Product Safety and Product Liability Prevention


Three types of product defects to consider during product design evaluations and reduce the risk of product hazards:

1) Design defect: caused by poor designs and/or improper testing. Design defects require corrective action on the entire production. (i.e. Sleepwear flammability failure 16 CFR 1615/16).
2) Manufacturing defect: caused by poor manufacturing processes and procedures. Corrective actions are required on the production lot tracked to the root cause of manufacturing defect. (i.e. lead in surface coatings, 16 CFR 1303).
3) Marketing defect: failure to warn, lack of appropriate warnings of dangers accompanying normal use or misuse of the product. (i.e. misbranded toys/games with small parts, 16 CFR 1500.19).

"There are four purposes of improvement: easier, better, faster, and cheaper. These four goals appear in the order of priority".   Shigeo Shingo

"Product development has 3 stages:   1) System design    2) Parameter design     3) Tolerance design".                    Genichi Taguchi
"We must firmly grasp management.  Just making things isn't enough.  We need to raise the quality."      Deng Xiaoping

"An important feature of a good quality program is that it controls quality at the source".     Armand V. Feigenbaum
"Quality control begins and ends with education".       Kaoru Ishikawa
"Quality is everyone's responsibility".       W. Edwards Deming
"Quality is fitness for us.".     Joseph M. Juran

Design Defect:
Potential root-cause:  

  • International Trade Show Exhibitions featuring white-label product  designs that violate US product safety standards.






Solutions: 

Successful QAP execution requires documents to steer from regulatory ambiguity and drive transparency and control of critical metrics (time, cost, quality):

  1. Milestone Schedule:  set, track and document detail plan to execute requirements (i.e. functions as data recorder for CPSIA).
  2. BOM (bill of materials) Cost Sheet:  verify components and cost to prevent risk of  quality fade.
  3. Product Specification:  document manufacturing requirements and critical control points.

​16 CFR 1115.4   Defect.
Section 15(b)(2) of the CPSA requires every manufacturer (including an importer), distributor, and retailer of a consumer product who obtains information which reasonably supports the conclusion that the product contains a defect which could create a substantial product hazard to inform the Commission of such defect. Thus, whether the information available reasonably suggests a defect is the first determination which a subject firm must make in deciding whether it has obtained information which must be reported to the Commission. In determining whether it has obtained information which reasonably supports the conclusion that its consumer product contains a defect, a subject firm may be guided by the criteria the Commission and staff use in determining whether a defect exists. At a minimum, defect includes the dictionary or commonly accepted meaning of the word. Thus, a defect is a fault, flaw, or irregularity that causes weakness, failure, or inadequacy in form or function. A defect, for example, may be the result of a manufacturing or production error; that is, the consumer product as manufactured is not in the form intended by, or fails to perform in accordance with, its design. In addition, the design of and the materials used in a consumer product may also result in a defect. Thus, a product may contain a defect even if the product is manufactured exactly in accordance with its design and specifications, if the design presents a risk of injury to the public. A design defect may also be present if the risk of injury occurs as a result of the operation or use of the product or the failure of the product to operate as intended. A defect can also occur in a product's contents, construction, finish, packaging, warnings, and/or instructions. With respect to instructions, a consumer product may contain a defect if the instructions for assembly or use could allow the product, otherwise safely designed and manufactured, to present a risk of injury. To assist subject firms in understanding the concept of defect as used in the CPSA, the following examples are offered:
(a) An electric appliance presents a shock hazard because, through a manufacturing error, its casing can be electrically charged by full-line voltage. This product contains a defect as a result of manufacturing or production error.
(b) Shoes labeled and marketed for long-distance running are so designed that they might cause or contribute to the causing of muscle or tendon injury if used for long-distance running. The shoes are defective due to the labeling and marketing.
(c) A kite made of electrically conductive material presents a risk of electrocution if it is long enough to become entangled in power lines and be within reach from the ground. The electrically conductive material contributes both to the beauty of the kite and the hazard it presents. The kite contains a design defect.
(d) A power tool is not accompanied by adequate instructions and safety warnings. Reasonably foreseeable consumer use or misuse, based in part on the lack of adequate instructions and safety warnings, could result in injury. Although there are no reports of injury, the product contains a defect because of the inadequate warnings and instructions.
(e) An exhaust fan for home garages is advertised as activating when carbon monoxide fumes reach a dangerous level but does not exhaust when fumes have reached the dangerous level. Although the cause of the failure to exhaust is not known, the exhaust fan is defective because users rely on the fan to remove the fumes and the fan does not do so.

                    Quality Assurance Planning (QAP) with Project Milestone Schedules

Strategic Level:
Concept Stage: customer needs and expectations convert to product function, features and regulatory standards.
Feasibility Stage: verify technology and resources to the design, produce and market.

Project Turnover from Upstream (art) to Downstream (parts).
Planning Stage: careful, realistic product business planning compliant with product protocols and regulatory standards.
Design Stage:Design Evaluations (DE) with detail design specifications for tool let.

Tactical Level:
Prototype Stage: 3-views, sculpture, tool pattern, works-like model, looks-like model, CAD drawing, photorealistic rendering.
Pilot Stage: Engineering Pilot (EP):  1st Shot, Fit/Function, Line tool let, test to failure (TTF) research, test force diagrams.
                     Final Engineering Pilot (FEP):  Pilot Line tooling, pre-production testing and Quality Assurance Plan.
Validation Stage: Production Pilot (PP):  Pilot Assembly & Pack-out, final pre-production (pre-pro) testing.
Production Stage: Production Start  (PS)  Ramp-up Production, during production (dupro) testing.

Thomas Doyle  MSc.


Manufacturing Defect:
Potential root-causes:  

  • Extreme cost cutting techniques:
    • Excessive use of regrind.
    • Shorten  machine cycle-times.
    • Subcontracting without pre-approval and quality control.




Solutions: 

  • Verify production capacitybased on tool plans and daily production output calculations from labor and machine cycle times standards.  
  • Conduct unannounced quality inspections and reject unapproved subcontracting.
  • Reject use of “Golden Samples”  for product safety testing,
  • Reject  use of “Show-Demo Workshops" for factory audits which can violate CPSIA tracking label compliance  and C-TPAT.

Safe

Marketing Defect:

Potential root causes: 

  • Locally worded instruction sheets without warning statements.
  • Inappropriate age labeling. 
  • Failure to meet US. requirements for  labeling certain toys and games (15 USC 1278).



Solutions: 

  • Verify reasonable and foreseeable use and abuse product safety and liability risks based on age grade.  
  • Improve instructions sheets with appropriate words and warning statements using ANSI Z535 to inform end consumers of potential product hazards and consumer safety risks.
  • Add appropriate  retail packaging warning and age grade labeling based on    15 USC 2052    Definition of children's product.