The meal 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 features its own standard (ISO 22000). However, the business must embrace and apply the latest concepts embodied inside the ISO 9001:2015 revision to meet the difficulties of ensuring quality today, where the usage of integrated and sophisticated systems of software and engineering technology applications have grown to be the standard for iso 9001 quality management system.
The Government Food, Drug, and Cosmetic Act was passed by Congress in 1938, after which more “modern” standards, for example SQF, GFSI, and Hazard Analysis and Critical Control Points (HACCP) evolved with time to explain best practices. In 2011, the meals Safety Modernization Act (FSMA) was signed into law. The key focus had not been a surprise: To include risk-based control measures in manufacturing.
Something diffrent to consider is how technology and the coming of automation affected the evolution of best practices. Using human selection to gauge good or bad product was replaced by Good Engineering Practices, or GEPs. So, spitting out a great deal of bad product faster was a common factor in production. This demonstrated how automation doesn’t necessarily result in top 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 latest quality philosophy. Then federal regulations for quality of product by the FDA were aggressively employed for determining civil and penal crimes due to poor production selection. 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, and also software design and use.
The most up-to-date revision of ISO 9001 (ISO 9001:2015) follows exactly the same overall structure as other ISO management systems (generally known as High-Level Structure), which makes it easier for everyone using multiple systems (e.g., ISO 9001 and ISO 22000). It is a major improvement in the latest 9001 revision.
Another big change is the concentrate on risk-based thinking. Basically, the most recent version from the iso 14001 environmental management, which has long been implicit (or implied), explicit (no longer optional.) Now there is a need within the standards to produce critical and sometimes-ignored implicit elements of application, like planning and change activities, explicit in implementation. For instance, now explicit within 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.
Another change is the key explicit requirement for formal evaluation and activity in assessing the objectives for chosen benchmarks in the market using quality-driven criteria with chosen alternatives for meeting such objectives. S.M.A.R.T. (Specific, Measurable, Actionable, Realistic, Time-bound) driven objectives will need to have regular dashboard review by cross-functional teams within an improvement strategy with the application of critical thinking skills being a process-based approach for quality and safety of products and services (e.g., quality consulting and auditing).
The brand new standard now reinforces the risk-based approach that really must be taken by food and beverage manufacturers. Whether it’s HACCP under Part 110, or risk control measures under FSMA, the methodology is clearly an explicit execution. The upside is perhaps all the support and guidelines offered to provide the detail needed for implementing a risk-based program. Such documents range from the following.
Recently, a manufacturer of your probiotic product was issued a consent decree. At best, its QA program (before the decree) consisted of cryptic QC data with a spot inspection from the quality group underneath the plant manager’s discretion. In contrast, its response document included the use of ISO 9001:2015, which had been a draft international standard or DIS back then. This manufacturer articulated an aggressive project plan with specific stipulations right from and in conformance to the new standard, and also this ended in an FDA approval. Five months of extensive planning execution on the risk-based system brought successful closure to this operation. Key to this example was the guidance of critical points addressed making use of the ISO 9001:2015 standard. Such points included:
Management review with daily involvement in risk and opportunity analysis (6.1);
Planning of changes (6.3) having a risk-based change control process canvassing all change affected conditions (8.5.6) within the QMS (e.g., document change, material change, process change, engineered change, ); and
Event management/CAPA (10.2) using good critical thinking in risk-based making decisions (Annex B) like a process.
Utilizing the FDA district office and independent expertise in legal and consulting efforts for guidance and implementation accelerated the project timeline for this particular company. A FDA follow-up visit occurred during the second update window. It had been necessary in this meeting to convey the knowledge of the critical principles being applied in the type of a QMS using ISO 9001:2015. The result was a retracted and effectively closed amount of infraction. This 26dexmpky dealt with regulators employing a common language to use QSIT as well as the law (FSMA, 21CFR 110/111) while providing conformance to some QMS that remains ever-improving due to the principles and elements to get embraced using this standard.
As being a commentary for closure, it has been refreshing to view companies who adopt this process without having a historical understanding of ISO standards. Moreover, these businesses are incredibly accepting and encouraged with the proactive nature in which this r2 certification requirements approach delivers outcomes based on good risk planning in all areas of their business.