Quality Management System
1.1 Scope :
The scope of this quality manual includes the design and manufacture of electrical
switches and electronic controls. The scope for ISO 9001:2008 also includes the design
and distribution of computer input devices.
Quality Management System scope for products manufactured and supplied to
automotive customers complies with ISO/TS 16949:2009 requirements, Customer
Requirements and applicable Regulatory Requirements. Quality Management System
scope for non-automotive customers complies with ISO 9001:2008 Standard.
Manufacturing location includes Juarez, Mexico. Supporting locations are in Pleasant
Prairie and El Paso and scope includes activities related to Engineering, Procurement,
Quality, Receiving, Sales, shipping and warehousing. This Quality Manual includes applicable customer-specific requirements to define the fundamental quality management system.
1.2 Goal :
The goal of this quality manual is the development of a quality management system that
provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.
1.3 Normative References
This Quality Manual has been made according to Technical Specification ISO/TS
16949:2009 . ZF Electronics Corp. also follows applicable references and makes sure to keep latest revision active for:
ZF Electronics Corp. has no exclusions to the ISO/TS 16949 requirements (latest rev).
ZF Electronics Corp.
2.0 QUALITY POLICY
ZF Electronics Corporation is committed to the design of innovative products which meet or exceed our customers’ needs, the delivery of quality product and services, with an aim to increase the Customer satisfaction using efficient processes and through continuous improvement of the Quality System.
4.0 ORGANIZATIONAL CHARTS
ZF Electronics Corporation Pleasant Prairie / El Paso Distribution Center / Juarez
Org charts are located in the ZF Electronics Corporation Intranet.
5.0 TERMS AND DEFINITIONS
Business Plan: Controlled document that states strategic planning about quality,
productivity, and overall business effectiveness.
Concession: Written authorization from customer or similar authority for accepting /
releasing a nonconforming product/s.
Control Plan: Documented description of the system and processes required for
Design Responsible Organization: Organization with authority to establish a new, or change an existing, product specification.
Error Proofing: Product and Manufacturing process design and development to prevent manufacturing or nonconforming products.
Laboratory : Facility for inspection, test or calibration that may include, but is not limited to, chemical, metallurgical, dimensional, physical, electrical and/or reliability testing.
Laboratory Scope: Controlled document containing: Specific tests, evaluations, and calibrations that a laboratory is qualified to perform List of equipment which it uses to perform the above, and.List of methods and standards to which it performs the above
Manufacturing: Process of making or fabricating: Production materials Production or Service parts Assemblies Heat treating, welding, painting, plating, or other finishing services.
Predictive Maintenance: Activities based on process data aimed at the avoidance of
maintenance problems by prediction of likely failure modes
Preventive maintenance: Planned action to eliminate causes of equipment failure and unscheduled interruptions to production, as an output of the manufacturing process design.
Premium freight: Extra costs or charges incurred additional to contracted delivery.
QMS: Quality Management System.
Remote location: Location that supports sites and at which non-production processes occur.
Site: Location at which value-added manufacturing processes occur
Special characteristic: Product characteristic or manufacturing process parameter which can affect safety or compliance with regulations, fit, function, performance or subsequent processing of product.
A variety of instructions/forms are provided to production personnel to clearly define
processing and process monitoring requirements for product characteristics.
Monitoring and measurement devices are made available to production and QA
personnel who perform required inspections. Product monitoring/measurement is carried out in accordance with the related checklists at the work centers.
220.127.116.11 Control plan
Control plans are developed during the APQP process; see related Quality Planning
18.104.22.168 Work instructions
Work instructions are available in each work center. Part specific instructions are
developed during the APQP process and placed in the appropriate work centers.
22.214.171.124 Verification of job set-ups
Set-ups are verified by Technicians and/or quality inspectors per the documented
126.96.36.199 Preventive And Predictive Maintenance
Preventive maintenance plans are developed for key processing equipment.
Most critical facility maintenance [e.g. cooling systems and compressors] is done on
contract basis with activities and intervals included in the contract.
Spare parts requirements and ensure their availability.
Maintenance objectives: reduce unplanned downtime; implement software-based
188.8.131.52 Management Of Production Tooling
Fabrication of tools and gauges [masters] is outsourced. Engineers manage production
tooling. Tooling is verified through 1st piece part verification. Gauges are verified
through internal calibration.
Perishable tooling is adequately stored and is clearly identified relative to type/size.
Set-up instructions specify tools/gauges to use on machine and part specific basis.
Perishable tool change intervals are programmed into the machines. The machines signal operators at the designated interval.
Suppliers are responsible for design of production tools and related modifications.
Revision control is accomplished through new part numbers with any modification.
Various methods used to identify tool status, including: designated containers for used
tools, tags, marking/notes on tool containers or racks.
Outsourced tool fabrication and repair is initiated and monitored by the engineer for the related process.
184.108.40.206 Production scheduling
Production is scheduled directly from customer releases covering a four week period, but updated weekly.
220.127.116.11 Feedback from service
Service concerns would initially be evaluated by the customer and only communicated to ZF Electronics Products if it was determined that it resulted from an internal
manufacturing defect. The corrective action process would be initiated, and all
appropriate members of management would be involved in analyzing and resolving the
ZF Electronics Corp.
7.5.2 Validation of Processes: For Production And Service Provision
Capability studies are performed upon the installation of new tooling and equipment to
prove the suitability.
Production quality and efficiency data are routinely reviewed to identify and
deterioration in capability for any production process/machine.
18.104.22.168 Validation – supplemental Above validation activities cover all processes/equipment.
7.5.3 Identification And Tractability
Product brought into production with the supplier provided identification that was
verified upon receipt. Accepted processed product gets identified with a serial number
and or a date code.
22.214.171.124 Identification – supplemental
Identification methods are applied to all products throughout product realization
7.5.4 Customer Property
All customers owned property is managed as identified in the customer specific
requirements and where the property is lost, damaged or unsuitable for use is reported to the customer and records retained.
126.96.36.199 Customer-owned production tooling All customers owned production tooling is identified as required.
7.5.5 Preservation of Product
Product is identified, handled, packaged, stored and protected in a manner that prevents damage. All finished goods are shipped in product specific containers.
188.8.131.52 Storage and inventory
Condition of product in stock is assessed at appropriate planned intervals. FIFO system
is used to optimize inventory turns over time and assure stock rotation. Obsolete
products are controlled.
7.6 Control of Monitoring And Measurement Devices
Appropriate devices for product measurements are determined during quality planning
activities and identified in control plans. The Quality Department determines calibration requirements for each device or device type, documents the requirements in a dedicated database, performs or subcontracts the required calibrations, and maintains related records.
7.6.1 Measurement System Analysis
Studies have been conducted on all instrument families.
7.6.2 Calibration/verification records
Internal and external calibration records include all required information.
7.6.3 Laboratory requirements
184.108.40.206 Internal laboratory
The laboratory scope are included in the procedures in general includes calibration
activities and layout inspections. Instrument or part specific instructions collectively
provide all scope detail for each of these categories of activity.
The QA Manager assures the adequacy of instructions specifying methods of calibration
and inspection. Laboratory personnel achieve competence in performing and recording results of calibrations and inspections as defined in section 6.2 of this document.
220.127.116.11 External laboratory
Any calibration performed externally is within the ISO 17025 accredited scope of the
18.104.22.168 Manufacturing process audit Manufacturing process audits are being performed daily and monthly in each line according to the Layered Process Audits.
22.214.171.124 Product audit Product audits are performed by Quality Inspectors in a daily basis to release product.
126.96.36.199 Internal audit plans The Quality System Manager maintain an annual audit plan that covers all processes and related activities on all shifts.
188.8.131.52 Internal auditor qualification See QMS Internal Audit Procedure
8.2.3 Monitoring and Measurement of Processes See the Monitoring and Analysis Significant process events are recorded on Daily Production Sheets.
The reaction plan to not capable or unstable process conditions includes containment,
100% inspection and corrective action. These plans are approved by customers when
8.2.4 Monitoring And Measurement Of Product
Product is inspected in accordance with the related check sheet for the product at the
operation. The check sheet indicates who performed the inspections. Check sheets are
based on requirements initially established in Control Plans.
Control of nonconforming
product – supplemental The procedure specifically states that it applies to unidentified or suspect product.
8.3.2 Control of reworked product
Rework instructions are noted on the related OMS Operational Method sheets.
Frequently this involves re-processing product per standard instructions for the part #.
Post-repair repair inspection results [whether performed in-line or off-line] are recorded.
8.3.3 Customer information
Quality Manager or Engineer is responsible to promptly notify customers if it is
discovered after-the-fact that nonconforming product was inadvertently shipped.
8.3.4 Customer waiver
Nonconforming product is not further processed or shipped without a customer waiver.
This is typically only the case for product that has already been produced. In situations
where a waiver applies to future production, expiration dates or quantities are controlled through temporary processing/inspection documentation reflecting a modified part #, which in turn is reflected in the schedule.
Waiver requests from ZF Electronics suppliers are fully considered and only passed
along to the customer when ZF Electronics Products views the request as acceptable.
8.4 Analysis of Data See the Monitoring and Analysis Summary
8.4.1 Analysis and use of data See the Monitoring and Analysis Summary
8.5.1 Continual Improvement
Continual improvement can be demonstrated through progress in achieving quality
objectives and the effective/permanent resolution of actual or potential problems through corrective and preventive action.
184.108.40.206 Continual improvement Of the organization
Several processes drive continual improvement: Innovative Mfg. Nonconforming
Material Findings Report, suggestion system, audits, corrective and preventive action,
use of working level metrics within specific SBU processes.
8.5..1.2 Manufacturing process improvement Manufacturing process improvements focuses upon control and reduction of variation in product characteristics and manufacturing process parameters.
8.5.2 Corrective Action See the Corrective and Preventive Action Procedure
220.127.116.11 Problem solving The CAR form provides a disciplined approach to problem solving
18.104.22.168 Error-proofing See the “Permanent Corrective Action Taken” section of the CAR form
22.214.171.124 Corrective action impact See the “Permanent Corrective Action Taken” section of the CAR form
126.96.36.199 Returned product test/analysis
Evidence of prompt analysis and corrective action is through a combination of the
customer satisfaction reports and or CAR’s, plus internal Claim Reports and CAR’s.
8.5.3 Preventive Action See the Corrective and Preventive Action Procedure