The meal 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 possesses its own standard (ISO 22000). However, the industry must embrace and apply the latest concepts embodied in the ISO 9001:2015 revision to meet the challenges of ensuring quality in the 21st century, where using integrated and sophisticated systems of software and engineering technology applications are getting to be the standard for iso 9001 internal audit.
The Government Food, Drug, and Cosmetic Act was passed by Congress in 1938, and then more “modern” standards, such as SQF, GFSI, and Hazard Analysis and Critical Control Points (HACCP) evolved as time passes to explain best practices. In 2011, the Food Safety Modernization Act (FSMA) was signed into law. The main focus had not been a surprise: To add risk-based control measures in manufacturing.
Another thing to consider is how technology as well as the development 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 great deal 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 useful 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 use.
The newest revision of ISO 9001 (ISO 9001:2015) follows the same overall structure as other ISO management systems (called High-Level Structure), rendering it easier for anyone using multiple systems (e.g., ISO 9001 and ISO 22000). This is a major alteration of the most recent 9001 revision.
Another big change will be the focus on risk-based thinking. Basically, the newest version of your ems iso 14001, which has long been implicit (or implied), explicit (no longer optional.) Now there is the need inside the standards to make critical and often-ignored implicit parts of application, like planning and alter activities, explicit in implementation. As one example, now explicit over these activities is the effective use of risk-based decision making, control measures for change and risk application, and also the specific utilization of data-driven measurement and analysis.
A third change is the key 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 use of critical thinking skills as a process-based approach for quality and safety of services and products (e.g., quality consulting and auditing).
The brand new standard now reinforces the chance-based approach that really 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 necessary for implementing a danger-based program. Such documents add the following.
Recently, a manufacturer of the probiotic product was issued a consent decree. At best, its QA program (just before the decree) contained cryptic QC data by using a spot inspection with the quality group beneath the plant manager’s discretion. In contrast, its response document included the effective use of ISO 9001:2015, that has been a draft international standard or DIS during the time. This manufacturer articulated an aggressive project plan with specific stipulations straight from and also in conformance towards the new standard, which resulted in an FDA approval. Five months of extensive planning execution on a risk-based system brought successful closure to this particular operation. Key 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) 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 decision making (Annex B) like 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 just for this company. A FDA follow-up visit occurred through the second update window. It was actually necessary during this meeting to convey the knowledge of the critical principles being applied from the type of a QMS using ISO 9001:2015. The outcome was actually a retracted and effectively closed level of infraction. This 26dexmpky worked with regulators utilizing a common language to make use of QSIT along with the law (FSMA, 21CFR 110/111) while providing conformance to a QMS that remains ever-improving because of the principles and elements being embraced applying this standard.
As being a commentary for closure, it has been refreshing to view companies who adopt this approach without a historical understanding of ISO standards. Moreover, these firms are extremely accepting and encouraged from the proactive nature where this r2 certification requirements approach delivers outcomes based on good risk planning in all aspects of their business.