes consistent processes, procedures, and metrics throughout an organization’s operations and locations.

The standardized framework allows top management to measure quality and compliance across the company. This ability provides a better sense of control and supports the data-based business decisions that drive performance excellence.

It is important to note, however, that a harmonized quality system does not require all locations to follow the same processes. Site-level processes may remain unique, just as an orchestra consists of different instruments. The value of the harmonized system is the unified base it provides that enables the organization to share best practices and improve.

When Should Organizations Consider Quality System Harmonization?

Common triggers for considering a harmonization initiative include:

  • Organizational growth
  • Exploring the acquisition of other companies
  • Multiple nonconformities/findings along a specific theme occurring throughout the organization’s operations and locations
  • The company needs to boost operational performance
  • Regulator scrutiny

As an organization grows, regulators increase their expectations. They know that growth, especially rapid growth, can generate quality problems. The ability to demonstrate consistent control throughout the organization with a harmonized quality system provides objective reassurance to regulators.

Quality System Harmonization: Where to Start

Oriel STAT A MATRIX recommends a six-step approach to quality system harmonization:

  • Step 1: Identify the variation in the current state using tools such as process maps, responsibility matrices, and gap assessments.
  • Step 2: Develop and align the harmonization program goals.
  • Step 3: Establish organizational quality metrics.
  • Step 4: Design a future-state organizational QMS that minimizes variation, leverages best practices, and allows for product-specific flexibility.
  • Step 5: Develop and deploy the plan.
  • Step 6: Measure and improve.

The Outlook for the Quality System: Excellent

Harmonization can transform a variety of quality system practices into a cohesive, measurable whole. The quality system is then able to support the company’s continued growth and ability to efficiently transition to new requirements such as MDSAP, the new EU regulations, and ISO 13485:2016.

Find out how Oriel STAT A MATRIX helps organizations of all sizes complete one or more of the six steps for creating a harmonized quality system. Contact us.

About the author

Chad Hedlund-quality system harmonization-OrielSTATAMATRIXChad Hedlund provides the overall strategic leadership for Oriel STAT A MATRIX’s Life Sciences Consulting and Education services. His focus is on guiding our customers to a successful market entry of their product (e.g., medical device, IVD, or combination product) while also building and optimizing our customers’ quality and regulatory compliance functions in a manner that balances shareholder, customer, global regulatory, and employee needs. Chad’s experience in life sciences quality management systems and regulatory compliance spans nearly two decades and includes quality, regulatory compliance, technical, and leadership roles at companies such as Medtronic, Boston Scientific, and Guidant.

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