The meals 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 industry must embrace and apply the new concepts embodied within the ISO 9001:2015 revision to satisfy the challenges of ensuring quality nowadays, where using integrated and sophisticated systems of software and engineering technology applications are getting to be the norm for iso 9001 consultants.
The Federal Food, Drug, and Cosmetic Act was passed by Congress in 1938, after which more “modern” standards, like SQF, GFSI, and Hazard Analysis and Critical Control Points (HACCP) evolved as time passes to clarify best practices. In 2011, the meals Safety Modernization Act (FSMA) was signed into law. The main focus had not been an unexpected: To add risk-based control measures in manufacturing.
Something else to take into account is when technology as well as the introduction 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 lot of bad product faster was really a common factor in production. This demonstrated how automation doesn’t necessarily result in 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 new quality philosophy. Then federal regulations for quality of product through the FDA were aggressively used for determining civil and penal crimes as a result of poor production decision making. Thus, tech-based production and services using good best practices took over as 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 make use of.
The latest revision of ISO 9001 (ISO 9001:2015) follows a similar overall structure as other ISO management systems (called 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 most up-to-date 9001 revision.
Another big change will be the give attention to risk-based thinking. Basically, the newest version in the iso 14001 environmental management, which has always been implicit (or implied), explicit (no longer optional.) Now there is the need from the standards to help make critical and sometimes-ignored implicit components of application, such as planning and alter activities, explicit in implementation. As an example, now explicit over these activities is the effective use 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 need 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 need to have regular dashboard review by cross-functional teams in a improvement strategy with the effective use of critical thinking skills like a process-based means for quality and safety of goods and services (e.g., quality consulting and auditing).
The latest 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 perhaps all the support and guidelines accessible to supply the detail required for implementing a risk-based program. Such documents are the following.
Recently, a manufacturer of a probiotic product was issued a consent decree. At best, its QA program (before the decree) was comprised of cryptic QC data having a spot inspection through the quality group beneath the plant manager’s discretion. By comparison, its response document included the use of ISO 9001:2015, which was a draft international standard or DIS at the time. This manufacturer articulated an aggressive project plan with specific stipulations directly 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 for this operation. Key to this example was the guidance of critical points addressed utilizing 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) 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 being a process.
Working together with the FDA district office and independent expertise in 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 within this meeting to convey the comprehension of the critical principles being applied inside the model of a QMS using ISO 9001:2015. The result was really a retracted and effectively closed degree of infraction. This 26dexmpky worked with regulators utilizing a common language to use QSIT and also the law (FSMA, 21CFR 110/111) while providing conformance to your QMS that stays ever-improving due to principles and elements being embraced by using this standard.
Like a commentary for closure, it has been refreshing to discover companies who adopt this strategy without having a historical understanding of ISO standards. Moreover, these companies are extremely accepting and encouraged with the proactive nature through which this r2 rios certified electronics recycle approach delivers outcomes according to good risk planning in all areas of their business.