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 features its own standard (ISO 22000). However, the business must embrace and apply the new concepts embodied in the ISO 9001:2015 revision to meet the challenges of ensuring quality today, where using integrated and sophisticated systems of software and engineering technology applications have grown to be the norm for iso 9001 consultant.
The Government Food, Drug, and Cosmetic Act was passed by Congress in 1938, then more “modern” standards, like SQF, GFSI, and Hazard Analysis and Critical Control Points (HACCP) evolved with time to clarify best practices. In The Year 2011, the meal Safety Modernization Act (FSMA) was signed into law. The key focus had not been a surprise: To incorporate risk-based control measures in manufacturing.
Something else to take into consideration is the way technology and the advent 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 a lot of bad product faster was a common consider 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 from the FDA were aggressively used for determining civil and penal crimes resulting from poor production making decisions. Thus, tech-based production and services using good best practices took over as the norm as companies looked to methods of 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 (referred to as High-Level Structure), that makes it easier for everyone using multiple systems (e.g., ISO 9001 and ISO 22000). This is a major alteration of the most up-to-date 9001 revision.
Another big change is the center on risk-based thinking. Basically, the newest version of your iso 14001 environmental management, which has always been implicit (or implied), explicit (not any longer optional.) Now there is a need within the standards to create critical and often-ignored implicit elements of application, including planning and alter activities, explicit in implementation. For instance, now explicit in these activities is the effective use of risk-based selection, control measures for change and risk application, along with the specific utilization of data-driven measurement and analysis.
Another change is the key explicit requirement for formal evaluation and activity in assessing the objectives for chosen benchmarks in the market 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 use of critical thinking skills like a process-based approach for quality and safety of services and products (e.g., quality consulting and auditing).
The latest 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 available to supply the detail necessary for implementing a danger-based program. Such documents add the following.
Recently, a manufacturer of any probiotic product was issued a consent decree. At best, its QA program (before the decree) was comprised of cryptic QC data with a spot inspection with the quality group within the plant manager’s discretion. By comparison, its response document included the effective use of ISO 9001:2015, that was a draft international standard or DIS at the time. This manufacturer articulated an aggressive project plan with specific stipulations straight from and also in conformance to the new standard, and also this ended in an FDA approval. Five months of extensive planning execution on a risk-based system brought successful closure to the 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) by using a risk-based change control process canvassing all change affected conditions (8.5.6) from 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.
Dealing 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 throughout the second update window. It absolutely was necessary throughout this meeting to convey the knowledge of the critical principles being applied within the kind of a QMS using ISO 9001:2015. The end result was really a retracted and effectively closed measure of infraction. This 26dexmpky worked with regulators employing a common language to apply QSIT and the law (FSMA, 21CFR 110/111) while providing conformance to a QMS that remains ever-improving as a result of principles and elements being embraced by using this standard.
Being a commentary for closure, it really has been refreshing to view companies who adopt this method without a historical understanding of ISO standards. Moreover, these companies are really accepting and encouraged with the proactive nature by which this r2 certification approach delivers outcomes according to good risk planning in all areas of their business.