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Quality Manual
This manual is the property of Dill Air Controls Products. It may not be reproduced in whole or in part or otherwise disclosed without prior consent from the Quality Assurance Manager.
Level I Cover
QUALITY MANUAL Procedure No. QM-TC Revision Level M
TITLE: QM-TC TABLE OF CONTENTS Revision Date 1/7/11 Page No. 1 of 1
Document Title / Revision Level ISO / TS specification QM-TC Table of Contents / Rev M QM-QP Quality Policy / June 2006 QM-A Quality Management System Scope / Rev H QM-C Dill Air Controls Products Process Flow / (January, 2008) QM-B Quality Management Procedures QP-05-01 Control of Documents 4.2.3 QP-16-01 Control of Records 4.2.4 QP-18-01 Training 6.2.2.2 QP-17-01 Internal Quality Audits 8.2.2 QP-13-01 Control of Non-Conforming Product 8.3 QP-14-01 Corrective Action 8.5.2 QP-14-03 Preventive Action 8.5.3 QM-D Dill Air Controls Products Organizational Chart / (January 2011) Basic New for Air Controls Division
A QM-01 Rev level was “Basic” 4/8/04 L. Schlesinger B QM-A, QM-B,QM-01 Rev level was “A”, All other Rev levels were “Basic” 7/6/05 R. Buhr C QM-01 was rev. B 1/6/06 R. Buhr D QM-B, QM-01, QM-02, QM-06, QM-09, QM-15 updated at review 2/27/06 R. Buhr E Totally revised for TS 16949 6/21/06 R. Buhr F Scope revised for exclusion of service provision. 7/6/06 R. Buhr G Organizational Chart updated 8/07 R. Buhr H Organization Chart Up-dated 5/08 R. Buhr I Organization Chart Up-dated 10/08 R. Buhr J Scope updated to ISO 9001:2008 6/09 R. Buhr K Organization Chart Up-dated 12/09 R. Buhr L Organization Chart Up-dated 6/10 R. Buhr M Organization Chart Up-dated 1/11 R. Buhr
“Destroy Previous Revision Level”
Dill Air Controls Products, LLC
“Quality Policy”
“It is the policy of Dill Air Controls Products to
meet or exceed Internal and External Customer
Expectations by providing superior Products and
Services. We do this by focusing on Customer-led
Quality Objectives and continually improving
The Quality Management System.”
QM-QP June 2006
Air
Controls
Products
QUALITY MANUAL Section QM-A Revision Level H
TITLE: QM-A QUALITY MANAGEMENT SYSTEM SCOPE Revision Date 6/15/09 Page No. 1 of 2
Dill Air Controls Products, LLC (Dill), headquartered in Oxford, North Carolina, has established a quality management system that satisfies the needs of its customers and assures continuous improvement. The quality management system covers the design, manufacturing, verification and delivery of our products and complies with internationally recognized quality system standard ISO/TS 16949:2002 with registration to ISO 9001:2008. The Quality System supports Dill with design, manufacturing & sales responsibility located in Oxford, NC serving both OEM and Aftermarket agents for air control products. A Quality Manual has been prepared which describes the quality system for Dill. The manual is a source of reference for Quality System Procedures, which define responsibilities concerned with the operation and monitoring of the quality system, and assists in the training and education of new staff in matters relating to quality. Dill does not have service agreements with customers and does not provide service centers, special tools or measuring equipment, or offer training of service personnel. Section 7.5.1.8 of TS16949 to be excluded from the quality system. The Quality Manual provides customers an understanding of Dill's commitment to quality and confidence in the capabilities of the company to produce a quality product. The Quality Manual and Quality System Procedures are electronically maintained by the Quality Assurance Department. Controlled copies are issued upon request. This Quality Manual is hereby formally authorized and approved by the undersigned. Name: Position: Date: _____________ General Manager _______ Brian Rigney _____________ Operations Manager _______ Tony Monfrado _____________ Engineering Manager _______ Larry Schlesinger _____________ Sales and Marketing Manager _______ Brian Rigney (interim) _____________ Sales _______ Joe Hebert _____________ Quality Manager _______ Richard Buhr _____________ Controller _______
QUALITY MANUAL Section QM-A Revision Level H
TITLE: QM-A QUALITY MANAGEMENT SYSTEM SCOPE Revision Date 6/15/09 Page No. 2 of 2
Kathleen Myers (ELECTRONIC USERS: Signatures on file in Quality Department) Basic New for Air Controls Division A Corrected document numbers in Level II per DNV finding – 9/16/02 B Eaton Air Controls Division changed to Dill Air Controls Products 7/6/05 C Roxboro, NC changed to Oxford, NC for new location of business 2/27/06 D Totally revised for TS 16949 6/7/06 E Changed approvals for all staff 6/21/06 F Added exclusion of servicing provisions. 7/6/06 G Revised for change in General Manager 6/23/08 H Revised to new ISO 9001:2008 standard 6/15/09 “Destroy Previous Revision Level”
Monday, January 28, 2008
Page 1
DILL ACP PROCESS FLOW
MARKET ANALYSISQMS-P-001
CONTRACT REVIEW
QMS-P-003
PRODUCT DEVELOPMENT
QMS-P-002
ORDER ENTRYQMS-P-004
CUSTOMER SURVEYS
CUSTOMER REQUEST FOR
QUOTE
CUSTOMER NEED
/ APPROVALS
CUSTOMER ORDER
QUANTITY NEED DELIVERY NEED
STRATEGY &PLANNING
FORECAST ADVERTISING
DETERMINE CAPACITY &
TRAININGQP-18-01
DETERMINE AND ORDER TOOLING
AND GAGING
DEVELOP BILLS AND ROUTINGS
DEVELOP AND POST COSTING
DEVELOP AQP
MAKE /TEST PROTOTYPE / PILOT PARTS
IT SUPPORT
LAYOUT / PPAP
QUALIFY SUPPLIERS
ORDER PARTS, MATERIALS AND
PRODUCTION SERVICES
SUPPLIERS
SCHEDULE ORDER
SPECIFICATIONS AND DRAWINGS
QP-05-01QP-16-01
RELEASE ORDER WITH
SPECIFICATIONS
REQUISITION PARTS /
MATERIALS
B
C
D
A
F
G
G
A
SETUP
SETUP APPROVAL
INSPECT PRODUCTQP-13-01
PACKAGE AND LABEL PRODUCT
STORE PRODUCT
PRODUCE PRODUCTQMS-P-006
RECEIVE RAW MATERIAL AND
PARTSQMS-P-005
INSPECT RAW MATERIALS AND
PARTS
STORE RAW MATERIAL AND
PARTS
PICK REQUISITIONS
SUPPLIERS
RECEIVE INVOICES
PAY INVOICES
PICK ORDER
INSPECT ORDERQP-13-01
PACK AND LABEL ORDER
SHIP ORDERQMS-P-007
INVOICE ORDER
QMS-P-007
EVALUATE PERFORMANCE
QMS-P-008
CUSTOMER PAYMENT
COLLECT PAYMENT
SCHEDULE LABOR
HR SUPPORT
CUSTOMER SURVEY
SUPPLIERS
Monday, January 28, 2008
Page 2
DILL ACP PROCESS FLOW
B C
D
CUSTOMER
GRADE SUPPLIERS(SUPPLIERQUALITYMANUAL)
F
G
IT SUPPORT
G
FACILITIES AND TOOLING SUPPORT
G
LAYERED PROCESS
AUDITS
E
EINTERNAL
AUDITSQP-17-01
CORRECTIVE ACTIONSQP-14-01
PREVENTIVE ACTIONSQP-14-03
H
H
QUALITY PROCEDURE Procedure No. QP-05-01 Revision Level F
TITLE: QP-05-01 DOCUMENT CONTROL Revision Date 6/30/08 Page No. 1 of 4
1. PURPOSE The purpose of this procedure is to define the control methods for the quality system documentation, when required, and assign responsibility for establishment, review, authorization, issue, distribution, and revisions of controlled documents. 2. APPLICATION This table represents an overview of the quality system documentation. For specific document contents see Quality System Documentation Procedure. Additional documents requiring control are covered within individual work instructions and control is defined within that work instruction document. Section 6.0 of this procedure applies to all categories of controlled quality system documents Dill Air Controls Products
DOCUMENT CONTROL TABLE DOC LEVEL
DOCUMENT CATEGORY
DOCUMENT TYPE
APPROVAL AUTHORITY
ISSUING FUNCTION
I
Quality Manual
Quality Manual
Operation Staff
Quality Assurance
II
Quality Procedures
Quality Procedures
Applicable department manager or designee
Quality Assurance
III
Work Instructions
Work instructions for manufacturing operations Work instructions for administrative operations
See document control work instructions. Applicable department manager or designee
See document control work instructions. Applicable department manager or designee
III
External Standards
Drawings Material Quality Industrial Government Other
Publisher Government
Product Engineering, Quality Assurance
III
Product Drawings and Specifications
Product Drawings Product Specifications
Prod. Engineering See applicable specification work instructions
Prod. Engineering Prod. Engineering
III
Quality Planning Documents
Control Plan Process Flow Chart P.F.M.E.A. Characteristic Matrix D.F.M.E.A.
See document control work instructions. Prod. Engineering
See document control work instructions. Prod. Engineering
III
Customer Drawings and Specifications
Customer Drawings and Specifications
Customer
Prod. Engineering
Other
Business Planning Documents
Customer Specific Requirements
Others
Division Strategic Business Plan
Customer Published Manuals
As defined by Internal Quality System documentation
Strategic Planning &
Market Development Mgr.
Customer
Applicable department manager or designee
Marketing
Quality Assurance
Applicable department manager or designee
QUALITY PROCEDURE Procedure No. QP-05-01 Revision Level F
TITLE: QP-05-01 DOCUMENT CONTROL Revision Date 6/30/08 Page No. 2 of 4
3. RESPONSIBILITIES The functions responsible for approving and issuing quality system documentation are shown in the Document Control table. 4. REFERENCE DOCUMENTS a) TS-WI-7.3.6.3-01 - Production Part Approval Work Process Work Instruction 5. DEFINITIONS PFMEA: Process Failure Modes & Effects Analysis DFMEA: Design Failure Modes & Effects Analysis 6. PROCEDURE
6.1. General
6.1.1. Anyone in DILL ACP can request the issue of a new document or the revision of an existing one. The person submits a draft of the proposed document to the appropriate approval authority.
6.1.2. Currently released documents referenced by customer specifications and drawings are
available at the manufacturing locations.
6.1.3. The designated reviewing functions have access to pertinent background information to facilitate the review.
6.1.4. The review, update and re-approval of documents to be performed as required and
verified by approval and date of ECR.
6.2. Document Approval
6.2.1. The issuing function ensures the document draft is reviewed and approved for adequacy, prior to issue, by the approval authority listed in the table. Document revisions are reviewed and approved by the same function(s) that approved the initial release unless specifically designated otherwise. This document revision review/approval may be in the form of a ballot process or other methods specified by the appropriate issuing function in their work instruction. Administrative changes to the Quality Documents may be made and approved by the appropriate approval authority. An administrative change is defined as a change where intent is not affected and may include, but is not limited to: changes in grammar, correction of spelling errors, adding reference document notations, and/or minor wording changes that do not affect intent as determined by the appropriate approval authority, (the flow chart process is not applicable for changes of this nature).
6.2.2. Documents being circulated for approval are appropriately identified to prevent
unintended use.
6.2.3. Handwritten revisions to released documents must be signed and dated by the applicable approval authority and, if permanently adopted, must be replaced with formally changed documents as soon as reasonable time permits.
6.2.4. Temporary work instructions other than released documents must be controlled and
signed by the approving authority.
QUALITY PROCEDURE Procedure No. QP-05-01 Revision Level F
TITLE: QP-05-01 DOCUMENT CONTROL Revision Date 6/30/08 Page No. 3 of 4
6.2.5. The following flow chart graphically illustrates the process for creation, revision and approval of quality system documents.
Procedure Flow Chart
Control DocumentIdentified
(Add, Delete, Modify)
DocumentProposal Made
Submit for Review
DocumentReview Accepted
/ Rejected
Reject
Accept
Submit forApproval
Accept
DocumentApproval
Accepted /Rejected
See ApprovalAuthority In
Document ControlTable
Identify ControlMethod & Update
System
See IssuingFunction In
Document ControlTable
Notification
See IssuingFunction In
Document ControlTable
Formal TrainingRequired?
Yes
No
See IssuingFunction In
Document ControlTable
Implement Document Revision
1. Issue Req'd Copies2. Gather & Destroy
ObsoleteDocuments
Train & Record(per 4.18)
Reject / Modify
Modify
See ApprovalAuthority In
Document ControlTable
Scrap
See IssuingFunction In
Document ControlTable
QUALITY PROCEDURE Procedure No. QP-05-01 Revision Level F
TITLE: QP-05-01 DOCUMENT CONTROL Revision Date 6/30/08 Page No. 4 of 4
6.3. Document Release and Distribution
ature of the change shall be identified in the document or the appropriate attachments.
roval submissions are required in accordance with the Production Part Approval Process.
ccording to their system. These documents are available at the manufacturing location(s).
k Instructions are uncontrolled, as they are electronically controlled in the computer system.
6.3.5. Controlled documents are identified by individual Manufacturing Orders.
6.3.6. The issuing function is responsible for maintaining an effective control method which:
removed from the point of
6.3.6.3. ensures issued documents are readily identifiable and legible to the end user.
6.4. Obsolete and Historical Documents
e issuing function in accordance with the Control & Retention of Records Work Instruction.
Basic
6.3.1. The issuing function shall ensure released documents are identified with a title or number,
date of revision and/or revision level and a means of showing formal release appropriate to the document. Where practicable, the n
6.3.2. All customer standards/specifications and changes are reviewed, distributed, and
implemented in a timely manner, appropriate to the type of document. The date a change is implemented into production is recorded and maintained. Changes in these specifications are reviewed by Quality Assurance to determine whether customer production part app
6.3.3. Customer documents are identified by the customer a
6.3.4. Hard copies of the Quality Manual, Quality Procedures, Quality Work instructions, and
Manufacturing Wor
6.3.6.1. identifies the current revision status 6.3.6.2. ensures that any obsolete/invalid documents are promptly
issue or use, or otherwise assured against unintended use
6.4.1. Obsolete documents that are retained for preservation of knowledge or legal reasons are
identified accordingly by th
New for Air Controls Division A Corrected document numbers in Level II per DNV finding – 9/16/02 B Modified for Dill Air Controls Products 11/4/05 C Reviewed and revised for TS 16949 6/27/06 D Revised 6.1.4 for clarification of document approval and up-dated document control table
10/15/07 L. Watts E Up-Dated Reference Documents -1/24/08 F Up-dated Section 6.3.4 and 6.3.5 6/30/08 L. Watts
“Destroy Previous Revision Level”
QUALITY PROCEDURE Procedure No. QP-16-01
Revision Level D TITLE: QP-16-01 QUALITY RECORDS Revision Date 1/28/08
Page No. 1 of 2
1. PURPOSE The purpose of this procedure is to provide a system and instructions for identification, storage, protection, retrieval, retention time and disposition and disposal of quality records that are retained in support of the quality system. 2. APPLICATION This procedure applies to all records that demonstrate the effective implementation of the quality system at Dill Air Controls Products. Specific quality records from Dill Air Controls subcontractors are included. This procedure provides a list of affected records. Records can be in the form of any type of media. 3. RESPONSIBILITIES The departments/functions listed in the Record Retention Table are responsible for compliance to this procedure for each respective record. The control and maintenance of the Record Retention Table is the responsibility of the Quality Manager at Dill Air Controls. 4. REFERENCE DOCUMENTS
4.1. TS-WI-4.2-01 – Record Retention Table 5. PROCEDURE
5.1. Scope
5.1.1. Quality records are listed in the Record Retention Table. The records are maintained and are available for customer evaluation except in the case of confidentiality. Governmental or customer requirements may supersede these requirements.
5.2. Identification
5.2.1. Records are identifiable to the product, person, or events to which they pertain. Records
are legible, dated and identify who established the record. Records are collected, and filed in logical groupings relating to the activity to facilitate their retrieval/access. Where records contain confidential information they are marked to indicate their confidential nature.
5.3. Storage/Maintenance
5.3.1. Records are stored in dry, organized environments. Record containers are labeled as to
their contents. To insure retrievability/access, records and other quality documents are not to be stored in locations that would inhibit required access. When electronic media is used, back up methods are employed to prevent loss.
QUALITY PROCEDURE Procedure No. QP-16-01
Revision Level D TITLE: QP-16-01 QUALITY RECORDS Revision Date 1/28/08
Page No. 2 of 2
5.3.2. Records and/or storage containers are identified to ensure the following:
5.3.2.1. Name of record or area to which the record applies, e.g. "Inspection Check List" 5.3.2.2. Dates to which the records apply 5.3.2.3. Disposal and/or retention date
6. Record
6.1. Quality records are maintained for the minimum required time as set forth in the Record Retention Table. The disposal method is determined by the Management Representative or issuing authority and may include recycling for hard copies.
Basic New for Air Controls Division A Corrected document numbers in Level II per DNV finding – 9/16/02 B Modified for Dill Air Controls Products - 11/04/05 C Reviewed and Revised for TS 16949 -6/21/06 D Up-dated Reference Documents – 1/28/08
“Destroy Previous Revision Level”
QUALITY PROCEDURE Procedure No. QP-18-01 Revision Level E
TITLE: QP-18-01 TRAINING Revision Date 1/28/08 Page No. 1 of 2
1. PURPOSE The purpose of this procedure is to provide a system and instructions for determining training needs, providing training and assessing training effectiveness. 2. APPLICATION At Dill Air Controls Products, training is viewed as a strategic issue affecting all personnel, including contract and agency personnel. 3. RESPONSIBILITIES The Staff is responsible for compliance to this procedure. 4. REFERENCE DOCUMENTS
4.1. TS-WI-4.2-01 – Control & Retention of Records Work Instruction 4.2. TS-WI-5.6-01 - Management Review Work Instruction
5. PROCEDURE
5.1. General
5.1.1. Personnel (including temporary and contract employees) performing specific tasks are qualified through appropriate education, training, and/or experience as required by the qualification requirements.
5.2. Qualifications of Personnel
5.2.1. Qualification requirements are developed for specific tasks by the area supervisor. The
Supervisor must approve the qualification requirements.
5.2.2. Personnel performing specific tasks while in training must meet the following conditions:
5.2.2.1. The employee has completed the job orientation. 5.2.2.2. At least one qualified employee in the immediate area has been assigned to answer
questions, and provide any needed assistance.
5.2.3. Personnel move from "in training" status to qualified when they meet the qualification requirements. The supervisor and/or designated trainer must signoff that the appropriate training has been successfully completed and meets the required training and experience defined by the qualification requirements.
5.2.4. Personnel meeting the qualification requirements are deemed qualified as of the
implementation date of this procedure.
5.2.5. Employees not meeting the qualifications are considered "in training” and adhere to the conditions mentioned above.
QUALITY PROCEDURE Procedure No. QP-18-01 Revision Level E
TITLE: QP-18-01 TRAINING Revision Date 1/28/08 Page No. 2 of 2
5.3. Training Needs
5.3.1. The facilities training needs are assessed annually by supervisors, departmental managers and area representatives through a minimum of one or more of the following:
5.3.1.1. A review of qualification requirements and/or annual surveys 5.3.1.2. A review of plant goals and objectives 5.3.1.3. A review of Government regulations 5.3.1.4. A review of our customer's future expectations
5.4. Training Programs
5.4.1. The employee orientation training familiarizes employees with issues such as working
hours, benefits, safety, and a general explanation of the quality system.
5.4.2. Training programs (provided both internally and externally) are tracked by the Training function.
5.4.3. Employee meetings are held regularly to communicate the relevance and importance of
their activities and how they contribute to the achievement of quality objectives and business success.
5.5. Training Effectiveness
5.5.1. Training effectiveness is evaluated periodically through various methods as applicable.
Examples may include:
5.5.1.1. Periodic surveys - evaluations of task performance 5.5.1.2. Pre-testing and post testing on selected courses 5.5.1.3. Meeting plant goals - business performance
5.6. Information on effectiveness is documented and used in the development of subsequent training
plans. 6. RECORDS
6.1. A training record is established and maintained for each employee to show evidence of qualification.
6.2. Training records are maintained in accordance with the Quality Records Procedure.
Basic New for Air Controls Division A Corrected document numbers in Level II per DNV finding – 9/16/02 B Modified for Dill Air Controls Products-11/4/05 R. Buhr C Revised per CRN 10181 -2/24/06 T. Monfrado D Reviewed and revised per TS 16949 -6/27/06 E Added 5.4.3 1/28/08 L. Watts
“Destroy Previous Revision Level”
QUALITY PROCEDURE Procedure No. QP-17-01 Revision Level D TITLE: QP-17-01 INTERNAL QUALITY AUDITS Revision Date 1/28/08
Page No. 1 of 2
1. PURPOSE The purpose of this procedure is to define a system and provide instructions for planning and conducting internal quality audits to determine whether quality activities and associated results comply with planned arrangements and to determine the effectiveness of the quality system. 2. APPLICATION This procedure applies to all activities within the quality system. 3. RESPONSIBILITIES The Quality Assurance function is responsible for managing the internal audit process. Audited departments/functions are responsible for developing and implementing corrective actions to address noncompliances found. 4. REFERENCE DOCUMENTS
4.1. TS-WI-8.5-02 - Corrective Actions Work Instruction 4.2. TS-WI-4.2-01 – Control & Retention of Records Work Instruction 4.3. TS-WI-5.6-01 - Management Review Work Instruction 4.4. QMS-P-006 – Produce Product Process Flow
5. PROCEDURE
5.1. Planning
5.1.1. The Quality Assurance function is responsible for planning and scheduling the internal audits. A complete audit of all quality system elements including all active shifts is conducted at least once a year. The audits are completed in accordance with a documented schedule which is based on the status and importance of the activity, taking into account an increased frequency when internal and external nonconformances, customer complaints or past audit results reveal compliance concerns.
5.2. Audit Team
5.2.1. The Quality Assurance function assigns qualified personnel to carry out internal audits.
Assigned auditors are independent of those having direct responsibility for the audited activity. Auditors sourced from outside the organization must meet these requirements.
5.2.2. The evidence of auditor qualifications is retained according to the Quality Records
Procedure.
5.3. Preparation for Audit
5.3.1. Audit checklists are developed taking into consideration the customer audit requirements, the quality manual and referenced procedures, the noncompliance reports and corrective action files and, as appropriate, specifically prepared questions.
QUALITY PROCEDURE Procedure No. QP-17-01 Revision Level D TITLE: QP-17-01 INTERNAL QUALITY AUDITS Revision Date 1/28/08
Page No. 2 of 2
5.4. Conducting the Audit
5.4.1. The manager(s) responsible for the area being audited is notified in advance. 5.4.2. The auditors use the audit checklist and seek objective evidence demonstrating whether
the audited activities comply with the requirements of the documented quality system. The results of the audit are documented on an audit report and discussed with the responsible function(s).
5.5. Audit Review
5.5.1. The area manager's acknowledgement of review (signature) is required on the audit report.
5.5.2. Management, according to the Management Review Work Instruction reviews internal
audit results.
5.6. Corrective Action and Follow-Up
5.6.1. When noncompliances are identified and documented, the area manager is responsible for investigation of the problem(s) noted as a noncompliance, and taking timely corrective action according to the Corrective Action Work Instruction.
5.6.2. Following implementation, or at the next scheduled audit, an auditor follows up to
determine if the corrective action has been implemented and if it is effective. Objective evidence is reviewed and recorded in the audit results. If more work is needed to implement the action, a new follow-up date is agreed upon and documented.
6. RECORDS
6.1. The audit reports and corrective actions are documented and maintained according to the Control & Retention of Records Work Instruction.
Basic New for Air Controls Division A Corrected document numbers in Level II per DNV finding – 9/16/02 B Modified for Dill Air Controls Products- 11/4/05 C Reviewed for TS 16949 – 6/21/06 D Up-Dated Reference Documents -1/24/08 “Destroy Previous Revision Level”
QUALITY PROCEDURE Procedure No. QP-13-01 Revision Level D
TITLE: QP-13-01 CONTROL OF Revision Date 1/28/08 NONCONFORMING PRODUCT Page No. 1 of 3
1. PURPOSE The purpose of this procedure is to provide a system and instructions for identification, documentation, evaluation, segregation, and disposition of suspect and confirmed nonconforming products and materials to prevent unintended use or installation into an assembly. 2. APPLICATION Any Non-conforming or Suspect Product or Material, which does not meet, required specifications. 3. RESPONSIBILITIES It is the responsibility of personnel conducting inspection or testing to identify, document, and segregate non-conforming or suspect material. The material review authority is responsible for evaluation, disposition, and/or notification of non-conforming or suspect material 4. REFERENCE DOCUMENTS
4.1. TS-WI-8.5-02 - Corrective Actions Work Instruction 4.2. TS-WI-7.3.6.3-01 - Production Part Approval Work Instruction 4.3. TS-WI-4.2-01 – Control & Retention of Records Work Instruction 4.4. TS-WI-7.5.3-01 - Product Identification Work Instruction 4.5. TS-WI-7.5.3-02 – Product Traceability Work Instruction 4.6. QMS-P-006 – Produce Product Process Flow
5. PROCEDURE
5.1. Identification and Documentation
5.1.1. Personnel who conduct inspection or testing are responsible for visually identifying non-conforming and suspect products in the course of their activities.
5.1.2. When nonconforming or suspect product is identified, it is visually labeled as
nonconforming and it is segregated (when practical) to prevent unintended use. The nonconforming product is identified according to the Product Identification and Traceability Work Instructions. The material review authority is notified.
5.1.3. Information to Management - When products and/or processes become noncompliant to
requirements Quality Assurance function is notified. The Quality Assurance Function will evaluate the nonconformance and promptly notify the facility management as appropriate based on the severity of the nonconformance and those affected. When non-conforming product is detected after delivery or use has started, all suspect product and components will be contained for evaluation. Dill will notify the customer to the effects or potential effects of the non-conformity.
5.1.4. Where containment areas exist, they are visually marked with a placard or other visible
indicator.
QUALITY PROCEDURE Procedure No. QP-13-01 Revision Level D
TITLE: QP-13-01 CONTROL OF Revision Date 1/28/08 NONCONFORMING PRODUCT Page No. 2 of 3
5.2. Nonconformity Review and Disposition
5.2.1. The material review authority will manage the review and disposition of nonconforming products in the following manner:
5.2.1.1. Reworked to meet the specified requirements, 5.2.1.2. Accepted as-is, with or without repair (providing customer approval is obtained where
required by contract), 5.2.1.3. Accept as-is, providing customer requirements are met, 5.2.1.4. Re-grade (use in an alternative application in which it meets customer requirements), 5.2.1.5. Scrapped
5.2.2. The disposition and corrective actions are completed according to the Corrective Action
Work Instruction.
5.2.3. These dispositions are approved by the Quality Assurance function and are documented in the Control Plan and/or appropriate control document.
5.2.4. Once disposition is determined the material review authority identifies the product
according to the Product Identification and Traceability Work Instruction.
5.3. Reworked and Repaired Product
5.3.1. Documented work instructions at the workstation are utilized in the reclamation of product according to the Control Plan and/or appropriate control document using appropriately trained personnel. The system assures that no rework or repair can be visible on the exterior of the product supplied for non-original equipment service applications without prior approval of the customer service parts organization.
5.3.2. When required by contract, the customer is notified by Sales, Quality Assurance, or
Product Engineering for concurrence to accept nonconforming product or the proposed repairs that would affect the product quality.
5.3.3. The facility staff establishes a rework reduction plan. Data on nonconforming material that
is subject to rework is compiled and analyzed. Priorities are determined and action plans developed in conjunction with any ongoing corrective/preventive actions. Progress toward the plan is tracked through trend and/or Pareto charts.
5.4. Re-inspection
5.4.1. Repaired or reworked products are inspected according to the Control Plan and/or
appropriate control document to verify that they comply with specified requirements.
5.5. Customer Engineering Approval - Product Authorization
5.5.1. In accordance with customer requirements, prior written approval is obtained through Sales, Quality Assurance, or Product Engineering whenever the product or process is different from that currently approved per the Production Part Approval Work Instruction. This applies equally to products or services purchased from subcontractors. Dill Air Controls Products Sales and/or Quality Assurance resolve any issues and concur with the requests of a subcontractor before submission to a customer. If authorization expires, Sales, Quality
QUALITY PROCEDURE Procedure No. QP-13-01 Revision Level D
TITLE: QP-13-01 CONTROL OF Revision Date 1/28/08 NONCONFORMING PRODUCT Page No. 3 of 3
Assurance, or Product Engineering requests written customer approval before subsequent shipment of product. Materials shipped under an authorization are identified with the authorization description clearly visible on each shipping container.
6. RECORDS
6.1. Records of nonconforming product will be maintained in accordance with the Quality Records Work Instruction.
6.2. Records of product or process changes, including expiration date and/or quantity authorized are
maintained according to the Quality Records Work Instruction. Basic New for Air Controls Division A Corrected document numbers in Level II per DNV finding – 9/16/02 B Modified for Dill Air Controls Products -11/4/05 C Reviewed and revised for TS 16949- 6/27/06 D Up-dated Reference Material – 1/28/08
“Destroy Previous Revision Level”
QUALITY PROCEDURE Procedure No. QP-14-01 Revision Level D
TITLE: QP-14-01 CORRECTIVE ACTION Revision Date 1/28/08 Page No. 1 of 3
1. PURPOSE The purpose of this procedure is to provide for a system and instructions for initiating, carrying out, and verifying the effectiveness of corrective actions. 2. APPLICATION This procedure applies to correcting nonconformities related to materials, components, subassemblies, finished products, packaging, production processes, and the quality system. 3. RESPONSIBILITIES All functions are responsible for the effective deployment and maintenance of corrective actions. 4. REFERENCE DOCUMENTS
4.1. TS-WI-8.3-01 - Control of Nonconforming Product and MRB Work Instruction 4.2. TS-WI-4.2-02 - Document Control Work Instruction 4.3. TS-WI-7.1-01 – Engineering Change Control Work Instruction 4.4. TS-WI-4.2-01 – Control & Retention of Records Work Instruction 4.5. TS-WI-5.6-01 - Management Review Work Instruction 4.6. QMS-P-006 – Produce Product Process Flow
5. PROCESS
5.1. Corrective Action Requests for Subcontractors
5.1.1. When nonconforming purchased parts, materials or services incorporated in the finish product are found they are documented according to the Control of Nonconforming Product & MRB Work Instruction.
5.1.2. Subcontractors are required to respond to Quality Assurance for the nonconforming
product with corrective action. Depending upon the degree of the problem, the Quality Assurance function may assign an approach to be taken.
5.2. Corrective Actions on In-House Nonconformities
5.2.1. Corrective actions for in-house nonconformities are performed using a disciplined structured problem solving method. Depending upon the scope of the problem and whether or not the cause is known, two formats may be used.
5.2.1.1. If the cause is known, a three-step approach may be used:
5.2.1.1.1. Define Problem 5.2.1.1.2. Implement Permanent Actions 5.2.1.1.3. Verify Effectiveness of Permanent Actions
QUALITY PROCEDURE Procedure No. QP-14-01 Revision Level D
TITLE: QP-14-01 CORRECTIVE ACTION Revision Date 1/28/08 Page No. 2 of 3
5.2.1.2. If the cause is not known, an eight-step approach is used: 5.2.1.2.1. Form Team 5.2.1.2.2. Define Problem 5.2.1.2.3. Implement Containment Action 5.2.1.2.4. Define/Verify Root Cause 5.2.1.2.5. Choose/Verify Permanent Actions 5.2.1.2.6. Implement/Validate Permanent Actions 5.2.1.2.7. Prevent Recurrence 5.2.1.2.8. Congratulate Team
5.2.2. Mistake Proofing
5.2.2.1. Prior to the closing/completion of a corrective action mistake proofing methodology is
considered and implemented where appropriate.
5.3. Corrective Actions on External Nonconformities
5.3.1. Quality Assurance ensures that corrective actions on external nonconformities are addressed in a manner and format compliant with any customer specific requirements.
5.4. Returned Product Test/Analysis
5.4.1. Parts returned from the customer's manufacturing plants, engineering facilities, service
parts centers, and dealerships are analyzed and, as appropriate, actions are taken.
5.5. Effectiveness of Corrective Actions
5.5.1. The Quality Assurance function verifies the effectiveness of corrective actions taken.
5.6. Corrective Action Impact
5.6.1. Prior to the closing/completion of a corrective action similar products and processes are evaluated to determine if the resulting corrective actions and controls can be used to reduce the potential for producing nonconforming material. This also includes sharing corrective action information with other facilities using similar products and processes.
5.7. Process and Document Changes
5.7.1. Corrective actions involving process changes are handled in accordance with the
Engineering Change Control Work Instruction. Changes to documents are implemented and recorded according to the Document Control Work Instruction.
5.8. Review
5.8.1. Review of corrective actions and effective implementation is conducted according to the
Management Review Work Instruction.
QUALITY PROCEDURE Procedure No. QP-14-01 Revision Level D
TITLE: QP-14-01 CORRECTIVE ACTION Revision Date 1/28/08 Page No. 3 of 3
6.0 RECORDS
6.1 Corrective action records and returned product analyses are maintained in accordance with the Control & Retention of Records Work Instruction.
Basic New for Air Controls Division A Corrected document numbers in Level II per DNV finding – 9/16/02 B Updated for Dill Air Controls Products- 11/4/05 C Reviewed for TS 16949 – 6/21/06 D Up-Dated Reference Documents -1/24/08 “Destroy Previous Revision Level”
QUALITY PROCEDURE Procedure No. QP-14-03 Revision Level D
TITLE: QP-14-03 PREVENTIVE ACTION Revision Date 1/28/08 Page No. 1 of 2
1. PURPOSE The purpose of this procedure is to provide a system and instructions for developing, implementing and verifying the effectiveness of preventive actions. 2. APPLICATION This procedure applies to preventing nonconformities related to materials, components and subassemblies incorporated into and including finished products, production processes, and the quality system. 3. RESPONSIBILITIES The facility management group is responsible for developing preventive action plans and complying with this procedure. 4. REFERENCE DOCUMENTS
4.1. TS-WI-7.1-01 – Engineering Change Control Work Instruction 4.2. TS-WI-4.2-02 - Document Control Work Instruction 4.3. TS-WI-5.6-01 - Management Review Work Instruction 4.4. TS-WI-4.2-01 – Control & Retention of Records Work Instruction 4.5. QMS-P-006 – Produce Product Process Flow
5. PROCEDURE
5.1. Development of Action Plan
5.1.1. Reviews by the facility management staff, using one or more of the following, result in documented preventive action plans:
5.1.1.1. Failure Modes and Effects Analysis review, specifically analyzing Special
Characteristics or characteristics with high RPN's 5.1.1.2. Customer complaints and visit reports 5.1.1.3. Process capability data, prioritizing Special Characteristics 5.1.1.4. Internal audit concerns 5.1.1.5. Audit/Test rejection rates, prioritizing Special Characteristics 5.1.1.6. Scrap and rework 5.1.1.7. Management Review
5.2. Mistake Proofing
5.2.1. Preventive actions will be performed using a multi-disciplined structured problem solving method considering mistake-proofing methodology, which will be implemented where appropriate.
5.3. Process and Document Changes
QUALITY PROCEDURE Procedure No. QP-14-03 Revision Level D
TITLE: QP-14-03 PREVENTIVE ACTION Revision Date 1/28/08 Page No. 2 of 2
5.4. When preventive actions involve process changes, they are handled in accordance with the Engineering Change Control Work Instruction. Changes to documents will be implemented and recorded according to the Document Control Work Instruction.
5.5. Review
5.5.1. Review of preventive action plans and effective implementation is conducted according to the Management Review Work Instruction.
6. RECORDS
6.1 Records of preventive actions will be kept and maintained in accordance with the Control & Retention of Records Work Instruction.
Basic New for Air Controls Division A Corrected document numbers in Level II per DNV finding – 9/16/02 B Modified for Dill Air Controls Products- 11/4/05 C Reviewed for TS 16949 – 6/21/06 D Up-Dated Reference Documents -1/24/08
“Destroy Previous Revision Level”
1
Brian RigneyGeneral Manager
ManagementRepresentative
Anthony MonfradoOperations Manager
Joseph HebertMgr – Automotive
And Industrial Sales
Brian Rigney (acting)Manager – Sales &
Marketing
Kathleen MyersController
Naomi DennyOffice Manager
and HR Specialist
Scott DonkersDanny Bova
Aftermarket Sales
(Mary Davis, Phyllis Newman, Lori Joyner, Karen Kleber)
Customer Service &Inside Sales
David MathewsFacility, Safety, Health
& EnvironmentalMargaret McAllister
Material Planner
Dennis BerryShipping Supervisor
& PlannerGary Gravitte
Tooling & Maintenance
Milton JeffriesMickey GlascockMFG Engineers
(Ben Clay &Phyllis Sanford)
Shift Supervisors
Larry SchlesingerManager - Product
Engineering
Melvin CashDean ThomasMiguel Cavas
Ren KangEngineering
Robert BradsherLead Man
Rick SimmonsIT Generalist
OPENMaterials Manager
Richard BuhrQuality Manager
Leon WattsSarah Hebert
Quality Engineer
Mike NewtonSupplier Development
Engineer
Barbara TuckDeanna Whittley
Purchasing
Dual Reporting Relationships
Richard Buhr – Brian Rigney
B Tuck– Kathleen Myers
D. Berry – Brian Rigney
Designated – Customer Representatives
January 2011