Services: Process Monitoring
is Process Monitoring?
Process monitoring is an effective tool used to maintain control of a manufacturing
operation, as well as demonstrating ongoing compliance to specifications.
Once the qualification and/or validation exercises are completed, a baseline
cleanliness reference can be established. By executing scheduled monitoring
of the process during normal operation, the control limits can be checked
to insure the process remains within the defined boundaries. Process monitoring
programs are focused on production product with stable build schedules.
Often, when Foresite re-establishes a client's process that has experienced field
service failures, monitoring is required by the end customer to insure the
fault condition does not re-occur.
The Process Monitoring Program is exercised on a specific product, process
sequence, and material list defined at the beginning of the monitor period.
The goal of the program is to quickly identify deviation from the baseline
performance. Thus, no testing of other products, processes, or materials
can be inserted into the monitor program.
Ion Chromatography (IC) analysis is applied in process monitoring by
comparing IC results to data recorded with the customers existing ROSE
testing system, establishing a baseline performance threshold, and providing
an ongoing validation of performance via periodic sample checks of product.
IC is a very effective tool when used to check the consistency of incoming
Foresite engages in consultation with each customer prior to any activity
to identify project goals, design an applicable test matrix, and provide
technical information derived from our experience and knowledge of contamination
effects on product reliability.
Initial Report — contains deliverables
identified in Qualification and/or Validation service
Monitor Report — monitoring interval
and report generation established at time of quote
Foresite Monitor Report Deliverables
Qualification and/or validation of process must be established prior to monitor program.
Monitor Program requires an open Purchase Order to Foresite for billing
at monitor intervals.
- Account of samples sent, production lot record, date of analysis
- Performance chart showing baseline reference versus current results
- Trend charts showing monitoring history at specified intervals
- Identification of residues present - ionic data indicating type and amount
- Foresite cleanliness limit recommendation for each ionic species identified
- Foresite interpretation of data and conclusions from our technical team
- Foresite recommendations for any process optimizations
- Formal monitor report electronically sent to customer project contact
- Original hard copy report mailed upon completion of each monitor exercise
- Telephone support included for discussion of each monitor report
The Foresite Approach to Process Monitoring
To provide the customer with the deliverables mentioned, monitor
samples are produced as part of normal production operations. These
samples will be sent to Foresite for evaluation and reporting. Proper handling
of the samples is critical to insure test samples are exposed only to
those contaminants resident in the process.
The following protocol is required for process monitoring programs:
Upon initiation of the program, Foresite will receive and hold bare laminate
to be used in the monitor program for the specified assembly. Foresite will
secure the integrity of the PCB's by sealing them in Kapak bags until
required by the monitor interval.
Foresite will ship two bare PCB's to the customer (build site) at the trigger
interval. These PCB's will be identified as "Process Monitor Samples" (marking
method to be determined with customer). Foresite will notify customer when
samples have been sent.
Customer executes a scheduled build including the two monitor samples.
Customer pulls a finished random unit from build and sends the three assemblies
to Foresite. No special procedures or handling precautions are to be taken
with these monitor samples to accurately represent the daily activities
of the production facility. Shipping and packing instructions will be
given to customer.
The following information must be provided to Foresite with each monitor batch:
Foresite will conduct the defined testing upon receipt of samples
- notification to Foresite that monitor samples have been sent (phone, fax, e-mail)
- identification on outside of package (MONITOR SAMPLES)
- packing list identifying contents (assembly number) and P.O. reference
- lot code information — customer coding previously defined
- date these samples were manufactured (plant identification may be required)
- information regarding any change in sequences from established baseline
Foresite will issue a Monitor Report for each lot tested
- Testing time completion established at beginning of program
- Foresite personnel will observe all ESD handling requirements
- All product will be returned to customer-designated contact
Customer-specific information must be provided to Foresite at start of program:
- Contents of Monitor Report identified at beginning of program
For the Monitor Program sequence, click here.
- Contact name — responsible for all aspects of monitor program (builds/reports)
- Phone numbers — (office, cell, pager, fax)
- Customer shipping number (FedEx, UPS)