Want 40% faster cycle times with 90% less scrap?
It's not a Injection Mold tryout, it's a Process Validation, most do not follow a process validation, they follow Tooling validation and with that you have a mold that has been validated able to produce acceptable parts. What you don't have is a process that will make an acceptable part every time within the required limits.
Honestly in my 20+ years experience, and 1000’s of tryouts I have only seen twice a mold validation being performed to qualify the process. Most FDA regulated molders, the validation process is a requirement for RA, however in automotive and consumer goods.. it is rare... Why?
How to know if you validated the process?
Did you use the tools listed below?
Process validation can be broken down into 3 steps: process design, process qualification, and continued process verification.
Design of Experiment (DOE)“Design of experiments is used to discover possible relationships and sources of variation as quickly as possible. A cost benefit analysis should be conducted to determine if such an operation is necessary.”
Quality by Design (QBD) This should be applied to all Critical Molding processes when in fact simple design modification can eliminate many future Y variables (Risk Assessment)
“Quality by Design is an approach to pharmaceutical manufacturing that stresses quality should be built into products rather than tested into products; that product quality should be considered at the earliest possible stage rather than at the end of the manufacturing process. Input variables are isolated in order to identify the root cause of potential quality issues and the manufacturing process is adapted accordingly.”
Process Analytical Technology (PAT)“Process Analytical Technology is used to measure critical process parameters (CPP) and critical quality attributes (CQA). PAT facilitates measurement of quantitative production variables in real time and allows access to relevant manufacturing feedback. PAT can also be used in the design process to generate a process qualification.”
Critical Process Parameters (CPP)“Critical Process Parameters Operating parameters that are considered essential to maintaining product output within specified quality target guidelines.”
Critical Quality Attributes (CQA)“Critical Quality Attributes are attributes that are considered essential in determining product quality.”
Design Space Verification“Design Space Verification confirms that quality can be guaranteed within an identified range of input and operating variables.”
Process Qualification“In this stage the process design is assessed to conclude if the process is able to meet determined manufacturing targets. In this stage all production processes and manufacturing equipment is proofed to confirm quality and output capabilities. Critical quality attributes are evaluated and critical process parameters taken into account to confirm product quality. Once the process qualification stage has been successfully accomplished production can begin. Process Qualification is the second phase of process validation.”
Continued Process Verification“Continued Process Verification is the ongoing monitoring of all aspects of the production cycle. It aims to ensure that all levels of production are controlled and regulated. Deviations from prescribed output methods and final product irregularities are flagged by a process analytics database system”
Here's a rule for you to remember, If you don't do a DOE then you didn't qualify the process
What are the benefits?
Average of 40% faster cycle times
90% less scrap. which is a triple play material plus plus savings
Twice as many unattended hours
Much higher PPE Turnover
Whats does it cost to implement? Well if you're not following this process you are already paying for it 3 fold.