• Process

  • Cell / Line

  • Shift

  • Part Number

  • Conducted on

  • Conducted by

  • Facility


  • The ArtiFlex Manufacturing Process Audit requires that the auditor have a copy of the Manufacturing Control Plan and Process FMEA. Although these may not be part-specific, these documents are the basis for many of the questions in the audit.

    Some items in the audit cannot be verified at the work station. The auditor will be asked to list employees working at the line or cell by name and clock number. It is then necessary to verify training and competency records. In a similar fashion, gage calibration records and document status must be carried out once the audit on the shop floor is completed.

    The Manufacturing Process Audit is to be performed on all shifts where the process is performed. The proper way to do this is to complete a separate audit for each shift. The reasoning behind this is that this is an audit of the process, not the people carrying it out. If there are differences among the people, it is the result of training, how the process has been designed, or how it is managed.

A1.0 Control of Documents

  • Check this box for an explanation of the Control of Documents Section.

  • TS requires that documents in the Quality Management System are controlled in their distribution to ensure that people are working according to what Management has determined is acceptable. For the majority of our documents, we can identify them by a two- or three-letter prefix, followed by a period and three numbers - like "QA.090." While at the work center, the Auditor is to record all documents that are in use. There are options for entering this Document Control Number (DCN) or recording the title and taking a photo of the document.

    Another part of this section deals with the PFMEA for the part - if there is one. The Auditor is offered the opportunity to check a box to display those questions only if there is a PFMEA available.

    Finally, there are some general questions regarding work instructions for the process, process parameters, and others.

  • A1.1 List all documents used and / or posted in the area. If a document does not bear a document control number, be sure to photograph it.

  • A1.1.
  • DCN (Document Control Number)

  • Revision Date

  • Check if no Document Control Number (DCN) is present.

  • Provide a title if one is present.

  • Photograph the document.

  • A1.2 After comparing all documents entered, determine are sampled Documents at the appropriate revision level?

  • A1.3 Are sampled Documents under appropriate document control?

  • A1.4 Check if there is a part-specific or generic PFMEA / Manufacturing Control Plan.

  • A1.4.1 Do the ranks listed on the PFMEA match the Standard PFMEA Risk Rankings?

  • A1.4.2 Do the process steps on the Process Flow Diagram, PFMEA and Process Control Plan match the current process as it is performed?

  • A1.4.3 Has the PFMEA been updated to include steps to prevent recurrence of nonconforming product identified from corrective actions?

  • A1.4.4 Do operator instructions correspond with the Process Control Plan?

  • A1.4.5 Are all of the columns labeled “Current Process Controls” listed on the PFMEA detailed on the Process Control Plan?

  • A1.4.6 Are special characteristics called out on the Process Control Plan with gaging, sample size, frequency?

  • A1.5 Are operator instructions available for each operation and available at point of use, including handling of nonconforming parts?

  • A1.6 Are job set-up parameters / instructions available and controlled?

  • A1.7 Are instructions for handling Work In Process well documented and followed?

  • A1.8 Obtain the Customer-Specific Requirements Review Report (see Quality Management Representative). This report is a record of verification of the active search for current customer-specific requirements. Are all reviews current (less than 1 week past due date)?

  • A1.9 Comments regarding Document Control

B1.0 Manufacturing Process

  • Check this box for an explanation of the Manufacturing Process Section.

  • TS requires various that production takes place under controlled conditions. These questions deal with those required production controls. Any weaknesses in this area can lead to the production and / or shipping of nonconforming product.

  • B1.1 Is there a process to ensure that the correct product and quantities are produced to meet customer requirements?

  • B1.2 Is there a process to ensure job set-ups are verified (e.g., 1st piece inspection, OK to Run, etc.)?

  • B1.3 If a master sample part is used on the production floor, does the revision level of the production part match the revision level of the master sample part?

  • B1.4 Do the sample size and frequencies used for inspection match what is stated on the Manufacturing Control Plan? (If there is no Manufacturing Control Plan, respond with 'No.')

  • B1.4.1 Are described tests and inspections actually performed as stated?

  • B1.4.2 Does sampled paperwork indicate that the product meets all specifications?

  • B1.4.2.1 Does the sampled paperwork show proper authorization for any deviation (e.g., customer approval, internal approval)?

  • B1.5 Where the Process Control Plan calls for SPC, is the data properly recorded?

  • B1.5.1 Are out of control points noted with the corrective action taken?

  • B1.6 Is product identified by suitable means throughout the manufacturing process?

  • B1.7 Is packaging and labeling correct as specified on the packaging instructions? (Note that approved secondary containers do count as being correct if noted in instructions.)

  • B1.7.1 Does the quantity in the container match the packaging instructions?

  • B1.7.2 Does the packaging and labeling meet all specifications including customer-specific requirements?

  • B1.8 If more than one shift, is there a process in place to communicate process issues from shift to shift?

  • B1.9 If a date stamp is used, is the correct date stamp on the part? (In Assembly cells, unless etched at the cell, the date stamp likely was created in the stamping. This question would then be 'N / A.")

  • B2.0 Comments regarding Manufacturing Process

C1.0 Calibration

  • Check this box for an explanation of the Calibration Section.

  • Measurements are only as good as the system in place to measure products and processes. Part of the requirement is that all measuring instruments are identified. So, much like documents, there is a section of the audit for listing many measuring instruments, check fixtures, etc. Unlike documents, these must all have an identification number.

    Calibration status must be verified in the Quality Lab for all instruments listed..

  • C1.1 List all measuring equipment (check fixtures, hand-held gages, weight scales, etc.) used at the Cell / Line.

  • C1.1.
  • .1 Gage ID (from calibration label. If no label, "None.")

  • .2 Photo of Calibration / Validation label (if no label, entire gage / fixture).

  • C1.2 After verifying status in Quality Lab, are measurement gages / checking fixtures available and properly identified and calibrated?

  • C1.2.1 Including employee owned gages?

  • C1.3 Are Customer-owned gages identified with ownership?

  • C1.4 Do complex checking fixtures have operator instructions available to ensure consistent use of the gage?

  • C1.5 Are all checking fixture pieces available and working properly on the gage?

  • C1.6 Comments regarding Calibration

D1.0 Control of Nonconforming Product

  • Check this box for an explanation of the Control of Nonconforming Product Section.

  • Since one of the goals of TS is to help ensure that Customers do not receive nonconforming product, the control system in place needs to be verified.

    This begins with raw material and components that go into product. There should be a system in place to ensure that what is released for production has been verified - whether here or at the supplier.

    If we are not to send nonconforming product to customers, then it must be identified. That is another question in this section. To bring nonconforming product back into specification, we may rework it with Customer approval. There should be instructions for doing this and there must be a re-inspection to ensure that the product is now conforming.

  • D1.1 Are controls in place to ensure only acceptable incoming material is released for production?

  • D1.2 Is nonconforming product identified and controlled to prevent its unintended use or delivery?

  • D1.3 Are rework instructions available for rework activities?

  • D1.4 Is there objective evidence of rework re-inspection for rework activities?

  • D1.5 Comments regarding Control of Nonconforming Product

E1.0 Preventive Maintenance

  • Check this box for an explanation of the Preventive Maintenance Section.

  • TS has an interest in maintenance because properly maintained equipment is required to make product that meets requirements and to ensure its manufacture in time for delivery according to Customer needs.

    This maintenance extends not just to equipment, but also tooling and production fixtures. The TS requirements touch more than is asked in this section - but these questions cover what needs to be known by the people at the work center.

  • E1.1 Is there a plan for preventive maintenance on the production tools (e.g. Die, Weld Fixture) and equipment being audited?

  • E1.1.1 Is preventive maintenance up to date for the production tools and equipment being audited?

  • E1.1.2 Is the preventive maintenance process measured for effectiveness?

  • E1.2 Are production tools identified, defining the status, such as production, repair or disposal?

  • E1.3 Are customer-owned tools identified with ownership?

  • E1.4 Comments regarding Preventive Maintenance

F1.0 Safety / Environmental / Housekeeping

  • Check this box for an explanation of the Safety / Environmental / Housekeeping Section.

  • TS requirements are rather broad in the area of safety and housekeeping. The bulk of these questions and those regarding the environment are to help ensure we are meeting our internal requirements and some regulatory ones.

  • F1.1 Is the work area unobstructed and clear of debris?

  • F1.2 Are employees wearing required personal protective equipment?

  • F1.3 Are electrical panels in the area unobstructed (36-inch requirement)?

  • F1.4 Are electrical cords, hydraulic hoses, or similar materials out of the way to prevent trip hazards?

  • F1.5 Check if there are Fire Extinguishers in the area of the Cell / Line.

  • F1.5.1 Do fire extinguishers near the cell / line indicate completed monthly inspections?

  • F1.5.2 Are fire extinguishers unblocked?

  • F1.5.3 Is the location of the fire extinguisher clearly marked and visible?

  • F1.6 Check if there are chemicals used in the Process.

  • F1.6.1 Are all containers / bottles of chemicals properly labeled?

  • F1.6.2 Is the Operator aware of all chemicals used in the area?

  • F1.6.5 List all chemicals used in the Process

  • F1.6.5.
  • .1 Chemical / Product Name:

  • .2 Is the MSDS for this chemical found using the MSDS Finder?

  • F1.6.3 Is the Operator able to state where MSDS Sheets are located?

  • F1.6.4 Does the Operator know what to do in the event of a chemical spill?

  • F1.7 Does the Operator know where to go in the event of a fire and tornado?

  • Check to reveal the Environmental Policy

  • It is the environmental policy of ArtiFlex Manufacturing, LLC to:
    • Comply with all legal, regulatory and other requirements
    • Prevent Pollution
    • Establish and review targets and objectives for the improvement and maintenance of the environment system
    • Continually improve our environment through our environmental targets and objectives.

    We have an environmental policy in order to comply with the requirements of ISO 14001, an Environmental Management System standard. We are certified to that standard to demonstrate that we are a good corporate citizen complying with all local, state, and federal regulations regarding the environment.

  • F1.8 Can the Operator convey the Environmental Policy?

  • F1.9 Does the Operator know why there is an Environmental Policy?

  • F2.0 Comments regarding Safety / Environmental / Housekeeping

G1.0 Internal Audits

  • Check this box for an explanation of the Internal Audits Section.

  • In this section, we are primarily looking for completion of the Layered Process Audits (where they are required) and the date of the last audit of this type.

  • G1.1 Check if Layered Process Audits used at this cell / line.

  • G1.1.1 Are Layered Audits completed as scheduled?

  • G1.1.2 Are nonconformities addressed to show closure?

  • G1.1.3 Are trends from nonconformities analyzed for corrective action?

  • G1.2 Date of last Manufacturing Process Audit for this Process

  • G1.3 Comments regarding Internal Audits

H1.0 Records

  • Check this box for an explanation of the Records Section.

  • In this section, we are looking first at the generation of records at the work center - completeness of information, proper inspection records, and process monitoring. The request for a signed Part Submission Warrant (PSW) must be verified in Quality by a Quality Engineer.

  • H1.1 Are sampled forms filled out correctly and completely (no blank spaces, correct date / time, etc.)?

  • H1.2 Are inspection records adequate (variable data is recorded when variable measurements are taken, legible, out-of-spec readings identified / addressed, etc.)?

  • H1.3 Are feedback / informational / production boards filled out and up to date?

  • H1.4 Is there a signed Part Submission Warrant on file for the part currently running?

  • H1.5 Comments regarding Records

I1.0 Corrective and Preventive Action

  • Check this box for an explanation of the Corrective and Preventive Action Section.

  • This section is looking to ensure that people at the work center are aware of any corrective action activities associated with their production = whether a formal 8D, Quality Alert, or even Temporary Work Instructions.

    Then there are questions relative to corrective action, in general. These probably cannot be answered at the work center. These would be seen in the CAR System in Quality.

  • I1.1 Check if any Corrective Actions / Quality Alerts / Temporary Memos apply to the line / cell.

  • I1.2 Is the team aware of them?

  • I1.3 Is the team aware of the requirements listed in them?

  • I1.1 List all that apply:

  • I1.2 Are quality alerts posted and removed when expired?

  • I1.3 Are negative trends in the manufacturing process (Walkabout, Layered Audit, etc.) addressed?

  • I1.4 Are action items assigned and communicated to the appropriate people?

  • I1.5 Are action items completed in a timely manner?

  • I1.6 Are actions applied to similar parts / processes?

  • I1.7 Comments regarding Corrective / Preventive Action

J1.0 Continual Improvement

  • Check this box for an explanation of the Continual Improvement Section.

  • TS requires that processes are improved. These can be the Manufacturing Process being audited, the Receiving Process, the process for handling accounts payable - whatever. These few questions deal with some of those.

  • J1.1 Are employees aware of the quality objectives that they impact (I.e., operational efficiency, delivery performance, etc.)?

  • J1.2 Is there a process in place for employees to communicate their continual improvement ideas?

  • J1.3 Continual Improvement tools. Check each that apply:

  • J1.3.1 Walkabout Process

  • J1.3.2 Layered Process Audit

  • J1.3.3 Other (could be plant-specific, supervisor initiative, etc.)

  • Other Process Name

  • J1.4 Comments regarding Continual Improvement

K1.0 Training

  • Check this box for an explanation of the Training Section.

  • This section of the audit is merely data collection. Like the recording of documents and gages, record the names and clock numbers of people encountered in the audit for later verification of the records with Human Resources.

  • K1.1 List all personnel at the cell / line for verification

  • K1.1.
  • Name

  • Clock Number

  • Is the operator trained to the appropriate level?

  • Do employee competency evaluation records show that employees are competent to perform the work they are observed performing?

  • K1.2 Comments regarding Training

L1.0 Audit Commentary

  • L1.1 Comments:

M1.0 Review

  • M1.1 Auditor

  • M1.2 Supervisor / Plant Manager

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