NYX Level 3 Layered Process Audit

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

• Select date

  Date

Manufacturing

• House keeping: Plant walk through to verify plant cleanliness inside and outside.<br>Are aisles clear?<br>Oil in the floor?<br>Plastic pellets on the floor?<br>Part not stored on top of flammable storage cabinets.

  Yes

  No

  N/A

• All items not necessary to performing work are removed from the workplace; only tools, fixtures, gages and products are present at work stations.

  Yes

  No

  N/A

• Are the fire exits and extinguishers not blocked? Is fire extinguisher PM completed as per schedule along with monthly visual inspection?

  Yes

  No

  N/A

• Are spill kits present as per the evacuation plan and are all contents present in the spill kits?

  Yes

  No

  N/A

• Are returnable containers at the press clean and previous labels removed?

  Yes

  No

  N/A

• Is the material concentrate sealed to protect from contamination? (Look for covered containers)

  Yes

  No

  N/A

• Is the waste properly disposed of as per the waste disposal instruction at press? (Verify plastic scrap is disposed in the red bin, rags are disposed in the rag container, paper is disposed in the marked recyclable container, cardboard disposed in the cardboard containers)

  Yes

  No

  N/A

• Are the correct material, color concentrate, and components being used as per Control Plan? (Compare the Material Identification Tag Color Codes and Component part # to the BOM and Control Plan)

  Yes

  No

  N/A

• If ran by concentrate, is the mix ratio correct and recorded? (Verify mix ratio on the FPA and color concentrate setup sheet (if applicable) with the Control Plan)

  Yes

  No

  N/A

• Are all applicable sections on FPA sheet completed and signed by appropriate personnel? (Look for signatures of all appropriate personnel and the date)

  Yes

  No

  N/A

• Does the Material Handler, Team Leader, Quality Inspector and Supervisor know when FPA is required?

  Yes

  No

  N/A

• Is the packaging instruction available and parts packed per the packaging instruction?

  Yes

  No

  N/A

• Are all parts and/or components in a designated area?

  Yes

  No

  N/A

• Is the date wheel on the part or on the part label correct?

  Yes

  No

  N/A

• Does the process setup exist and is it approved by the process engineer? Is the mold # and press # on the setup sheet and are they accurate?

  Yes

  No

  N/A

• Does the process verification sheet exist and is it being used? Is change history being recorded? (All 3 shifts) (verify current process parameters with master setup sheet. Verify process verification sheet and process change log)

  Yes

  No

  N/A

• Does the current cell layout match the master cell layout? (Fixtures, conveyors, scrap bins, finished containers, ect) Compare actual cell layout to master cell layout)

  Yes

  No

  N/A

• Does the tool, fixture, gage have the customer property tag identification?

  Yes

  No

  N/A

• Is the tool PM completed as per the schedule?

  Yes

  No

  N/A

• Is any equipment or machines which are not in use turned off?

  Yes

  No

  N/A

• Are the level 1 layered audits performed as per schedule? And all issues from level 1 closed?

  Yes

  No

  N/A

• Do MOS for manufacturing (mold repair cost, earned hours, scrap, solid waste, energy reduction) exist, are they updated and posted on MOS board?

  Yes

  No

  N/A

• Is the MOS (mfg) goals are not met, is there an action plan and are the open issues closed on time?

  Yes

  No

  N/A

Maintenance

• Have the daily/weekly/monthly/quarterly/semi-annual and annual maintenance checks been completed for all the equipment that effects quality, safety and the environment and are the records available? (Verify maintenance records for press, robot, assembly fixture, crane, Hilo, sprinkler system, conveyor, infra red test, ect)

  Yes

  No

  N/A

• Does the fixture appear to be working properly including error proofing? (Verify assembly fixture verification completed and error proofing verified per shift. Parts should be available for all failure modes to verify the fixture is working. Rabbit parts should be marked "red" to ensure they are not mixed)

  Yes

  No

  N/A

• Are all chemicals (spray bottles and containers) used in the work area labeled with HMIL label, and stored at designated area? (Look for chemical spray bottles or containers having appropriate identification HMIL labels and all flammable containers stored in the flammable cabinet)

  Yes

  No

  N/A

Human Resource

• Safety: is the employee wearing appropriate PPE (personal protective equipment) like safety glasses, cut proof gloves if trimming, hearing protection, hair nets (if applicable)?

  Yes

  No

  N/A

• Does the operator know the location of the first piece and purpose of the first piece? (First piece should be used as a master)

  Yes

  No

  N/A

• Does the operator know about and has been trained on the Quality Alerts? (Need to have operator signature on the Quality Alert)

  Yes

  No

  N/A

• Is the operator performing the job as per operator instructions and do they know where their instructions are? (Review 3 parts being built to see if operator is building in sequence to the Operator Instruction)

  Yes

  No

  N/A

• Does the employee know the "NYX Policy" statement and know the meaning of it?

  Yes

  No

  N/A

• Is the employee aware of their Quality and Environment objectives, status of the objectives, and how they support achievement of these objectives?

  Yes

  No

  N/A

• Does the employee know what we are recycling and why?

  Yes

  No

  N/A

• Is the employee trained for a specific job and shown as "trained" on employee training matrix? (Verify training matrix"

  Yes

  No

  N/A

• Does the employee know what to do in case of fire? (Ask questions and verify if they know where the nearest exit is)

  Yes

  No

  N/A

• Does the employee know what to do in case of a tornado? (Ask if they know where the tornado shelter is)

  Yes

  No

  N/A

• Does the employee know what to do if there is a spill? (Ask them what do they do if a spill occurs that they cannot contain)

  Yes

  No

  N/A

• Does the employee know what to do in case of any chemical reaction/burn on their skin or if the inhale it?

  Yes

  No

  N/A

• Does the employee know the location of eye wash station, first aid kit and MSDS book?

  Yes

  No

  N/A

• Does the operator know what to do in case defective parts are running and what to do with the defective parts? (Turn the red andon light on and place defective parts in the red bin)

  Yes

  No

  N/A

• Does the operator know how to fill out the production sheets and record on the production board? (Look for the daily production sheet for completion and verify count on the production board)

  Yes

  No

  N/A

• Are all personnel performing inspections properly trained /qualified? (Review inspection personnel qualification and training records)

  Yes

  No

  N/A

• Is the appropriate training completed for any document changes, ECN changes, Control Plan and operator instruction changes if applicable? (Verify training records)

  Yes

  No

  N/A

• Are MOS for human resources (effectiveness of training, # of incidents or accidents, employee satisfaction) exists, updated and posted on MOS board?

  Yes

  No

  N/A

• If the MOS board (HR) goals are not met, is there an action plan and are the open issues closed on time?

  Yes

  No

  N/A

• No outdated, torn, or soiled announcements are displayed. All bulletins are arranged in straight and neat manner.

  Yes

  No

  N/A

Quality

• Is the job book present at the press and the documents the current revision level? ( verify revision date of current documents and engineering change level to the print)

  Yes

  No

  N/A

• Does the part # on label match with Control Plan?

  Yes

  No

  N/A

• Do the quality of parts running at the press match with the quality of the first piece? First piece and last piece present? (Compare sample part from the press with the first piece)

  Yes

  No

  N/A

• Is the daily inspection log completed properly? (Verify all sections - man, material, machine, method, product of the daily inspection log)

  Yes

  No

  N/A

• Does the inspection criteria and frequency of inspection checks match the control plan? (Verify control plan inspection criteria)

  Yes

  No

  N/A

• Is the reaction plan appropriate for the inspection findings? (Verify daily inspection log and reaction plan for any non conformance)

  Yes

  No

  N/A

• Does the inspector know the current quality alert (if applicable) and is there any quality alert posted that have expired? Question should be asked to Quality Inspector about current quality alert and verify signature of the inspector on the quality alert. Verify if the quality alert expired.

  Yes

  No

  N/A

• Is the inspection status showing on the container? (Look for inspection status on the container like inspector stamps with initials, GP-12 stickers, certification stickers, ect if applicable)

  Yes

  No

  N/A

• Does the checking fixture exist and is it listed on the control plan? Is it calibrated? Are calibration results verified before and after calibration? If ran out of calibration condition before or after condition are proper actions taken?

  Yes

  No

  N/A

• Is the receiving inspection performed as per "Receiving Inspection Status"? (Need to have inspection results for "red" and "yellow" status.

  Yes

  No

  N/A

• Are critical characteristics of received materials being monitored?

  Yes

  No

  N/A

• Are all non-conformances identified, segregated and dispositioned appropriately? (NC products should be tagged with "hold" label and segregated from production area and a NCMR must be generated for the product. The hold area must be clean and organized)

  Yes

  No

  N/A

• Is the PPAP approved for the job that is running? (Verify the PPAP status on the master job list and part submission warrant)

  Yes

  No

  N/A

• Does the engineering change level and date match the approved PPAP? (Verify eng change level on the assembly drawings and component drawings)

  Yes

  No

  N/A

• Are the product audits being completed as per the schedule and reported to the Quality Manager immediately for any failure of inspection?

  Yes

  No

  N/A

• Are the level 2 layered process audits performed as per the schedule?

  Yes

  No

  N/A

• Is the QPR log updated for all the concerns and verify implementation of the corrective action? And appropriate documents Control Plan, PFMEA, operator instruction, BOM, cell layout, error proofing matrix, process setup sheet, ect updated as per the corrective actions if applicable. <br><br>Is read across matrix updated for all the concerns?

  Yes

  No

  N/A

• Is the master job list updated for all the current ECNs and new tool #s and all appropriate documents updated?

  Yes

  No

  N/A

• Do the MOS for Quality (customer PPM, system compliance audit, product SQPM, customer rejections, supplier PPM) exist, are they updated and posted on MOS board?

  Yes

  No

  N/A

• If the MOS (quality) goals is not met is there any action plan? Were the open issues closed on time?

  Yes

  No

  N/A

Materials

• Are all part numbers arranged per plan (one part per row and the row identified)?

  Yes

  No

  N/A

• Is (FIFO - first in / first out) system being used? (Verify the mfg date at the beginning and end of rows of finished products)

  Yes

  No

  N/A

• Are parts stored in the warehouse as per packaging instruction?

  Yes

  No

  N/A

• Are all the containers in WIP area, purchased products area, finished goods area found "ok" condition and are not damaged?

  Yes

  No

  N/A

• Do shipping personnel verify the order against the pick list?

  Yes

  No

  N/A

• Do MOS for materials (premium freight, inventory turns, on time delivery) exist, are they updated and posted on MOS board?

  Yes

  No

  N/A

• If the MOS (mat) goals are not met, is there an action plan and are the open issues closed on time?

  Yes

  No

  N/A

Management

• Are the daily meetings being conducted and resolved through action items if applicable?

  Yes

  No

  N/A

• Does management review, at least quarterly, the following items and are the action plans developed based on the review. Are the action items closed on time?<br><br>A) Continuous Improvement<br>B) Resource Review and Organization Changes<br>C) Status of corrective and preventative actions<br>D) ECN Review<br>E) SPC Review<br>F) Cost of Quality<br>G) PM Status<br>H) Calibration Status<br>I) Capacity Review<br>J) Review of System Audits / Follow ups

  Yes

  No

  N/A

• Add signature

  Sign