Step 9.2

Troubleshoot and correct problems.

Primary Findings

Secondary Findings

Primary findings

Barriers

Devices used in clinical care are particularly hard to improve incrementally based on field results because processes must be standardized, as must training. Variations in training and implementation skew user feedback. 
Postmarket questionnaire results
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Carriers

Complaint and issue feedback databases store and quantify issues with devices and processes in a more standard method than human resource led initiatives, which are less empirical and more likely to give employees qualms about sharing.
Postmarket questionnaire results
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Individually addressing consequential problems and unintended outcomes results in incremental innovation. These gradual developments can lead to radical breakthroughs. 
Research conclusions from conceptual framework 
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Failure mode effect analysis (FMEA) techniques help the design team to study the causes and effects of product failures. FMEA specifies the various conditions the product will endure, and tests, how it reacts under those conditions, allowing designers to plan a product that will withstand a broader range.
Experiential. Authors' knowledge.
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Methods

Continually observe and correct problems or errors made by team members to improve the quality of decision making and implementation.
Literature review
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Failure Knowledge Network (FKN) — captures and inter-relates mechanical product quality knowledge from five areas: (i) the connection between failures and product functions, (ii) the relationship between failures and product components, (iii) the correlation between failures and organizations, (iv) the association between failures and product processes, and (v) the conjunction among different failures. FKN information is represented in a four-dimensional matrix that includes components, functions, processes and organization. Each element in the matrix is a failure scenario and represents the related failures within the corresponding dimensions. Conventional factors of failures are embodied in the FKN representation. They include event, detection, effect, severity, solution weight, cause, monitor, reappearance, operation, efficiency and precaution. The indexes of each factor are provided by subject matter experts and are set in accordance with the correlation between corresponding characteristics and failures
Failure knowledge based decision-making in product quality.
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Product quality-related decision-making using the Failure Knowledge Network (FKN) — The first step of the decision-making process is the identification of related failures and characteristics. The second step is determination of the important characteristics of the clusters. Next, there is a comparison between the characteristics of each target. Finally, the interdependent priorities of the characteristics are determined by analyzing dependencies among the targets and characteristics.
Failure knowledge based decision-making in product quality.
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Secondary findings

Barriers

One drawback to using Failure Modes and Effects Analysis (FMEA) is that it has deficiencies in the expression of the relationship between different failure components. As a result it can not be used as a technique for knowledge formulation. One way to represent and share failure information is to construct a knowledge network of failure scenarios.
Source: Dai (2009). In: Dai,W., Maropoulos, P.G. &Tang, X.Q. (2010)

One of the reasons that product quality failures reoccur is that the knowledge of past failures is not well represented or readily-available to respective parties. One way to represent and share past failures is to construct a knowledge network of failure scenarios.
Source: Hatamura (2003). In: Dai,W., Maropoulos, P.G. &Tang, X.Q. (2010)

Tips

Pharmaceutical companies are heavily scrutinized and collect extensive testing data which is useful for incremental development. Producers in other less regulated disciplines (devices, clinical care procedures) could benefit from such a well-documented R&D process.  
Postmarket questionnaire results
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Use the Internet to assist with customer and product support. Train salespeople and provide them answers to product questions online.
Source: The Baan Company: Case Study (2002), FileNew Corp: Case Study (2002), Tompkins Group: Case Study (2002). In: Ozer, M. (2003)