Restricted Shipping Level I
 

Description: Restricted Shipping Level I is a requirement by Dana that a supplier put in place  an additional 100% containment process at the supplying location to contain for specific and or specified nonconformances.  The Supplier Must implement a root-cause problem solving process, and isolate Dana from the receipt of nonconforming parts/material.  The additional 100% containment is in addition to all normal controls.  It is enacted by the supplier’s employees, and must be in addition to the normal production process controls.

Additional Description: The data obtained from the additional 100% containment process is critical as both a measure of the effectiveness of the primary containment process and the corrective actions taken to eliminate the initial nonconformance.

Criteria for Application (any of the items below may be considered):

• All nonconformance

• Supplier’s current controls are not sufficient to ensure conformance to requirements

Deliverables:

• Certified Material to the Dana facility

• Problem Resolution Workbook to demonstrate  effective root cause analysis and effective containment  (nonconforming vs. quantity checked)

• Documented and verified Corrective Action

• Additional process controls (poka-yoke) to prevent future occurrences

• Revised Process Flows, PCPs, PFMEA, Standardized work instructions as required

• Restricted Shipping Level I Entry letter

• Restricted Shipping Confirmation Reply Form

• Completion of all requirements within the Dana SCAR system

• Restricted Shipping Level I Exit Letter

Resources: Dana Facility Quality/Reliability Department, Dana Supplier Quality Engineer, Buyer, and supplier

Methodology:

Assessment Phase

-         Dana Manufacturing/Assembly Plants or SQE initiate Restricted Level I, referencing the nonconformances or observations that the Supplier’s current controls are not sufficient to ensure conformance to requirements.

Entry/ Implementation Phase

• Initiator notifies the supplier (staff level) they are being placed in Restricted Shipping Level I

.• Initiator sends formal confirmation to the supplier via a Restricted Shipping Level I Entry letter, addressed to the supplier’s Top Management.

• Initiator contacts the supplier (via conference call or meeting) to:

-         Review the non-conformance that resulted in the Level I entry.

-         Review and approve the supplier’s containment process which includes:

o       Data collection utilizing an I-chart.

o       Communication back to Dana (including frequency).

o       Control of non-conforming product.

-         Review and approve the supplier’s escalation/reaction plan for the containment activity.

-         Establish boundary samples and/or specifications for acceptance/rejection of the parts.

-         Establish exit criteria for the Level I. Default criteria as follows:

o       30 working days of data (from the date of implementation of permanent corrective action) which verifies that the normal production controls are effective for controlling the discrepancies identified in the Restricted Shipping activity.

o       Documentation showing the root cause was identified and verified.

o       Documentation indicating the level of error proofing implemented.

o       Copies of all documentation revised as required (Control plan, FMEA’s, Process Flow, operator instructions, etc.)

o       Documentation indicating that every effort was taken to implement error proofing.

• Initiator requests the support of the Dana Supplier Development if the supplier is uncooperative in implementing Level to our requirements.

• Supplier does the following:

-         Ensure understanding of the nonconformance.

-         Return confirmation letter as required.

-         Develop an escalation/action plan.

-         Immediately establish a separate containment activity area at their location that is acceptable to Dana.

-         Notify additional Dana Plants that use the same part, inform them of the nonconformance, and provide containment activities as necessary.

-         Track breakpoints of nonconforming material. (Purge pipeline of suspect material, i.e. at Dana’s facility, in transit and at all storage locations.)

-         Mark individual parts, material, and containers, as agreed upon by Dana, to identify parts certified for production.

-         Provide proper layout and instruction documents, space and tooling to perform Restricted Shipping - Level I.

-         Commence the containment activities and display the results in a public and visible location.

• Supplier Development does the following:

-         If requested, intervene to support the initiator if the supplier is uncooperative in implementing Level I per Dana’s requirements.

-         Notify Purchasing Manager if commercial intervention is required.

Monitor and Check Phase

• Supplier does the following:

-         Perform an additional 100% containment of all suspect non-conforming products per the agreed upon process and ensure defect free parts/material are delivered to Dana.

-         Process in a timely manner the corrective actions requested by Dana.

-         Update all applicable documentation, (i.e. Process Control Plan, PFMEA, Flow Diagram, and Standardized work Instructions etc).

-         Document containment data in I-chart format.

• Initiator does the following:

-         Monitor supplier’s containment data (I-chart.)

-         Verify the supplier root cause and corrective action.

-         Verify the supplier updated all applicable documented documentation (i.e. Process Control Plan, PFMEA, Flow Diagram, and Standardized work Instructions etc).

Verification for Exit

• Supplier does the following:

-         Meet the defined exit criteria.

-         Requests exit from Restricted Shipping Level I and provide supporting documentation and assessments on performance and corrective actions to the appropriate Dana representative.

• Initiator does the following:

-         Verify that the supplier has met all exit criteria. The Supplier is removed from Level I after all exit criteria are met and the established time has expired without further nonconformances at the Dana Assembly /Manufacturing Facility, or coming out of the Supplier’s process.

-         Notify the supplier verbally that they have met the criteria and that they will be removed from Level 1 upon receipt of the Level 1 exit letter.

-         Issue a Restricted Shipping Level 1 Exit letter to the supplier for official notification that they have met the exit criteria.

Initiator Responsibility:

-         Confirm supplier’s non-conformance and reviews their quality performance.

-         Verbally notify the supplier’s management of the non-conformance and entry into Level 1.

-         Communicate Level 1 requirements to the supplier (including exit criteria.) via conference call or meeting.

-         Complete appropriate documentation for formal notification to the supplier.

-         Verify and approve supplier’s Restricted Shipping plan/process.

-         Monitor supplier’s containment data (I-chart).

-         Verify supplier’s root cause analysis and corrective actions.

-         Verify the supplier’s process control improvements and validation plan/frequency.

-         Verbally notify the supplier’s management of their removal from Level 1.

-         Complete appropriate documentation for formal notification of removal from Level 1.

Supplier Development Responsibility:

-         • If requested, intervene to support the initiator if the supplier is uncooperative in implementing Level 1 per Dana’s requirements.

-         Notify Commodity Manager if intervention is required.

Supplier Responsibility:

-         Ensure understanding of the nonconformance.

-         Return confirmation letter as required.

-         Develop an escalation / action plan.

-         Implement a Level I containment activity to ensure defect free parts/material are properly identified and delivered to Dana.

-         Notify additional Dana Plants that use the same part and inform them of the nonconformance.

-         Purge pipeline of suspect material.

-         Determine root cause.

-         Develop, implement, and validate permanent corrective actions and process controls.

-         Update all applicable documents.

-         Document containment data in I-chart format.

-         Communicate action plans, containment status, and results of problem resolution activities to Dana in a format and with a frequency agreed to by the Dana representative.

-         Meet the defined exit criteria.

-         Request exit from Restricted Shipping - Level I with appropriate supporting documentation.

Restricted Shipping Level II

Description: Restricted Shipping Level II)(Description:) Restricted Shipping Level II is a Dana requirement of a supplier to put in place a certified 3rd party  containment process to contain for a specific nonconformance, while implementing a root cause and corrective action problem solving process. (Root Cause and Corrective Action must be verified by 3^rd Party Quality Engineering)The additional containment is over and above the normal controls as well as Restricted Shipping Level 1 containment activities.

Additional Description: The 3rd party or a Dana representative will perform assessment audits. The data obtained from the 3rd party additional containment process as well as the audits are critical as both a measure of the effectiveness of the secondary containment process and the corrective actions taken to eliminate the initial nonconformance.

Criteria for Application (any of the items below may be considered):

-         Repeat CAR, SCAR, DMR,& NCMR's

-         Duration, quantity, and/or severity of the problem

-         Restricted Shipping Level I failures

-         Major Disruptions

-         Quality Problem (i.e. Pass through defects, Customer complaints, Warranty, etc..)

Deliverables:

-         Certified Material to Assembly Plant

-         I-Chart to demonstrate product quality (nonconforming vs. quantity checked by a 3rd party)

-         Documented and verified corrective action

-         Revised PCP’s, PMEA, Operator Instructions as required

-         Restricted Shipping Level II Entry Letter

-         Restricted Shipping Confirmation Reply Form

-         Restricted Shipping Level II Exit Letter
 

Resources: Dana Plant Quality/Reliability Department, Dana Supplier Quality Engineer, Buyer, supplier, and 3rd Party Provider

Methodology:

Assessment Phase:

-         Dana Manufacturing/Assembly Plants or SQE initiates Restricted Shipping Level II, referencing the non-conformance observations at the supplier, the supplier’s internal /external data, or other criteria for application.

-         Re-implementation of Restricted Shipping Level II due to a repeat nonconformance that requires 3rd Party Register notification, the initiator will obtain the concurrence of the Dana Supplier Development Group prior to notifying 3rd Party Register.

Entry/Implementation Phase:

• The initiator verbally notifies the supplier that:

-         They are being placed on Restricted Shipping Level II.

-         Containment must be initiated immediately, in order to protect Dana.

-         Entry letter will follow.

-         Supplier must contract an authorized 3rd party Level II Provider.

-         Initiator will be holding a kickoff meeting/conference call.

• Initiator/SQE sends formal confirmation to the supplier via a Restricted Shipping Level II Entry letter, addressed to the supplier’s Top Management.

• Initiator/SQE and the Supplier agree on 3rd party provider.

• Supplier contacts a Restricted Shipping 3rd party and issues a purchase order for Restricted Shipping Level II activities within 24 hours of receiving the Level II letter.

• Supplier returns confirmation letter.

• Initiator/SQE and 3rd party provider hold a kickoff meeting or conference call with the Supplier’s Quality Manager and Plant Manager to:

-         Review the non-conformance that resulted in the Level II entry.

-         Review and approve the supplier’s containment process which includes:

o       Data collection utilizing an I-chart

o       Communication back to Dana (including frequency)

o       Control of non-conforming product

-         Review 3rd party provider actions/assessments as required.

-         Review and approve the supplier’s escalation/reaction plan for the containment activity.

-         Establish boundary samples and/or specifications for acceptance/rejection of the parts.

-         Establish exit criteria for Level II.

• Supplier performs an additional containment of all suspect nonconforming products per the agreed upon process to ensure defect free parts (Level I).

• Supplier notifies additional Dana Plants that use the same part, informs them of the nonconformance, and provides containment activities as necessary.

• The 3rd Party Provider performs a 2^nd additional containment of all suspect non-conforming products per the agreed upon process to ensure defect free parts are delivered to Dana.

• 3rd party Provider Quality Engineer and the Dana SQE reviews the Supplier’s process and quality history.  The 3^rd party Provider completes the Assessment.

• Initiator/SQE requests the support of the Dana buyer if the supplier is uncooperative in implementing Level II and or supplying a PO number for 3rd party provider to Dana’s requirements.

• Supplier submits irreversible corrective action plans to the                       ISO 9001:2000/TS16949 registrar for review and/or assessment and authorizes ISO 9001:2000/TS16949 registrar to submit the review and/or assessment findings to Dana.

• Buyer does the following:

-         If requested, intervene to support the SQE if the supplier is uncooperative in implementing Level II and/or supplying a P/O# for 3rd party provider per Dana’s requirements.

-         Notify Commodity Manager if intervention is required.

Monitor and Check Phase:

• Supplier does the following:

-         Perform an additional containment of all suspect non-conforming products per the agreed upon process and ensure defect free parts/material are delivered to Dana. (Restricted Shipping Level I Requirements)

-         Contracts a 3rd Party Provider, acceptable to Dana Limited, who performs an additional containment process of all suspect non-conforming products per the agreed upon process to ensure defect free parts are delivered to Dana. The supplier is responsible for all costs of the Controlled Shipping third party for the activity.

-         Determine and demonstrate the root cause to Dana Initiator/SQE

-         Develop, implement and validate the permanent corrective actions, along with improved process controls (i.e., error proofing, layered audits, setup checklists, standardized work, operator training and certification program, etc.)

-         Document containment data in I-chart format.

-         Implement lessons learned.

-         Update all applicable documentation, (i.e. Process Control Plan, PFMEA, Flow Diagram, and Standardized work Instructions etc.)

-         Communicate the action plan, containment status, and results of problem resolution activities to Dana in a format and with a frequency agreed to by the Dana representative.

• Initiator does the following:

-         Monitor supplier’s containment data (I-chart).

-         Verify the supplier has a documented process control validation program in place (such as job setups, setup error proofing, process error proofing, layered auditing, operator training & certification etc.)

-         Verify supplier’s root cause analysis and corrective actions.

Verification for Exit:

• Supplier does the following:

-         Meet the defined exit criteria.

       Obtains 3^rd Party Validation of proposed corrective action

-         Requests exit from Restricted Shipping - Level II and provide supporting documentation and assessments on performance and corrective actions to the appropriate Dana representative. (Dana plant representative will be notified if required.)

• Initiator does the following:

-         Verify that the supplier has met all exit criteria. (May be performed by the 3rd party.) The Supplier is removed from Level II after all exit criteria are met and the established time has expired without further non-conformances at the Dana Assembly /Manufacturing Plant or coming out of the Supplier’s process.

-         Notify the supplier verbally that they have met the criteria and that they will be removed from Level II upon receipt of the Level II exit letter.

-         Issue a Level II exit letter to the supplier for official notification that they have met the exit criteria.

Initiator Responsibility:

• Confirm supplier’s non-conformance and review their quality performance.

• Verbally notify the supplier’s management of the non-conformance and entry into Level II.

• Verify and approve supplier’s 3rd party provider selection.

• Hold kickoff meeting with 3rd party provider and supplier as specified in the Entry/Implementation phase.

• Complete appropriate documentation for formal notification to the supplier.

• Verify and approve supplier’s Restricted Shipping plan/process.

• Monitor supplier’s containment data (I-chart).

• Verify supplier’s root cause analysis and corrective actions.

• Verify the supplier’s process control improvements and validation plan/frequency.

• Verbally notify the supplier’s management of their removal from Level II.

• Complete and distribute the appropriate documentation for formal notification of removal from Level II.

Supplier Responsibility

• Ensure understanding of the nonconformance.

• Develop an escalation / action plan.

• Contact and issue a purchase order to the Restricted Shipping 3rd party for Controlled Shipping

-         Level II activities. The supplier is responsible for all costs of the Controlled Shipping third party for the activity.

• Return confirmation letter.

• Implement a Level II containment activity to ensure defect free parts/material are properly identified and delivered to Dana.

• Purge pipeline of suspect material.

• Notify additional Dana Plants that use the same part and inform them of the nonconformance.

• Submits irreversible corrective action plans to the ISO 9001:2000/TS16949 registrar for review and/or assessment and authorizes ISO 9001:2000/TS16949 registrar to submit the review and/or assessment findings to Dana.

• Authorize ISO 9001:2000/TS16949 registrar to submit the review and/or assessment findings to the Dana.

• Determine root cause.

• Develop, implement, and validate permanent corrective actions and process controls.

• Update all applicable documents.

• Document containment data in I-chart format.

• Communicate action plans, containment status, and results of problem resolution activities to Dana in a format and with a frequency agreed to by the Dana representative.

• Satisfy all additional requests noted on the Level II Entry Letter and/or communicated during the Kick off meeting.

• Meet the defined exit criteria.

• Request exit from Restricted Shipping - Level II with appropriate supporting documentation.

Buyer Responsibility:

• Intervene to support the Initiator/SQE if the supplier is uncooperative in implementing Level II per Dana’s requirements.

• Notify Commodity Manager if intervention is required.

3rd Party Responsibility:

• Participate/Lead the Level II Kick off meeting.

• Supply the required/agreed upon resources to perform the Level II activity.

• Perform Level II activity as contracted.

• Set up and verify conformance for all Level II activity.

• Supply containment results (I-chart) as required/requested.

• Verification that the Supplier’s Root Cause, Corrective Actions, Process Controls, Process Documentation is updated and complete. (Verify adequate completion of the problem resolution workbook

• Supply required documentation to the Dana Initiator/SQE to meet the Level II requirements (as applicable).

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