When a product is launched in a factory that has never made it before it is important to start making it in small quantities to confirm that the production processes, people and equipment, as well as the testing stations, are capable of making your products at the expected quality and speed. Those batches are usually called pilot runs, or process validation runs. This is where the production readiness review by our engineers occurs.
The more complex the product and the “newer” it is for that factory, the more important those pilot runs are because new productions are inherently riskier due to a lack of familiarity and practice.
Sofeast supports you to have the peace of mind that everything is running well and ready for mass production by performing this production readiness review before you give the green light to release large amounts of materials into manufacturing.
Our engineer goes on-site to your supplier’s factory around the time they say they’re almost ready to start mass production and checks if they are truly ready to start production with the minimum of risks.
Ideally, it takes place during a pilot run, on the same production lines, with the same people and the same equipment as mass production. If the manufacturer is not planning to do a pilot run, it takes place just before the first batch starts, and depending on the situation and the risks to cover it may last for a few days.
When it comes to most assembly operations we’ll generally check the following points for you:
- Training – Have operators been trained and do they have clear and simple work instructions and an understanding of your quality standard?
Are the process engineers clear and confident on all processes (any not obvious, not easy, tiring…) and have they already made some prototypes before?
Do testers and inspectors have a clear quality standard and have been trained to it?
Testing jigs are ready and have been tested on good and bad products with clear and obvious results?
- Assembly line setup – Is there enough capacity for your planned order size and its schedule?
Has the work been broken down into several operations to be done on a line which is more productive than it remaining in one place with different people bringing materials to it?
Will the materials flow one piece at a time?
Are operators likely to keep semi-finished products together at their stations which risks getting them mixed up?
Will all assembly, testing, packing, and inspection jobs be done on the same line (or connected lines), or will they have to be transported across the factory?
Are nonconforming materials segregated from the rest of them, for example in red containers?
- Materials delivery to the line – Are the production materials and packaging available on site? If not, is this being followed up on and are there issues to be concerned about?
Will materials need to be prepared (e.g. kitted) before delivery from the warehouse to save on space at the lines?
Are production operators replenished by logistics staff so they don’t have to pause working to obtain more materials?
- Management – Has the production control planner done their plan based on standard times that were set up for this product?
Will scrap and rework be accounted for?
Is the line leader trained, with a good understanding of the operations and the quality standard?
These points give you a fairly good idea of what we examine during a production readiness check in order for you to be confident to give the green light to your supplier.
However, what we check depends on the situation we find. Typically, the manufacturer cannot give a very precise timing estimate, since those validation runs are meant to uncover issues… which can block manufacturing and take time to address & fix.
It means we have to be flexible and check what can be observed and analyzed on our visit.
Here are a few examples.
- The factory may have already started assembling, testing, and maybe even packing the final product, and we can review all those processes. We can estimate capacity at that point in time, as well as the first pass yield. We point to the critical & major issues that need to be addressed.
- In many cases, production gets suspended or cannot even start because of a blocking issue at one process. We can go over the main issues and discuss them with factory representatives. We can review the factory’s incoming, in-process, and outgoing inspection approaches, including measuring instruments calibration, etc.
- In some cases, the factory is quite behind schedule, and we are left to check some of the critical components that have already arrived. We review the factory’s incoming QC approach. And we draw a list of the most common defects in the components.
We work with you and with the manufacturer to adjust the schedule so that our presence in the factory brings you the most benefits.
Yes, it can. When this is part of a program, we usually start with a factory audit, and then come back several times during the initial small run(s) and then later as mass production scales up. We keep track of the issues found and we follow up, noting which ones got successfully closed. This is a good way to push the manufacturer to work on the most severe issues in priority, and it gives the customer an informed idea about the level of quality and capacity they can expect.
If you are quite serious about improving the supplier’s quality systems, consider doing this as part of a layered factory auditing program.
This check is especially relevant when you’re starting production of a new product that hasn’t been manufactured before, or you’re using a new supplier to manufacture an existing product for the first time. In these cases, the risks of mistakes happening during production are higher due to the unfamiliarity with the product and its processes.
It is reported in a structured way, based on our proprietary checklists. We highlight what we see as the most severe issues that are likely to prevent a smooth transition into mass production, from a quality perspective, and also from a capacity perspective.
The production readiness review helps assure you that mass production can start with a minimum of risks, but, after production starts, we can also do a First Article Inspection for you where our QA technician performs a thorough inspection of the first pieces off of the production line (or out of tooling) against your requirements. This prevents issues from being repeated in large numbers during production.
What does it cost?
The production readiness review starts from US$299 (for 1 day).
For best results, it lasts 2 to 4 days. Costs vary based on the factory location and based on your needs, and we will provide a tailored quote for you.