Activity

  • One of the changes that occurs in my company is the managing of the bill of materials (BoM). Whenever a general change control is carried out, it must include a justification as to why the change is being implemented as well as the consent from all participating members via a signed approval. An example of a change control that recently occurred in my company was adding a 2.5 liter light-proof bag to a BoM designated for the manufacturing of a cell-based infusion product. The justification for initiating this change followed the discovery that cell media was photo-sensitive and would degrade in quality when exposed to light for prolonged periods, thereby compromising the quality of every affected lot. Once the change request was put into place, it required the approval of the on-site supply chain manager, the PM, all manufacturing managers, and secondary participants at the most convenient change control meeting.

    Ideally, a project should contain as few changes as possible with any required changes occurring as early as possible. Since a BoM is directly related to the manufacturing process, it should be properly managed so that it sees as few revisions as possible. An online search of BoM management provides a list of guidelines to ensure that this stage of the design process runs as smoothly as possible (1). One guideline involves automating a BoM by applying a quality management software to generate and keep track of the list of supplies/materials that make up a BoM, thereby minimizing human error. Another tip is to monitor contracts with vendors to ensure that all agreements do not expire halfway through a phase, unless a supplier is performing unsatisfactory. What other proactive steps can a PM take to reduce the number revisions in a BoM? Will a change in the BoM result in the change of any other documents, perhaps the standard operating procedures (SoPs)? How is a change control board selected being that it should involve input from every department?

    References
    (1) Industry Star Solution website