Managing Compliance Risk

Some of the attributes to consider when writing a worst-case rationale, whether it be for similar devices that use the same packaging system or a worst-case packaging configuration, are weight, geometry, distribution environment and device fragility. Have you considered these attributes in your worst case rationale?

Sampling plans are required per ISO 11607. The specific sampling plan is dependent on many factors including distribution test method assurance level, risk level from failure mode and effective analyses, and confidence and reliability requirements. What are your organization’s tolerance levels? What sample size plans have you used and justified for previous products?

Ensure proper justification for temperature for accelerated aging and temperature and humidity requirements for real time aging/stability. What is your organization’s definition of “ambient”? Can you obtain real time aging data from your supplier?

Minimum specification requirements are dependent on many factors and are continually challenged within the industry. Does your company follow the ‘standard’ 1 lb. minimum? What seal strength does the weight of your product require from your packaging?

ISO 11607 requires labels to be adhered and legible as part of acceptance criteria during design verification. Legibility can be subjective, so ensuring you follow a standardized test method or use an in-house test method that has been validated is crucial. Have you considered your label legibility after distribution testing?