|1. Environmental and ESD Control
|Are there temperature & humidity sensors in the Manufacturing area to monitor temperature & humidity over time?
|Are there documented upper & lower specification limits for temperature and humidity to assure Paste viscosity, ESD & MSD control?
|Is there evidence to demonstrate that effective action was taken when the temperature/humidity was outside the defined limits?
|If AC Ground is used as Earth Ground for ESD purposes, is it clearly understood that AC Ground must be connected to a grounding rod?
|Is ESD Earth Ground impedance (grounding rod to earth) measured at least annually?
|Does the above measurement result comply with established specifications?
|Is either an ESD Conductive or Static Dissipative floor installed in the Manufacturing areas? ESD Matting also scores 0, except for 7 thru 10.
|Is there evidence that the floor was installed using conductive adhesive with copper earth grounding straps?
|Is there evidence that the floor is cleaned in accordance with the floor/coating manufacturer’s specification?
|Are fixed material storage racks for components/assemblies earth grounded?
|Do portable material storage racks for components/assemblies use conductive wheels or drag chains to contact the ESD floor?
|Are all machines ESD Earth Grounded?
|Are timed Resistance-to-Ground tests conducted using an ESD Meter to periodically evaluate ESD performance?
|Is there evidence that at least five tests are taken per 5000 square feet of production floor space?
|Is there evidence of periodic performance testing of the floor, fixtures, and all work and material storage surfaces in the ESD protective area?
|Are ESD protective areas appropriately marked and labeled?
|Is there evidence that anyone in the ESD protective area is required to wear ESD Smocks and two ESD Shoe Straps/ESD Shoes? Note*
|Is there evidence that anyone seated must use a wired ESD strap while handling components in addition to Shoe Straps/ESD Shoes?
|Is there evidence that the chairs used are ESD safe and are they in conductive contact with the floor?
|Is there evidence that Shoe Straps/ESD Shoes and wired wrist/ankle straps are tested each time ESD Protective items are garbed?
|Is there evidence that the materials used in operator tools inside the ESD protective area ESD safe?
|Is there evidence that Antistatic & Static dissipative material (usually pink) is not used outside the ESD area for component storage?
|Is there evidence that Static Shielded material (usually gray) is used outside the ESD area for component storage?
|Is there evidence that periodic Static Audits are conducted to verity the ESD grounding system deployed in the ESD area?
|2. Line Set-Up and Control
|Is a Forced Board Routing system and WIP Tacking system fully deployed throughout SMT, PTH and Test?
|Are all boards tracked through the process by serial number and is board history available for traceability purposes?
|Does the system verify the ‘last’ step processed and compare it to the expected ‘last’ step?
|Are quality performance or buffer trigger points established to ensure machine shut down should the limits be exceeded?
|Are line shutdown criteria clearly specified for both quality and buffer limiting requirements?
|Is there a documented checklist available and in use to ensure successful product changeover?
|3. Machine Maintenance
|Is there a recommended Spare Parts list for the selected machine?
|Are on-hand stock quantities and minimum reorder points set and controlled using a database?
|Does the on-hand stock balance reflect the physical stock quantities for two samples taken?
|Are Daily Maintenance logs kept at the machine and are they up to date?
|Is a Preventative Maintenance System used to flag when periodic Preventative Maintenance is required?
|Is there evidence to demonstrate that Preventative Maintenance records are up-to-date?
|Are problem descriptions and their closure recorded and verified on the Daily and Preventative Maintenance logs?
|4. Machine Operator
|Does the Operator have the Standard Operating Procedure (SOP) for the machine available to them at all times?
|Are WIs & SOPs free of hand written updates? Temporary hand written updates are OK if signed and dated with expiration date <48 hrs.
|Is there evidence that the Operator has been trained and certified against the Standard Operating Procedure for the Machine?
|Does the Operator know the content of the Standard Operating Procedure for the Machine and do they and follow it? (Score 1 if the operator has not memorized the contents, but can quickly reference the SOP to answer the auditors questions.)
|Are Operators required to log in at the Machine station and does this provide an automatic verification of training status?
|5. PCBA Inspector
|Is the Inspector required to wear gloves or finger cots when handling boards and do they wear them?
|Does the Inspector have the IPC-610 standard available to them at all times? (Score 1 if a copy of IPC 610 is available in the general area.)
|Is there evidence that the Inspector has been trained and certified against the IPC-610 Standard and on component identification?
|Does the Inspector know the content of the IPC-610 Standard and are they able to read component identification markings?
|Are Operators required to log in at the inspection station and does this provide an automatic verification of training status?
|Do quality inspectors have access to sampling plans (e.g. ANSI, MIL, ASQ) at all times?
|Does the quality inspector know the sampling plan and switching rules for increased/decreased sample sizes?
|Does quality inspector have access to product specific reference tools, (e.g. golden unit, templates)?
|Is there evidence that quality inspector has been trained/certified in basic quality practices and statistics/SQC?
|6. Chemical Compatibility
|Is there a master matrix which outlines the Chemical Compatibility for solder wire, fluxes, flux pens, cleaning solutions, etc?
|Was a study conducted to assure the chemical compatibility of the consumables on the list and is it available?
|Are specifications readily available for the various types of solder, flux, cleaning agents, etc. being used?
|Are Chemical Industry standard labeling used to identify all chemicals used, e.g. flux, alcohol, etc?
|Are revision controlled Work Instructions displayed for the operator at the programming station? (Score 0 if any unsigned/undated handwritten instructions or any handwritten instructions more than 48 hrs old)
|Are component part numbers and their descriptions specified on Work Instructions?
|Are component descriptions sufficiently detailed to ensure the correct blank component is being used?
|Are label part numbers identified and a drawing/picture of the label contents included on the Work Instruction if labels are required?
|Is the orientation of the label on the component consistent and does it include the correct checksum information if required?
|Are parts only labeled post programming with the program information if such info is required as per Dell’s specification drawings?
|Is there evidence to demonstrate that programmed parts are clearly segregated from unprogrammed parts?
|Is the Master Program name/number and revision indicated on the Work Instructions and traceable to the current PCBA revision?
|Do Work Instructions indicate the orientation for loading blank components into the programmer?
|Are the Moisture Sensitive Devices (MSDs) readily known to the operator?
|Are MSDs time stamped at opening and their exposure time recorded as a result of programming?
|Can MSD control, according to J-STD-033A,l be demonstrated for MSD devices that need programming?
|Is the orientation of programmed parts in their packaging preserved before and after programming?
|Is there evidence that a defined process for non-conforming material such as damaged, failing or programmable parts is in operation?