The food and beverage industry features 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 market must embrace and apply the brand new concepts embodied in 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 become the standard for iso 9001 requirements.
The Government Food, Drug, and Cosmetic Act was passed by Congress in 1938, and after that more “modern” standards, such as SQF, GFSI, and Hazard Analysis and Critical Control Points (HACCP) evolved over time to explain best practices. This Year, the foodstuff Safety Modernization Act (FSMA) was signed into law. The primary focus had not been an unexpected: To feature risk-based control measures in manufacturing.
Another thing to take into consideration is just how technology and the introduction of automation affected the evolution of best practices. Using human making decisions 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 factor in production. This demonstrated how automation doesn’t necessarily bring about 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 brand 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 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, health and safety, in addition to software design and make use of.
The most recent revision of ISO 9001 (ISO 9001:2015) follows exactly 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 improvement in the newest 9001 revision.
Another big change may be the focus on risk-based thinking. Basically, the most recent version from the iso 14001 environmental management, which has always been implicit (or implied), explicit (not any longer optional.) Now there is the need in the standards to make critical and sometimes-ignored implicit elements of application, such as planning and alter activities, explicit in implementation. For example, now explicit during these activities is the application of risk-based selection, control measures for change and risk application, along with the specific utilization of data-driven measurement and analysis.
Still another change is the key explicit need for formal evaluation and activity in assessing the objectives for chosen benchmarks in the industry using quality-driven criteria with chosen options for meeting such objectives. S.M.A.R.T. (Specific, Measurable, Actionable, Realistic, Time-bound) driven objectives should have regular dashboard review by cross-functional teams within an improvement strategy with the effective use of critical thinking skills being a process-based method for quality and safety of services and products (e.g., quality consulting and auditing).
The new standard now reinforces the danger-based approach that must definitely 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 actually all the support and guidelines open to give you the detail necessary for implementing a risk-based program. Such documents add the following.
Recently, a manufacturer of the probiotic product was issued a consent decree. At best, its QA program (before the decree) consisted of cryptic QC data having a spot inspection by the quality group beneath the plant manager’s discretion. In contrast, its response document included the application of ISO 9001:2015, that was a draft international standard or DIS at that time. This manufacturer articulated an aggressive project plan with specific stipulations from and in conformance on the new standard, and that led to an FDA approval. Five months of extensive planning execution on the risk-based system brought successful closure to this operation. Factor to this example was the guidance of critical points addressed using 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) 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 company. A FDA follow-up visit occurred in the second update window. It had been necessary throughout this meeting to convey the understanding of the critical principles being applied in the style of a QMS using ISO 9001:2015. The outcome was a retracted and effectively closed level of infraction. This 26dexmpky worked with regulators employing a common language to make use of QSIT as well as the law (FSMA, 21CFR 110/111) while providing conformance into a QMS that stays ever-improving because of the principles and elements being embraced by using this standard.
As a commentary for closure, it really has been refreshing to discover companies who adopt this method without a historical idea of ISO standards. Moreover, these companies are extremely accepting and encouraged from the proactive nature by which this r2 certification approach delivers outcomes according to good risk planning in all facets of their business.