Supplier Audit Checklist

Supplier Name:

1.0 Customer Satisfaction

1.1 Customer Satisfaction Survey

c

c

ni

Comments

1.2 Customer Service (Field Returns & Responsiveness)

C

c

ni

Comments

1.3 Cost Reduction Efforts

c

ni

ni

Comments

1.4 Delivery Performance (Stock Out, Turns, JIT)

C

C

ni

Comments

1.5 Customer Owned Tooling

c

c

ni

Comments

2.0 Quality System

2.1 Internal Quality Audit

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C

c

Comments

2.2 Quality Goals and Improvement Plan

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ni

ni

c

Comments

2.3 Corrective and preventive action system

c

c

ni

Comments

2.4 Operator Qualifications / Training

C

C

ni

Comments

2.5 Environmental, Health and Safety (EHS)

c

ni

ni

Comments

3.0 Manufacturing process3.1 Work Instructions

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c

c

Comments

3.2 Work in Process

C

c

ni

Comments

3.3 Outgoing Quality Audit

C

ni

C

Comments

3.4 Product/Process Change Control

c

c

c

Comments

3.5 Material Traceability

C

C

C

Comments

3.6 Preventive Maintenance Actions

c

C

C

Comments

3.7 Measurement Systems

c

ni

ni

Comments

3.8 Process Control Plans

C

C

ni

ni

Comments

3.9 Statistical Process Controls

c

c

ni

Comments

3.10 Process Capability Cpk

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ni

ni

Comments

3.11 FMEA (design stage and manufacturing process)

C

C

ni

Comments

3.12 Advanced statistical tools (Design of experiments, Taguchi experiments)

ni

ni

ni

Comments

4.0 Material Management

4.1 Incoming Inspection (Purchased material conformance to requirements)

c

ni

ni

Comments

4.2 Purchasing Process (Product requirements communicated to subcontractor)

c

c

na

Comments

4.3 Subcontractors Performance

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nc

na

Comments

4.4 Subcontractors selection/evaluation

na

c

na

Comments

4.5 Control of nonconforming material

c

c

ni

Comments

4.6 Material handling control

c

ni

ni

Comments

4.7 Customer Packaging/Bar-coding / Labeling Standards

na

c

c

Comments

Supplier Audit Checklist

Supplier Name:

Customer Satisfaction

Customer Satisfaction Survey

Customer Service (Field Returns & Responsiveness)

Cost Reduction Efforts

At least one year of cost reduction data is available to support these efforts.

Delivery Performance (Stock Out, Turns, JIT)

A customer satisfaction measurement system (survey) is established.

Survey results are documented and trends of key indicators are available for reference.

Management reviews results and takes corrective actions. Effectiveness is proven by positive customer feedback.

A system defined to timely respond to customer complains and reduce cycle time of RMA, SCAR, RFQ.

Customer returns are systematically tracked, evaluated and corrective actions implemented.

Supplier has an assigned representation.

The contact matrix is available for reference.

Field return rate is measured, shows improvement and corrective actions are effective.

Supplier has a cost reduction procedure that describes areas affected and methods to be employed. The system is strongly supported by management.

Supplier systematically pursues cost reduction opportunities in all areas and data shows improvement for the past year. Cost reduction goal is defined.

Procedure in place to expedite customer requirements and keep customer commitment. Supplier is flexible in fulfilling urgent requirements and address abnormal situations.

Supplier delivery charts and reports are available.

Schedules for production and shipping are well communicated and executed.

Supplier systematic reviews schedule sharing and monitors stock outs and turns.

Customer Owned Tooling

Preventive maintenance system used to maintain tools with schedule available and adhered to.

Quality System

Internal Quality Audit

Audits are routinely scheduled and deployed as per procedure.

Quality Goals and Improvement Plan

The entire organization is trained in the principles of 6 Sigma for problem prevention, problem solving and process mapping.

Quality goals are communicated to personnel.

On time delivery performance is monitored, and corrective actions are taken.

Delivery charts and reports show performance improvement.

Customer owned data is easily identified, readily retrievable and stored in a clean environment.

Tool usage ( number of parts molded), expected lifetime and tool changes are documented.

Tool replacement plan in place. Preventive tool maintenance program.

Internal quality audit procedure is established.

The auditors are qualified and free of potential conflict of interest.

Audit reports are recorded and communicated to the team. (Schedules and reports are available).

Management reviews audit results and support corrective actions (meeting minutes).

Corrective actions are timely implemented and proven effective (no recurrences).

The effectiveness of corrective actions is documented in follow-up audit activities.

Quality goals are measurable and clearly identified by management (I.e. 6 Sigma quality, just in time delivery, zero field returns, 10X-5 year (37% reduction per year) cycle time improvement, internal audit program).

Management systematically reviews the quality metrics, goals, field returns and the action plan.

The improvement plan drives the entire operation to the quality goals.

Corrective and preventive action system

Robust retrieval system for corrective action reports.

Permanent corrective actions are implemented and verified during audit follow-up.

Consistent management support for permanent corrective actions implementation.

Focus on prevention (systemic approach) versus fire fighting (containment actions approach).

Operator Qualifications / Training

It captures proper operation of the instruments, tools, understanding documentation.

Training plans are available across the shifts and training records retained as quality records.

Environmental, Health and Safety (EHS)

The organization has a written EHS program.

Employees are aware of chemical hazards associated with the work environment. Records are available to prove program implementation.

Records of reviews and performance trends are available.

Evidence of continuous improvement and effective quality system is available.

A structured corrective action process i.e.8d is defined and to be used for all customer complains and all areas of the business.

A cross functional team involved in the corrective action process. Training is available at all organization levels. Prompt containment action are taken in order to protect the customer, until the corrective actions are implemented. Problem solving techniques are utilize to determine the correct root cause.

Prompt containment action are taken in order to protect the customer, until the corrective actions are implemented.

Problem solving techniques are utilize to determine the correct root cause.

System effectiveness proven through no recurrences at customer site and reduction of problems.

There is a documented procedure that identifies training needs, training records, qualifications and certifications required.

Continuous on the job training is provided in order to ensure consistency in performing the task.

Training effectiveness is evaluated and personnel qualifications are tested. Employee evaluations of performance are conducted.

Manufacturing processWork Instructions

Operating Process Instructions are developed for all process.

Latest revision is accessible to operating personnel in all cases. Old revisions are obsolete and identified as such.

Appearance items master standards and pedros are available for plastics cosmetical aspects.

Work in Process

Process flows are established.

WIP is defined with established Kanban at each major station.

Outgoing Quality Audit

Outgoing quality procedure is established as per customer requirements.

Clear definition of authority to release product. Appropriate quality records are available.

The acceptance criteria is zero defects in all cases. Any other situations require customer waiver.

Rejected material is quarantined, the rejection condition is evaluated and corrective actions taken.

Product/Process Change Control

Procedure for product/process changes in place.

New changes are communicated through training to all personnel. Procedures, documents are updated, old revisions are obsolete.

Proposed changes are piloted and verified. Implementation records are available.

Proactively informs customer prior of change and seeks confirmation and written approval before change is made.

There are records indicating improvements trends regarding the safety incidents.( ie , Machinery, proper guard rails, aisle ways, ventilation, etc )

The manufacturing operation is performing with no WIP. Operation time is balanced between stations and supplier is considered industry benchmark.

Material Traceability

Establish and implement a procedure for product identification during all stages from receiving through shipping.

Traveler traceable to each process based on date code or some other tracking system.

System check proves effectiveness.

Preventive Maintenance Actions

PM procedure is established and defines activities.

The PM schedule, replacement parts, list of equipment and records of the PM procedure implementation are available.

Procedure is consistently followed. Equipment down time eliminated or improvement shown.

Measurement Systems

Right testing equipment in place.

A calibration procedure with schedule, inventory, and recall system is established.

GR&R methodology is defined.

Personnel has a clear understanding of the measurement equipment usage, GR&R methodology, calibration.

GR&R methodology is implemented and include reproducibility, repeatability and comparison to process variation.

Improvement shown on the measurement systems ( GR&R errors, calibration performance).

Process Control Plans

Processes are mapped and opportunities for error identified.

Effective implementation of the process control plans in a consistent manner across manufacturing.

All instruments, including new acquired or relocated ones, have a calibration sticker that contains calibration date, who performed it and expiration date.

Measurement error greater than 30% is unacceptable , between 10~30% is marginally acceptable for non critical applications, and less than 10% is acceptable for critical measurement.

Control plans are evident for all processes and contain following elements: process, equipment, critical characteristic, measurement method, sample size, frequency and analysis method.

Continuous update based on process changes .

Statistical Process Controls

Well defined SPC system focused on elimination of special causes and achievement of process stability.

SPC data is collected and used to control processes.

Key processes and critical characteristics are properly identified based on customer spec or DOE.

Out of control situations are well defined and reactive plan taken in order to eliminate recurrence.

Continuous update of control limits based on process modifications.

Process Capability Cpk

Process capabilities studies are defined for critical processes as per process control plan.

All critical processes are stable (In control) and capable ( cp>2; cpk.>1.5).

Greater sample size used as containment action until Cpk is met and the process proved capable.Corrective actions are taken when process is not stable or not capable.

Evidence of continuous improvement on critical characteristics.

No examples of customer complains traced to incapable processes.

FMEA (design stage and manufacturing process)

FMEA or equivalent predictive prefailure analytical techniques I.e. fault tree analyses are used to define critical characteristics.

FMEA records are available to prove implementation. A cross functional team is part of the FMEA development.

Corrective actions are driven and defect trends eliminated.

Advanced statistical tools (Design of experiments, Taguchi experiments)

The organization defines the need of DOE as an integral part of new product/processes development.

Extensive training program in place. Supplier has records of DOE techniques used in the products/processes developmental stages.

Examples to demonstrate effectiveness of advanced statistical tools used toward more robust products.

Material Management

Incoming Inspection (Purchased material conformance to requirements)

Purchasing Process (Product requirements communicated to subcontractor)

Subcontractors Performance

Subcontractors selection/evaluation

There is a documented policy to assure conformance to requirements for purchased products prior to use ( incoming inspection, part qualification requirements or other methods).

Purchased material waiver procedure documented.

All purchased material compliance or noncompliance activities are documented with records available.

Dock-to-stock activities employed based on proove of received material quality level improvement.

Exceptions to the purchased material requirements I.e. waivers, "use-as-is" are rare and compliant to the policy.

A system in place to ensure purchasing documents clearly describe the product or service being ordered and inform subcontractors of revisions to PO's or specifications.

Evidence of purchasing documents clearly describing the product or service being ordered.

Print acceptance forms or equivalent are available in all cases where specifications or new revisions are provided.

Purchased material is qualified as per supplier requirements. Defined requirements are correlated to the organization design, manufacturing and end product needs.

A formal rating system was defined for the subcontractors and takes into consideration quality, on time delivery, purchased price (customer specified subcontractors are included).

Subcontractor performance ratings are available.

Nonconforming purchased material data is tracked and data feed back to subcontractors.

Improvement is shown in subcontractors performance.

A formal system for subcontractors selection/ evaluation in place.

A list of approved / preferred suppliers is maintained and reviewed as per procedure.

On-site supplier audits are conducted, supplier quality and business reviews occur.

Follow-up activities are conducted and improvement is shown in subcontractors performance.

Control of nonconforming material

Rework and repair activities are documented.

The action plan for reducing nonconformity rate is implemented and progress is tracked.

Material handling control

There is a procedure for material control.

Full inventory control, storage, ESD, material handling, shelf life, storage conditions is in progress.

Material is easily recognizable as of its status, and next operation destination.

Traceability for material is in place and proven effective.

Customer Packaging/Bar-coding / Labeling Standards

Evidence of bar code label of outgoing product to client is provided to show adherence to the UT bar-code requirement.

Systemic approach for disposition of nonconforming material through rework, repair, scrap, accept as is, customer waiver.

Nonconforming material is identified as such, physically segregated, and regularly evaluated. .

A procedure, compatible to clients bar code requirements exists.

Client incoming inspection has no records of bar code incidents from supplier.