Electronics Manufacturing PCBA Quality Process Audit — General Processing

1. Environmental and ESD Control
1.1Are there temperature & humidity sensors in the Manufacturing area to monitor temperature & humidity over time?
1.2Are there documented upper & lower specification limits for temperature and humidity to assure Paste viscosity, ESD & MSD control?
1.3Is there evidence to demonstrate that effective action was taken when the temperature/humidity was outside the defined limits?
1.4If AC Ground is used as Earth Ground for ESD purposes, is it clearly understood that AC Ground must be connected to a grounding rod?
1.5Is ESD Earth Ground impedance (grounding rod to earth) measured at least annually?
1.6Does the above measurement result comply with established specifications?
1.7Is either an ESD Conductive or Static Dissipative floor installed in the Manufacturing areas? ESD Matting also scores 0, except for 7 thru 10.
1.8Is there evidence that the floor was installed using conductive adhesive with copper earth grounding straps?
1.9Is there evidence that the floor is cleaned in accordance with the floor/coating manufacturer’s specification?
1.10Are fixed material storage racks for components/assemblies earth grounded?
1.11Do portable material storage racks for components/assemblies use conductive wheels or drag chains to contact the ESD floor?
1.12Are all machines ESD Earth Grounded?
1.13Are timed Resistance-to-Ground tests conducted using an ESD Meter to periodically evaluate ESD performance?
1.14Is there evidence that at least five tests are taken per 5000 square feet of production floor space?
1.15Is there evidence of periodic performance testing of the floor, fixtures, and all work and material storage surfaces in the ESD protective area?
1.16Are ESD protective areas appropriately marked and labeled?
1.17Is there evidence that anyone in the ESD protective area is required to wear ESD Smocks and two ESD Shoe Straps/ESD Shoes? Note*
1.18Is there evidence that anyone seated must use a wired ESD strap while handling components in addition to Shoe Straps/ESD Shoes?
1.19Is there evidence that the chairs used are ESD safe and are they in conductive contact with the floor?
1.20Is there evidence that Shoe Straps/ESD Shoes and wired wrist/ankle straps are tested each time ESD Protective items are garbed?
1.21Is there evidence that the materials used in operator tools inside the ESD protective area ESD safe?
1.22Is there evidence that Antistatic & Static dissipative material (usually pink) is not used outside the ESD area for component storage?
1.23Is there evidence that Static Shielded material (usually gray) is used outside the ESD area for component storage?
1.24Is 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
2.1Is a Forced Board Routing system and WIP Tacking system fully deployed throughout SMT, PTH and Test?
2.2Are all boards tracked through the process by serial number and is board history available for traceability purposes?
2.3Does the system verify the ‘last’ step processed and compare it to the expected ‘last’ step?
2.4Are quality performance or buffer trigger points established to ensure machine shut down should the limits be exceeded?
2.5Are line shutdown criteria clearly specified for both quality and buffer limiting requirements?
2.6Is there a documented checklist available and in use to ensure successful product changeover?
3. Machine Maintenance
3.1Is there a recommended Spare Parts list for the selected machine?
3.2Are on-hand stock quantities and minimum reorder points set and controlled using a database?
3.3Does the on-hand stock balance reflect the physical stock quantities for two samples taken?
3.4Are Daily Maintenance logs kept at the machine and are they up to date?
3.5Is a Preventative Maintenance System used to flag when periodic Preventative Maintenance is required?
3.6Is there evidence to demonstrate that Preventative Maintenance records are up-to-date?
3.7Are problem descriptions and their closure recorded and verified on the Daily and Preventative Maintenance logs?
4. Machine Operator
4.1Does the Operator have the Standard Operating Procedure (SOP) for the machine available to them at all times?
4.2Are WIs & SOPs free of hand written updates? Temporary hand written updates are OK if signed and dated with expiration date <48 hrs.
4.3Is there evidence that the Operator has been trained and certified against the Standard Operating Procedure for the Machine?
4.4Does 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.)
4.5Are Operators required to log in at the Machine station and does this provide an automatic verification of training status?
5. PCBA Inspector
5.1Is the Inspector required to wear gloves or finger cots when handling boards and do they wear them?
5.2Does 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.)
5.3Is there evidence that the Inspector has been trained and certified against the IPC-610 Standard and on component identification?
5.4Does the Inspector know the content of the IPC-610 Standard and are they able to read component identification markings?
5.5Are Operators required to log in at the inspection station and does this provide an automatic verification of training status?
5.6Do quality inspectors have access to sampling plans (e.g. ANSI, MIL, ASQ) at all times?
5.7Does the quality inspector know the sampling plan and switching rules for increased/decreased sample sizes?
5.8Does quality inspector have access to product specific reference tools, (e.g. golden unit, templates)?
5.9Is there evidence that quality inspector has been trained/certified in basic quality practices and statistics/SQC?
6. Chemical Compatibility
6.1Is there a master matrix which outlines the Chemical Compatibility for solder wire, fluxes, flux pens, cleaning solutions, etc?
6.2Was a study conducted to assure the chemical compatibility of the consumables on the list and is it available?
6.3Are specifications readily available for the various types of solder, flux, cleaning agents, etc. being used?
6.4Are Chemical Industry standard labeling used to identify all chemicals used, e.g. flux, alcohol, etc?
7.Programmed Parts
7.1Are 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)
7.2Are component part numbers and their descriptions specified on Work Instructions?
7.3Are component descriptions sufficiently detailed to ensure the correct blank component is being used?
7.4Are label part numbers identified and a drawing/picture of the label contents included on the Work Instruction if labels are required?
7.5Is the orientation of the label on the component consistent and does it include the correct checksum information if required?
7.6Are parts only labeled post programming with the program information if such info is required as per Dell’s specification drawings?
7.7Is there evidence to demonstrate that programmed parts are clearly segregated from unprogrammed parts?
7.8Is the Master Program name/number and revision indicated on the Work Instructions and traceable to the current PCBA revision?
7.9Do Work Instructions indicate the orientation for loading blank components into the programmer?
7.10Are the Moisture Sensitive Devices (MSDs) readily known to the operator?
7.11Are MSDs time stamped at opening and their exposure time recorded as a result of programming?
7.12Can MSD control, according to J-STD-033A,l be demonstrated for MSD devices that need programming?
7.13Is the orientation of programmed parts in their packaging preserved before and after programming?
7.14Is there evidence that a defined process for non-conforming material such as damaged, failing or programmable parts is in operation?