The meal and beverage industry possesses its own toolkit for quality (e.g., Safe Quality Foods Program, or SQF, and Global Food Safety Initiative, or GFSI). It even possesses its own standard (ISO 22000). However, the industry must embrace and apply the newest concepts embodied inside the ISO 9001:2015 revision to satisfy the challenges of ensuring quality in the 21st century, where the usage of integrated and sophisticated systems of software and engineering technology applications have grown to be the standard for iso 9001 consultants.
The Government Food, Drug, and Cosmetic Act was passed by Congress in 1938, then more “modern” standards, such as SQF, GFSI, and Hazard Analysis and Critical Control Points (HACCP) evolved over time to explain best practices. In 2011, the meal Safety Modernization Act (FSMA) was signed into law. The primary focus had not been an unexpected: To incorporate risk-based control measures in manufacturing.
Something else to think about is how technology as well as the coming 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 plenty of bad product faster was actually a common aspect in production. This demonstrated how automation doesn’t necessarily bring about 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 new quality philosophy. Then federal regulations for quality of product through the FDA were aggressively used for determining civil and penal crimes caused by poor production selection. Thus, tech-based production and services using good best practices had become the norm as companies looked to ways for controlling and improving systems, including those for quality, environment, safety and health, as well as software design and utilize.
The most up-to-date revision of ISO 9001 (ISO 9001:2015) follows exactly the same overall structure as other ISO management systems (known as High-Level Structure), rendering it easier for any individual using multiple systems (e.g., ISO 9001 and ISO 22000). This can be a major improvement in the most up-to-date 9001 revision.
Another big change is definitely the give attention to risk-based thinking. Basically, the latest version in the iso 14001 environmental management, which has always been implicit (or implied), explicit (not any longer optional.) Now you have the need in the standards to create critical and frequently-ignored implicit parts of application, like planning and alter activities, explicit in implementation. As an example, now explicit over these activities is the application of risk-based making decisions, control measures for change and risk application, and also the specific utilization of data-driven measurement and analysis.
Still another change is key explicit need 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 must have regular dashboard review by cross-functional teams in a improvement strategy with the effective use of critical thinking skills as a process-based approach for quality and safety of goods and services (e.g., quality consulting and auditing).
The latest standard now reinforces the danger-based approach that 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 all the support and guidelines available to provide the detail necessary for implementing a danger-based program. Such documents are the following.
Recently, a manufacturer of the probiotic product was issued a consent decree. At best, its QA program (before the decree) was comprised of cryptic QC data by using a spot inspection by the quality group underneath the plant manager’s discretion. In contrast, its response document included the application of ISO 9001:2015, which was a draft international standard or DIS during the time. This manufacturer articulated an aggressive project plan with specific stipulations from and also in conformance for the new standard, and also this ended in an FDA approval. Five months of extensive planning execution with a risk-based system brought successful closure for this operation. Answer to this example was the guidance of critical points addressed while using ISO 9001:2015 standard. Such points included:
Management review with daily involvement in risk and opportunity analysis (6.1);
Planning of changes (6.3) by using 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 selection (Annex B) as being a process.
Working together with the FDA district office and independent knowledge of 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 was actually necessary in this meeting to convey the idea of the critical principles being applied within the model of a QMS using ISO 9001:2015. The outcome was actually a retracted and effectively closed level of infraction. This 26dexmpky worked with regulators by using a common language to make use of QSIT as well as the law (FSMA, 21CFR 110/111) while providing conformance to a QMS that remains ever-improving due to the principles and elements to be embraced using this standard.
As being a commentary for closure, it really has been refreshing to discover companies who adopt this method with out a historical comprehension of ISO standards. Moreover, these companies are extremely accepting and encouraged with the proactive nature through which this r2 certification requirements approach delivers outcomes according to good risk planning in most facets of their business.