The foodstuff 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 features its own standard (ISO 22000). However, the business must embrace and apply the new concepts embodied inside the ISO 9001:2015 revision in order to meet the challenges of ensuring quality these days, where the application of integrated and sophisticated systems of software and engineering technology applications have grown to be the standard for iso 9001 requirements.
The Federal Food, Drug, and Cosmetic Act was passed by Congress in 1938, after which more “modern” standards, including SQF, GFSI, and Hazard Analysis and Critical Control Points (HACCP) evolved over time to explain best practices. In 2011, the meals Safety Modernization Act (FSMA) was signed into law. The key focus had not been an unexpected: To add risk-based control measures in manufacturing.
Something different to consider is the way technology along with the introduction of automation affected the evolution of best practices. Using human making decisions 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 really a common aspect in production. This demonstrated how automation doesn’t necessarily bring about high 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 from the FDA were aggressively utilized for determining civil and penal crimes due to poor production decision making. Thus, tech-based production and services using good best practices became the norm as companies looked to methods for controlling and improving systems, including those for quality, environment, health and safety, along with software design and make use of.
The most up-to-date revision of ISO 9001 (ISO 9001:2015) follows a similar overall structure as other ISO management systems (generally known as High-Level Structure), rendering it easier for anyone using multiple systems (e.g., ISO 9001 and ISO 22000). It is a major alteration of the most up-to-date 9001 revision.
Another big change is the concentrate on risk-based thinking. Basically, the latest version of your iso 14001 certified environmental management system, which has always been implicit (or implied), explicit (no more optional.) Now there is a need from the standards to create critical and quite often-ignored implicit aspects of application, such as planning and change activities, explicit in implementation. For instance, now explicit within these activities is the use 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 requirement for formal evaluation and activity in assessing the objectives for chosen benchmarks in the business using quality-driven criteria with chosen options 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 effective use of critical thinking skills as a process-based method for quality and safety of goods and services (e.g., quality consulting and auditing).
The new standard now reinforces the chance-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 offered to provide the detail essential for implementing a risk-based program. Such documents include 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 by using a spot inspection by the quality group under the plant manager’s discretion. In comparison, its response document included the use of ISO 9001:2015, which had been a draft international standard or DIS at that time. This manufacturer articulated an aggressive project plan with specific stipulations directly from and then in conformance for the new standard, which ended in an FDA approval. Five months of extensive planning execution over a risk-based system brought successful closure to this particular operation. Factor 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 decision making (Annex B) being a process.
Working with 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 in the second update window. It had been necessary during this meeting to convey the understanding of the critical principles being applied inside the kind of a QMS using ISO 9001:2015. The end result had been a retracted and effectively closed measure of infraction. This 26dexmpky worked with regulators employing a common language to use QSIT along with the law (FSMA, 21CFR 110/111) while providing conformance to a QMS that continues to be ever-improving due to principles and elements to get embraced applying this standard.
As a commentary for closure, it has been refreshing to find out companies who adopt this method with out a historical idea of ISO standards. Moreover, these organizations are very accepting and encouraged by the proactive nature where this r2 certification approach delivers outcomes according to good risk planning in every aspects of their business.