How ISO 9001:2015 Will Impact Food Manufacturers

Food Manufacturers Take Note
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 is all the support and guidelines available to provide the detail necessary for implementing a risk-based program. Such documents include the following.

• Management of Risk – BSI document that relates Management of Change
• ISO 31000/ISO 31010 – Operational Risk Standard and companion risk toolbox guideline
• ISO 14971/ISO/TR 14969:2005 – Product risk standard and application improvement guideline for med device products (crossover considerations for product attribute risks)
• ICH-Q9 – Harmonization guideline for pharmaceutical manufacturing (IMDRF.org)
• IMDRF SG3/N15R6 – International Risk Management guideline
• IMDRF GHTF/AHWG-GRM/N1R13:2011 – Guideline regulatory model for regulated products

To Apply or Not to Apply: A Worst-Case Scenario
Recently, a manufacturer of a probiotic product was issued a consent decree. At best, its QA program (before the decree) consisted of cryptic QC data with a spot inspection by the quality group under the plant manager’s discretion. By comparison, its response document included the application 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 to the new standard, and this resulted in an FDA approval. Five months of extensive planning execution on a risk-based system brought successful closure to this operation. Key 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 decision making (Annex B) as 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 company. A FDA follow-up visit occurred during the second update window. It was necessary during this meeting to convey the understanding of the critical principles being applied in the model of a QMS using ISO 9001:2015. The outcome was a retracted and effectively closed level of infraction. This company worked with regulators using a common language to apply QSIT and the law (FSMA, 21CFR 110/111) while providing conformance to a QMS that remains ever-improving due to the principles and elements to be embraced using this standard.

As a commentary for closure, it has been refreshing to see companies who adopt this approach without a historical understanding of ISO standards. Moreover, these companies are very accepting and encouraged by the proactive nature in which this QMS approach delivers outcomes based on good risk planning in all aspects of their business.

Murray is the director of quality and compliance services at MasterControl. Reach him at [email protected].