We usually focus on the following two tools:

• Process FMEA – The process Failure Modes and Effects Analysis is a systematic method used to identify and assess potential failures in a manufacturing or assembly process. This has to be done based on the factory’s plan if the product has not been industrialized yet.
  If production is already underway, our engineer will walk the factory floor with relevant stakeholders from the manufacturer to observe and evaluate each step, finding potential issues. They will rank them by severity, possible rate of occurrence, and how likely detection will be. The factory can then concentrate on fixes for the most serious issues.
  You can see an example process FMEA here that shows the process, failure modes, and risk assessment for each:
• Control Plan – This plan collects and shows the steps needed for consistent quality and results from the production process. It includes process controls such as checking that a machine is operating properly, product controls such as performing incoming QC, what needs to be measured, and more.
  The plan will be a foundation of the work instructions given to operators. It also feeds the factory’s plan for quality checks throughout the manufacturing cycle.
  Here’s an example of part of a control plan, in this case for machined parts:

The process FMEA is started first, and then if time and our client’s budget allow we start documenting the control plan. In a way, these two tools feed into each other.

• It can be very intensive, every morning for 3 to 5 days in a row, or less intensive with 1 or 2 days between each workshop.
• The following people typically need to attend and actively participate: a quality engineer, a process engineer, the salesperson and/or project manager, someone from the manufacturing team, and if possible someone from purchasing (or, ideally, a supplier quality engineer)
• To be provided before the first day, in case there were already pilot runs or mass production batches: list of the main quality issues that were found so far
• To be provided before the first day, in case there is information about a relatively similar type of product made at that same factory: a list & analysis of the main quality issues in that other product
• First day: visit the manufacturing area for 30 to 60 minutes, then short training and workshop to start filling out the process FMEA form. In the afternoon (after the workshop), more information-gathering and documentation work
• Following days: workshop on the process FMEA analysis and its associated to-do list, and start on a process control plan as time permits (note: the collaboration and support from the manufacturer’s side determine the amount of progress that can be made, for the most part)
• Gradual transition into defining the control plan, depending on progress made on the FMEA