The meal 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 has its own standard (ISO 22000). However, the marketplace must embrace and apply the latest concepts embodied in the ISO 9001:2015 revision to satisfy the challenges of ensuring quality these days, where using integrated and sophisticated systems of software and engineering technology applications have grown to be the norm for iso 9001 consultants.
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 over time to explain best practices. In The Year 2011, the meal Safety Modernization Act (FSMA) was signed into law. The principal focus was not a surprise: To incorporate risk-based control measures in manufacturing.
Something different to take into account is just how technology as well as the coming of automation affected the evolution of best practices. Using human making decisions to judge 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 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 new quality philosophy. Then federal regulations for quality of product with the FDA were aggressively employed for determining civil and penal crimes resulting from poor production making decisions. Thus, tech-based production and services using good best practices had become the norm as companies looked to methods for controlling and improving systems, including those for quality, environment, health and safety, and also software design and make use of.
The latest revision of ISO 9001 (ISO 9001:2015) follows the same overall structure as other ISO management systems (known as High-Level Structure), making it easier for any individual using multiple systems (e.g., ISO 9001 and ISO 22000). This really is a major improvement in the most up-to-date 9001 revision.
Another big change is the focus on risk-based thinking. Basically, the newest version from the ems iso 14001, which has long been implicit (or implied), explicit (will no longer optional.) Now there is the need from the standards to create critical and frequently-ignored implicit components of application, like planning and alter activities, explicit in implementation. As an example, now explicit during these activities is the application of risk-based selection, control measures for change and risk application, and the specific utilization of data-driven measurement and analysis.
Still another change is vital explicit requirement of 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 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 (e.g., quality consulting and auditing).
The new standard now reinforces the risk-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 will be all the support and guidelines offered to give you the detail essential for implementing a danger-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) was made up of cryptic QC data with a spot inspection with the quality group within the plant manager’s discretion. In comparison, its response document included the application of ISO 9001:2015, which was a draft international standard or DIS at that time. This manufacturer articulated an aggressive project plan with specific stipulations right from and in conformance to the new standard, and this led to an FDA approval. Five months of extensive planning execution with a risk-based system brought successful closure for this operation. Step 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) with a risk-based change control process canvassing all change affected conditions (8.5.6) in 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) as a process.
Dealing 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 during the second update window. It had been necessary throughout this meeting to convey the understanding of the critical principles being applied from the type of a QMS using ISO 9001:2015. The end result was actually a retracted and effectively closed amount of infraction. This 26dexmpky worked with regulators utilizing a common language to apply QSIT and the law (FSMA, 21CFR 110/111) while providing conformance to some QMS that continues to be ever-improving due to principles and elements to become embraced employing this standard.
Like a commentary for closure, this has been refreshing to discover companies who adopt this strategy with out a historical idea of ISO standards. Moreover, these firms are really accepting and encouraged through the proactive nature through which this r2 certification requirements approach delivers outcomes according to good risk planning in most areas of their business.