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Certification Process


A Certified Supplier is a supplier that meets the preferred status rating and has demonstrated over time the capability of meeting all process and product quality requirements.

This section describes the two phases of the certification process: (1) pre-certification and (2) post-ongoing certification. All suppliers that have previously complied with the qualification requirements in Supplier Qualification procedures are required to participate in this process. This section also applies to distributors.

Pre-certification Phase

Before a purchased part becomes certified, a series of important activities must be jointly conducted to establish the objective evidence of manufacturing process control, conformance to product specifications, and on time delivery.

The supplier, together with Electro Scientific Industries Purchasing, Program Manager/Engineering and Supplier Quality Engineer, will arrange the pre-certification phase activities after successful completion of the qualification assessment, whether during the same visit or by scheduled follow-up. Previously qualified suppliers will be contacted by telephone or by mail.

When applicable, these activities can also be arranged during the joint manufacturing and quality review session, see Quality System. In any event, the supplier will be notified.     Top

Essential Steps for Quality System Certification

Decide which processes/products to certify.


Establish process/ product control plans (part inspection plans).

These plans should contain the following:

  1. Key/ critical characteristics and target values.
  2. Measurement method for each key/critical characteristics.
  3. Inspection instructions for key/critical characteristics.
  4. Measurement frequency.
  5. Sample size.
  6. Work cell quality data collection.
  7. Resource requirements and capabilities.
  8. Reaction plans for out-of-control conditions.

Establish manufacturing control plans.

These plans should include the following:

  1. Machine set-up procedures.
  2. Production operation or method sheets.
  3. Preventive maintenance schedules and plans.
  4. First production tooling approval.
  5. Pre-control charts.

Perform formal problem-solving techniques.

  1. Evaluation of work cell yields.
  2. Design of experiments.
  3. Seven QC tools (Flowcharts, Scatter Diagrams, Histograms, Pareto Charts, Cause-and-Effect Diagrams, Check Sheets, Control Charts).
  4. Seven Management Tools (Affinity Diagram, Relation Diagram, Tree Diagram, PDPC Charts, Arrow Diagram, Matrix Diagram, Matrix Data Analysis).

Perform statistical validation.

Establish statistical process control:
  1. Variable data is preferred (X-bar, R charts).
  2. Identify key /critical characteristics.
  3. Identify processes and product characteristics that are continually out of specification.
  4. Identify processes and product characteristics that have the most variation associated with them.
  5. Establish preventive corrective action matrices.

Determine process capabilities.
  1. Each work cell should be greater than 95% yield.
  2. Ongoing inspection yield less than 0.5% defects.

Apply ongoing continuous improvement.

  1. Training.
  2. Statistical tools and problem solving techniques.
  3. Defect prevention and variation reduction.
  4. Implementation of new technologies.
  5. Cross-functional training of team members.
  6. Develop training manuals or guidelines.
  7. Establish a timing chart for implementation of training.     Top

Overview: Pre-certification Phase Activities


Step 1: Joint review of requirements. This includes agreement on communication flow, and review of current product specifications, classification of characteristics (including variables, finish standards, and certified finish samples), and briefing of performance rating system and certification process.

When applicable, supplier performance history (e.g., non-conformance reports, response to corrective action and late deliveries) are reviewed for identification of unresolved part problems. The presence of part problems may postpone pre-certification activities until resolved. Otherwise, proceed to step 2.

Step 2: Pre-certification review period. Pre-certification review is conducted and monitored by Electro Scientific Industries SQE. Duration of the review period is a select number of consecutively produced, conforming, and on-time units or lots based on criticality of product application and anticipated volume.

Note: Waiver of the pre-certification review period may only be justified by objective evidence from Electro Scientific Industries defect data exhibiting the following: 100% conformance to the Product/Process Control Plan or existing Part Inspection Plan parameters of consecutive incoming lots to date in accordance with the above review period duration schedule.

Step 3: Product/Process Control Plan and/or Part Inspection Plan. The Product/Process Control Plan and/or the Part Inspection Plan establish a virtually identical inspection scheme between the supplier and the Electro Scientific Industries during the pre-certification review period. The plan will designate the "critical" quality characteristics as a minimum, supersede all other previous plans, and establish the supplier's inspection parameters for maintaining ongoing certification. If Electro Scientific Industries does not identify the "critical characteristics" it shall be the responsibility of the supplier to identify them. These characteristics are ones, which reasonably anticipate where variations could significantly affect the products form, fit or function. The supplier shall implement this plan into its manufacturing operations and quality system. Proposed changes must undergo review and approval by both the supplier and the Electro Scientific Industries SQE and Program Manager.

The Product/Process Control Plan and/or Part Inspection Plan represent the agreement between both parties. This agreement indicates the start of the pre-certification review period; however, it does not constitute part certification approval. It also indicates the supplier has been formally briefed of the entire certification process and acknowledges responsibilities of the same. Proceed to step 4.

Step 4: Ongoing Certification Activities/Certification Maintenance. In the Ongoing Phase emphasis is placed on continuing the output of excellent quality after the supplier and product are certified.

Major areas of concern:
  • Maintain and continually improve equipment capability.
  • Maintain and continually improve process capability.
  • Effective statistical process controls must be in place and maintained.
  • Effective internal audit system of the systems, processes and products.
  • Continual communication program with the customer and the supplier of key/critical activities and characteristics.
The supplier must now understand that product conformance and timely delivery is much more vital than ever before. In the ship-to-stock certified mode, incoming material is no longer handled until it arrives at the Electro Scientific Industries production lines. These lines depend heavily on material conformance to specifications and the timeliness of delivery to maintain flow, minimize costs, and meet customer order demands. The additional lead-time that was once accessible for the incoming inspection, disposition, and turnaround of purchased material is no longer available.

Note: Non-conformance occurring within the review period warrant immediate corrective action and a written response through a Continuous Improvement Plan. A complete re-start or extension of the originally specified review period may be requested. Repeated incidents may warrant supplier disqualification. To maintain Preferred Supplier status and to continue with the certification process, the supplier must not drop below the required rating scores in all categories, refer to Supplier Performance Rating System.     Top

Ongoing Part Certification Requirements

The requirements for the ongoing part certification phase are:

  1. Applicable part certification documentation shall be maintained in part files by both the Supplier and Electro Scientific Industries.
  2. The supplier will ensure documented inspection and test results (real time SPC data preferred) corresponding to Product/Process Control Plan or the Part Inspection Plan parameters are traceable to certified part production runs and continue to accompany every shipment to Electro Scientific Industries, when requested by the Electro Scientific Industries SQE, for a period of one year after part certification approval.
  3. Unless otherwise specified, the supplier shall perform product quality assessments on certified parts at least annually, beginning no later than one year after part certification approval, and shall submit the assessment results to Electro Scientific Industries SQE. Assessment inspection parameters shall be the same parameters as established by the Product/Process Control Plan or Part Inspection Plan for the pre-certification phase, including the same sampling scheme. Results are to be filed and available for future reference.
  4. Electro Scientific Industries shall conduct periodic part assessments on incoming production shipments. Assessment parameters shall be, but are not limited to, the same parameters as established by the Product/Process Control Plan or Part Inspection Plan.
  5. Part certification steps are:
    • Parts to be certified must be from a Preferred Supplier.
    • Supplier Quality Engineer will maintain a list of Preferred Suppliers and make it available to interested parties.
    • Electro Scientific Industries completes a Product/Process Control Plan, Part Inspection Plan or equivalent.
    • Product/Process Control Plan or Part Inspection Plan has been sent to the supplier by the Electro Scientific Industries SQE.
    • The Supplier and Electro Scientific Industries SQE agree on the requirements listed on the Product/Process Control Plan or Part Inspection Plan.
  6. Submit Gage Repeatability and Reproducibility for critical characteristics [GR&R10%].
    Submit Process Capability Study for critical processes. Submit process map for each process.
  7. Parts may be certified after a minimum of three consecutive lots are received from the Supplier without any rejects.
  8. Supplier Quality Engineer sends a letter to the Supplier advising them that the specific part has met the Part Certification Requirements.     Top

Supplier Performance

The supplier performance rating system defined in the Performance Rating section of this standard applies indefinitely to all certified parts. After successful participation in the ongoing part certification phase for a period of one year, the supplier is placed on "certified status" for the subject part. Conversely, the supplier is cautioned to understand that failure to meet or exceed minimum performance ratings on certified shipments will warrant a probationary period and possible supplier disqualification of the subject part.   Top