Title: Supplier Declarable Substances Compliance Documentation Requirements

Transcription

1 Document Level: II Process Owner: Product Assurance Title: Supplier Declarable Substances Compliance Documentation Requirements Document Number: Revision: E Page: 1 of 8 Approved By: Bill Pratt Ron Fry John Herniman Larry Graham VP, Global Services Sr. Dir, Procurement VP, Corporate Quality ISO Program Manager Referenced Forms, Documents, and Records: Supplier Declaration of Conformity First Article Procedure First Article Guidelines for Intermec Suppliers Intermec Product Environmental Compliance Requirements Supplier Declarable Substances Audit Checklist Supplier Declarable Substances Self-Assessment Checklist Vendor Quality System Requirements Procedure Intermec RoHS Compliance Requirements Company Proprietary

2 Table of Contents 1.0 PURPOSE SCOPE GENERAL REQUIREMENTS REFERENCE NAME OF SUPPLIER COMPLIANCE DOCUMENTATION (SCOMPDOC) DOCUMENTATION PROCESS Incremental Documentation Stand-Alone SCompDoc and Equivalent... Error! Bookmark not defined Supplier Implementation of SCompDoc... Error! Bookmark not defined Questions Regarding SCompDoc... Error! Bookmark not defined. 4.0 SCOMPDOC REQUIREMENTS PROOF OF COMPLIANCE REQUIREMENTS Reference of Compliance Documentation of Declarable Substances Manufacturing and Storage Processes Supplier Declaration of Conformity Storage of Compliance Records FORMAL REQUIREMENTS SELF-ASSESSMENT REQUIREMENTS SELF-ASSESSMENT CHECKLIST SELF-ASSESSMENT SCHEDULE INTERMEC SELF-ASSESSMENT RECORD KEEPING AUDIT REQUIREMENTS AUDIT CHECKLIST AUDIT SCHEDULE RE-AUDITS INTERMEC AUDIT RECORD KEEPING...6 GLOSSARY...7 REVISION HISTORY...8 Document Number: Rev. E Page 2 of 8

3 1.0 PURPOSE Defines the documentation Intermec s direct suppliers must keep in order to meet Intermec s requirements for full Declarable Substance compliance. 2.0 SCOPE This procedure defines the minimum requirements for obtaining, storing, creating, distributing, auditing, and controlling changes to, records documenting compliance with Intermec Declarable Substances compliance requirements. 3.0 GENERAL REQUIREMENTS 3.1 Reference Name of Supplier Compliance Documentation (SCompDoc) From here on the Supplier (Declarable Substances) Compliance Documentation will be called SCompDoc. 3.2 Documentation Process Each direct Intermec supplier is required to maintain a documented process for obtaining, storing, creating, distributing, auditing, and controlling changes to, records documenting Declarable Substances compliance. These records shall constitute the supplier s proof of compliance for all products the supplier sells to Intermec Incremental Documentation Intermec uses an incremental Declarable Substances compliance documentation system: Each direct Intermec supplier is required to keep on file adequate compliance documentation at the level of, and for all, the components and materials the supplier uses to produce each Part Number the supplier sells to Intermec SCompDoc System Requirements The documented process described in 3.2 shall meet the standards for document control and records management as described in ISO 9001 and Doc # Vendor Quality System Requirements. Document Number: Rev. E Page 3 of 8

4 4.0 SCOMPDOC REQUIREMENTS 4.1 Proof of Compliance Requirements To qualify as Proof of Compliance, the SCompDoc must contain, at a minimum, the information listed below Reference of Compliance A reference of compliance to Doc # Intermec Product Environmental Compliance Requirements must be present to identify the purpose of the SCompDoc Documentation of Declarable Substances The presence, if in excess of applicable regulatory thresholds, of Declarable substances in materials and products purchased by the supplier for use in products the supplier sells to Intermec, must be documented according to Intermec Supplier Substance Declaration Requirements Manufacturing and Storage Processes Proof of compliance must be maintained for all of the supplier s manufacturing and storage processes used during the construction and handling of Declarable Substances compliant material and products the supplier sells to Intermec. Note: Intermec documents containing references to Doc # Intermec Product Environmental Compliance Requirements may include, but are not limited to Product Specifications Bills of Materials Drawings Revision History Documents (RHD) Purchase Orders Purchase Agreements Electronic data files Supplier Declaration of Conformity The Supplier must provide to Intermec a Declarable substance declaration according to Intermec s Doc # First Article Procedure AND Doc # First Article Guidelines for Intermec Suppliers Storage of Compliance Records Documentation supporting compliance must be stored for a minimum of ten years. 4.2 Formal Requirements The SCompDoc must contain the following formal elements, at a minimum and meet the requirements of 3.2.2: Document Number: Rev. E Page 4 of 8

5 4.2.1 A section describing how change control for Declarable Substance compliant materials will be handled. This may be a reference to an existing change control process A listing of the types of data/declarations required to prove that a supplier s Declarable Substances declaration is valid. This applies to any material a direct supplier of Intermec purchases and handles for the purpose of selling it to Intermec as Declarable Substances compliant. See Proof of Compliance Requirements, in this document A decision tree used to determine if laboratory analysis is required to prove compliance with Doc # Intermec Product Environmental Compliance Requirements References to industry standards used when testing is performed for Declarable Substances compliance. For representative test methodologies, refer to applicable substance regulationspecific requirements documents referenced in Intermec Doc # Intermec Product Environmental Compliance Requirements A description of the receiving process for material that is required to be Declarable Substances compliant, or reference to an established receiving process that contains references to receiving Declarable Substances compliant material. The inspection instructions directly relating to Declarable Substances compliance must contain a reference to Declarable Substances compliance A section describing storage and security of Declarable Substances compliant material. Material must be stored to prevent contamination with Declarable substances A section describing handling and marking requirements for Declarable Substances compliant material. Material must be handled to prevent contamination with Declarable substances A section describing segregation requirements for - Declarable Substances compliant material and non-compliant material differentiated by part number Declarable Substances compliant material and non-compliant material differentiated by date code or lot code only A section describing measures to prevent manufacturing processes from intentionally introducing Declarable substances. This section must contain quality check points to confirm Declarable substances have not intentionally been introduced A section describing the change control applicable to the SCompDoc itself A Revision History tracking system that includes a short description of the change and the approval date, signed by both the supplier and Intermec. Revisions must be approved by Intermec. 5.0 SELF-ASSESSMENT REQUIREMENTS 5.1 Self-Assessment Checklist For self-assessment of the SCompDoc use Intermec Form # , Supplier Declarable Substances Self-Assessment Checklist. 5.2 Self-Assessment Schedule The self-assessment schedule will be determined and agreed upon by both Intermec and the supplier. 5.3 Intermec Self-Assessment Record Keeping Document Number: Rev. E Page 5 of 8

6 The completed Form # will be kept by Intermec in the appropriate vendor folder in; AllItems.aspx. See Retention of Records Procedure for retention duration. 6.0 AUDIT REQUIREMENTS 6.1 Audit Checklist For audits of the SCompDoc Intermec uses Form # , Supplier Declarable Substances Audit Checklist. 6.2 Audit Schedule The audit schedule will be determined and agreed upon by both Intermec and the supplier. For audit purposes, the SCompDoc must be made available to Intermec personnel upon request. 6.3 Re-Audits Any system-level changes in an approved supplier s SCompDoc system will be reviewed by Intermec and may result in a re-audit. 6.4 Intermec Audit Record Keeping The completed Form # will be kept by Intermec according to the provisions of Form # Document Number: Rev. E Page 6 of 8

7 Glossary Homogenous material PO Declarable Substances SCompDoc See Intermec Doc # Intermec Product Environmental Compliance Requirements Purchase Order See Intermec Doc # Intermec Product Environmental Compliance Requirements Supplier Compliance Documentation: Refers to the Declarable Substances compliance documentation maintained by Intermec s direct suppliers Document Number: Rev. E Page 7 of 8

8 Revision History Revision Purpose Of Change Document Date Author A Initial Release 08/6/05 Carson Schlamp B C D E Corrected misnumbered paragraphs. Changed abbreviation RoHS DOC to SA RoHS DOC for better differentiation. Updated with Plexus and Venture Declaration of Conformity, miscellaneous updates to clarify procedure, added recordkeeping; Updated cover page and approvers. Para. 3.1, , , 3.3, 3.3.1, 3.3.2, 3.8, 5.0, Appendix A. Adapted entire document to multi-jurisdiction Declarable Substance Compliance Requirements Eliminated all RoHS references Eliminated all texts redundant to texts in referenced documents Clarified and tightened subject groups, renumbered sections accordingly Eliminated references to Plexus and Venture Declaration of Conformity Added section Self-Assessment Requirements Updated approvers, Reference documents & the title for Changed to include FMD and RCD. Changed to reference ISO 9001 and Removed & Update to reference Updated to 10 years retention. Removed a number of subsections of 4.2 that are part of a normal QMS. Replaced restricted with declarable throughout. 12/28/05 Carson Schlamp 7/13/06 Peggy Larsen 06 JUN 07 Stefan Truemper 4/12/12 Larry Graham Document Number: Rev. E Page 8 of 8