Correlating Product Lifecycle and Manufacturing Site Characteristics with Product Deviations - MIT survey results address product and site characteristics that statistically correlate with quality per


Correlating Product Lifecycle and Manufacturing Site Characteristics with Product Deviations
MIT survey results address product and site characteristics that statistically correlate with quality performance.

BioPharm International
Volume 25, Issue 10, pp. 50-53

Distribution of technical personnel within the manufacturing sites

Figure 1: Fraction of personnel associated with each of the technical areas at different sites.
The distribution of technical personnel within a manufacturing site provides some representation of the priorities and/or focus of the site. The sites reported the number of personnel in each of the following technical areas: Quality control (QC)—average 12.6%; Quality assurance (QA)—average 17.4%; Engineering support and services—average 8.8%; Technical services—average 16.3%; and Manufacturing:—average 44.9%.

Figure 2: Fraction of technical personnel in a manufacturing position across sites surveyed.
A histogram with the fraction of personnel in each of the first four areas is presented in Figure 1. The histogram of fraction of technical personnel in manufacturing is shown in Figure 2. There is a wide distribution of where technical personnel are assigned within the sites (particularly visible from the distribution of technical personnel in manufacturing) suggesting one or more of the following scenarios across the sites that completed the survey:
  • Different role definitions for pers-onnel within the technical areas
  • Structural differences between sites necessitating different distributions of personnel
  • Different priorities and/or focus of the site management
  • Lack of understanding regarding optimal distribution of technical personnel.

Site-level drivers of change

Figure 3: Experienced and expected drivers of quality activities and resources.
Each site was asked to identify significant sources, or drivers, of changes in quality efforts and activities at their site. The respondents indicated whether specific drivers had been experienced by the site in the past and/or are anticipated drivers for the site in the future. The results from the survey of the sites are presented in Figure 3, ordered from left to right in descending order of fraction of sites identifying the type of driver as one that has been experienced in the past. Of particular note are the following findings:
  • The two types of drivers most frequently experienced were technical challenges (i.e., process, material, equipment) and regulatory challenges (i.e., change from the regulator, noncompliance).
  • Drivers potentially directly related to profitability of the product (e.g., cost reduction and pursuit of new markets) have been infrequently experienced.
  • Drivers expected to be experienced significantly more in the future than the past are those directly related to profitability including pursuit of new technology, cost reduction, and pursuit of new markets.
  • The number of types of drivers expected to be experienced per site is significantly higher than the number of types of quality drivers historically experienced per site, increasing from an average of 40% to 60%. For example, sites expect to have more drivers of change in quality approach and activities and/or have different outcome priorities (e.g., cost reduction and anticipated regulatory change) in the future compared with the past.

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