How ISO 9001:2015 Will Impact Food Manufacturers

The food and beverage industry has its own toolkit for quality (e.g., Safe Quality Foods Program, or SQF, and Global Food Safety Initiative, or GFSI). It even has its own standard (ISO 22000). However, the industry must embrace and apply the new concepts embodied in the ISO 9001:2015 revision to meet the challenges of ensuring quality in the 21st century, where the use of integrated and sophisticated systems of software and engineering technology applications have become the norm for achieving quality and consumer safety.

The Advent of Best Practices
The Federal Food, Drug, and Cosmetic Act was passed by Congress in 1938, and then more “modern” standards, such as SQF, GFSI, and Hazard Analysis and Critical Control Points (HACCP) evolved over time to clarify best practices. In 2011, the Food Safety Modernization Act (FSMA) was signed into law. The primary focus was not a surprise: To incorporate risk-based control measures in manufacturing.

Something else to consider is how technology and the advent of automation affected the evolution of best practices. Using human decision making to evaluate good or bad product was replaced by Good Engineering Practices, or GEPs. So, spitting out lots of bad product faster was a common factor in production. This demonstrated how automation doesn’t necessarily lead to good quality. Quality gurus were making their mark on controlling bad production with decision-based QC and QA. The likes of Deming, Juran, Feigenbaum, and Crosby were all advocating the new quality philosophy. Then federal regulations for quality of product by the FDA were aggressively used for determining civil and penal crimes resulting from poor production decision making. Thus, tech-based production and services using good best practices became the norm as companies looked to ways for controlling and improving systems, including those for quality, environment, health and safety, as well as software design and use.

Controls and the ISO Standards
Quality Management System (QMS) ISO standards have been created for all major sectors of manufacturing to answer an important need: A systematic application to improve and control the quality and the safety of consumer products. There are key components and changes to these standards common to manufacturers in most industries. These components include:

  • Design control,
  • Documentation and record control,
  • Supplier(s) control,
  • Measurement control and analysis,
  • Data use for validation/verification,
  • Elimination of Corrective and Preventive Action (CAPA)—now referred to as Risk Opportunity Analysis,
  • Non-conformance and corrective action,
  • Improvement application,
  • Management planning and oversight,
  • Change control (risk-based),
  • Contamination controls, and
  • Infrastructure and work environment controls.

ISO Standards Evolution
The latest revision of ISO 9001 (ISO 9001:2015) follows the same overall structure as other ISO management systems (known as High-Level Structure), which makes it easier for anyone using multiple systems (e.g., ISO 9001 and ISO 22000). This is a major change in the latest 9001 revision.

Another big change is the focus on risk-based thinking. Basically, the latest version of the standard makes risk management, which has always been implicit (or implied), explicit (no longer optional.) Now there is the need in the standards to make critical and often-ignored implicit components of application, such as planning and change activities, explicit in implementation. As an example, now explicit in these activities is the application of risk-based decision making, control measures for change and risk application, and the specific use of data-driven measurement and analysis.

A third change is the key explicit requirement for formal evaluation and activity in assessing the objectives for chosen benchmarks in the business using quality-driven criteria with chosen alternatives for meeting such objectives. S.M.A.R.T. (Specific, Measurable, Actionable, Realistic, Time-bound) driven objectives must have regular dashboard review by cross-functional teams in an improvement strategy with the application of critical thinking skills as a process-based approach for quality and safety of products and services (e.g., quality consulting and auditing).

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