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