Renco Electronics, Inc. Quality Manual · 2019. 12. 19. · Proprietary Material of Renco...

Proprietary Material of Renco Electronics Inc. FRM‐MR‐02 595 International Place, Rockledge, FL 32955 USA Rev. 6

Renco Electronics, Inc.

Quality Manual Issue: Revision 6

Approved By: Title: Date:

Edward W. Rensing President October, 2018

Travis Rensing QA & Compliance Manager October, 2018


1. Scope Company Commitment

Renco Electronics, Inc. has developed and implemented a Quality Management

System (QMS), in order to document the organizations procedures and practices,

enhance customer relations and satisfaction, as well as continually improve upon

overall quality management. We strive to understand the dynamic external and

internal factors, and the changing need & expectation of relevant interested

parties. To identify and address the risks and opportunities, by utilizing the SIPOC

process approach.

The Quality Management System shall be based and in accordance with the latest

revision of the ISO9001 standard. The QMS shall define the design, development

and overall production, of products supplied by Renco Electronics.

The content of this manual will correlate with the quality systems defined in the

ISO9001 standard. This manual shall be used as an internal guide for the

employees to understand the required components for a quality management

system.

The Quality leadership shall be responsible for maintaining the quality manual.

Each individual department leadership shall be responsible for creating, updating,

and maintaining the referenced procedures as necessary. Executive leadership

and Quality leadership shall review and approve updated revision of the quality

manual prior to issuing.


Scope of Product

Renco Electronics Inc., also known as “Renco”, designs and manufactures coils, inductors,

chokes, and transformers, using surface mount, thru‐hole, chassis mount and the latest in

magnetic component technologies.

Quality Policy

Do it right the first time

Everybody contributes to quality

Exceed customer expectations

Positive continuous improvement

2. Normative References

ISO 9000:2015, Quality management systems – Fundamentals and vocabulary

Characteristic ‐ A characteristic is a distinctive feature or property of something.

Context of the organization – all of the internal and external factors and conditions that affect its

products and services, have an influence on its QMS, and are relevant to its purpose and strategic

direction.

Correction – any action that is taken to eliminate a nonconformity, but to address root causes.

Corrective action – steps that are taken to eliminate the causes of existing nonconformities in order

to prevent recurrence of the existing nonconformities and potentially undesirable situations.

Interested party – anyone who can affect, be affected by, or believe that they are affected by a

decision or activity. It is a person, group, or organization that has an interest or a stake in a decision

or activity.

Outsource – when an outside organization to perform part of a function or process of organization.

Process approach – manage and control the processes that make up their organization, the

interaction between these processes, and the inputs and outputs that tie these processes together.

Process‐based quality management system – using process approach to manage and control how

its quality policy is implemented and how its quality objectives are achieved. A process‐based QMS

is a network of interrelated and interconnected processes.

Quality ‐ the degree to which a set of inherent characteristics fulfills a set of requirements of an

objective.

Risk – the “effect of uncertainty on an expected result” and an effect is a positive or negative

deviation from what is expected.

Risk‐based thinking refers to a coordinated set of activities and methods that organizations use to

manage and control the many risks that affect its ability to achieve objectives.


3. Terms and Definitions (only significant changes) “Exclusions” are no longer used

“Work Environment” is replaced by “Environment for the operation of processes”

“Purchased product” is replaced by “Externally provided processes, products and services”

“Supplier” is replaced by “External provider”

4. Context of the organization 4.1 Understanding the organization and its context

Top Management determine external and internal issues that are relevant to its purpose and its

strategic direction and that affect its ability to achieve the intended result(s) of its quality

management system through PEST and SWOT. The external and internal issues identified

through PEST and SWOT are continuously being monitored and reviewed.

4.1.1 External Issues – PEST Analysis:

Political Factors: 1. Tariff policy 2. Foreign Trade Regulations 3. Employment Law 4. Environmental Regulations

Economic Factors: 1. Business cycle stage 2. Globalization 3. Interests & exchange rate 4. Inflation

Social Factors: 1. Lifestyle changes. 2. Chinese New Year Holiday 3. Consumerism 4. Brand & company image

Technological Factors: 1. Ecommerce 2. Innovation 3. Speed of tech. transfer 4. New discoveries

4.1.2 Internal Issues:

1) Product and service offerings

2) Organizational structure, roles, and accountability

3) Availability of reliable qualified and competent work force

4) Policies and goals, and the strategies that are in place to achieve them

5) Assets

6) Financial capability, solvency of customers, payment terms from customers

7) Organization’s culture

4.1.3 SWOT Analysis

Internal

(or present)

1. Good quality products 2. Strong relationships with customers 3. Strong partnerships with suppliers 4. Strong engineering capabilities

1. ERP system not utilized at full capability 2. Companywide QMS communications

External

(or future) O ‐ opportunities

1. New customers for US only mfg. 2. Expand QMS scopes and certifications

1. Weather 2. Increased tariffs, and uncertainty 3. Competitive market


4.2 Understanding the needs and expectations of interested parties

Top Management determine relevant interested parties and their requirements relevant to

Renco’s QMS, in order to prevent potential effect on our ability to consistently provide

products and services which meet the customer and applicable legal requirements, Renco will

keep on monitoring and reviewing their requirements.

Interested Parties

The need and expectations Monitoring/Reviewing (Who/When)

Customers Good quality, On‐time delivery, quick response and support, timely notice of ECR/ECN, and Low Cost

Customer survey, RMA Tracking, monitor customer complaints

External Providers

Payment as agreed, partner relationship, clear and adequate requirement for RFQ and PO, marketing

On time delivery and quality reporting

Legal Body RoHS, REACH, Conflict Mineral Certification, declaration

Employees Professional development, employment security, good working relationships and environment

Turnover rate

Bank Good Financial credit, good inventory control Excellent credit rating, high inventory turn.

4.3 Determining the scope of the quality management system

Scope: FRM‐MR‐02

Location: Quality Manual

4.4 Quality management system and its processes

QSP‐MR‐02 establish, implement, maintain and continually improve this QMS. The below

figure shows the processes needed and their sequence and interactions, and Renco will:

a) Determine the inputs required and the outputs expected from these processes;

b) Determine and apply the criteria and methods needed to ensure the effectiveness of the

processes;

c) Determine the resources needed for these processes and ensure their availability;

d) Assign the responsibilities and authorities for these processes;

e) Address the risks and opportunities as determined in accordance with the requirements of

section 6.1

f) Evaluate these processes and implement any changes needed to ensure achieving their

intended results;

g) Improve the processes and the quality management system by matrix / quality objectives


5. Leadership 5.1 Leadership and commitment


5.1.1 General

Top management shall demonstrate leadership and commitment with respect to the QMS by:

5.2 Policy

5.2.1 Establishing the quality policy

Top management establish, implement and maintain the quality policy as below:

Total Customer satisfaction through meeting customers and applicable statutory requirements,

and pursuing continual improvement of provided products and service.

5.2.2 Communicating the quality policy

The quality policy is posted in the office, throughout the facility, and communicated within

organization by handing a card to everyone. All employees shall understand and apply the quality

policy during the daily operation.

5.3 Organizational roles, responsibilities ad authorities

Top Management assign the Quality Manager the responsibility and authorities to:

Ensure the QMS conforms to the requirements of ISO9001:2015;

Ensure the processes are delivering their intended outputs;

Report the performance of QMS and the opportunities for improvement to top management;

Ensure the promotion of customer focus throughout the organization;

Ensure the integrity of the QMS when change to the QMS is planned and implemented.


The responsibilities and authorities for relevant roles/functions is assigned as below:


6. Planning 6.1 Actions to address risks and opportunities

After considering the external & internal issues (4.1) and the requirements of interested parties

(4.2) of FRM‐MR‐02, We determine the below risks & opportunities need to be addressed to assure

the intended results of QMS, and enhance desired effects, and prevent/reduce undesired effects,

and achieve improvement. We also plan the actions to address these risks and Opportunities (see

the below), and those actions shall be integrated and implemented into Renco QMS, and shall be

proportionate to the potential impact on the conformity of product and services.

We shall evaluate the effectiveness of those actions to Risks and Opportunities at least annually.

Interested Parties

Risks & Opportunities need to be addressed

S P Actions to address these Risks & Opportunities

Effectiveness Of actions

Customers Customer doesn’t/Can’t Pay Business Loss due to quality issue Business loss due to cost down OTD issue during Chinese New Year Gain new customer globally

H H H M

L L L L

M M M M‐L

Customer credit limit need approval Inspect shipment for major product Share the cost down with factory Arrange the shipment in advance

External Providers

Cost up from factory Delivered parts don’t meet spec Lead time can’t meet promise Misunderstand the requirement Unaware of factory change

MH MMH

ML L L L

M M‐L M‐L M M

Share increased cost with customer Inspect shipment for major product Communicate with factory/cust Show clear info on spec Visit/Audit key factories annually

Legal Body Fail to meet RoHS, REACH, CRMT H L M Collect data from supply chain

Employees Pass wrong info to customer or factory Human error in daily operation Leave the position/company

H MM

L L L

M M‐L M‐L

Improve awareness Quality/risks Improve ERP error‐proof function Manage the Organization knowledge

Bank Can’t get the loan when needed H L M Keep excellent company credit

Others Instable currency rate Uncertain Tariffs policy Loss of electric power

H MM

MMM

M‐H M M‐L

Fix the currency rate for PO to factory Observe and communicate with cust Ensure back‐up power generator

Note: S – Severity; P‐Possibility; H – High; M – Medium; L – Low; M‐L – Medium to low; M‐H – Medium to High

6.2 Quality objectives and planning to achieve them

Top Management and Quality leaders establish company level quality objectives to support the

quality policy, and establish function level quality objectives to support the company quality

objectives. Executive task board and Renco Goals and Objectives, will list company objectives.

6.3 Planning of changes

Renco will control the change to QMS in a planned manner by considering:

a) The purpose of the changes and their potential consequences;

b) The integrity of the QMS;

c) The availability of resources;

d) The allocation of reallocation of responsibilities and authorities


7. Support 7.1 Resources

7.1.1 General

QSP‐MR‐01, Top Management determine and provide the resources needed for the QMS, and we

consider;

a) The capability of, and constraints on existing internal resources;

b) What needs to be obtained from external providers?

7.1.2 People

QSP‐MR‐01, Top Management determine and provide the persons necessary for the QMS, refer to

5.3 – Role Responsibility

7.1.3 Infrastructure

QSP‐MFG‐01, Manufacturing Manager determine, provide and maintain the infrastructure

necessary for the operation of its processes and to achieve conformity of products, including

building, warehouse equipment, computer, telecommunications, ERP system, and so on.

7.1.4 Environment for the operation of processes

QSP‐QA‐05, Manufacturing and Maintenance determine, provide and maintain the environment

necessary for the operation of its processes and to achieve conformity of products and services,

including:

a) Non‐discriminatory, calm, non‐confrontational;

b) Stress‐reducing, burnout prevention;

c) Comfortable temperature, humidity, light, airflow, hygiene to employee;

d) Suitable temperature (≤ 80 ⁰F) and humidity (≤ 60 % RH) to warehouse for protection of products

7.1.5 Monitoring and measuring resources

All measuring and test equipment which could affect the quality of the finished products will be

calibrated by an external sub‐contractor in accordance with ISO 100012.

Renco will also ensure that:

Personnel will select appropriate equipment for the measurement to be made

All of this equipment and standards will be identified and calibrated

Records of details of equipment, identification number, location, checking frequency and method, tolerances and what to do when equipment is out of specification

Records of calibration will be maintained with NIST traceable certificates

Our procedures will explain what to do with previous results when equipment is found out of calibration

Our equipment will be handled, cleaned, maintained and stored accordingly.

Adjustments to equipment will be controlled


A list of all equipment shall be maintained within the computer system. Any calibration result that

indicates that product may be nonconforming, will require Quality Control to investigate the

inspection/test and determine if it needs to be repeated. Gauges are recorded in the computer and

will be recalled by the Quality Manager within a month of the due date. All responsibilities have been

defined within the procedures for the control of the above referenced tools.

Procedures Reference: QSP‐QA‐03 Calibration

QSP‐QA‐05 Preventative Maintenance

7.1.6 Organizational knowledge

QSP‐MR‐03 determine the knowledge necessary for the operation of its processes and to achieve

conformity of products and services. This will include a collection of attendees and meeting

minutes from all meetings. Organizational knowledge will be maintained at Z:\_Company ‐

Public\Organizational Knowledge, in the computer system. When addressing changing needs and

trends, Engineering Manager and Quality Manager shall consider our current knowledge and

determine how to acquire or access any necessary additional knowledge and required updates.

*NOTE: Organizational knowledge can be based on:

a) Internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned

from failures and successful projects; capturing and sharing undocumented knowledge and

experience; the results of improvements in processes, products and services);

b) External sources (e.g. standards; academia; conferences; gathering knowledge from customers or

external providers)

7.2 Competence

QSP‐TR‐01, QSP‐MFG‐01 determine the necessary competence of person(s) doing work under our

control that affects the performance and effectiveness of the quality management system;

(Manufacturing Manager and Quality Manager)

Human Resources Coordinator ensure these persons are competent on the basis of appropriate

education, training, or experience; and where applicable, we will take actions to acquire the

necessary competence, and evaluate the effectiveness of the actions taken; and we retain

appropriate documented information as evidence of competence.

7.3 Awareness

The Human Resources Coordinator, department leads and Quality Manager ensure that persons

doing work under the organization’s control are aware of:

a) The quality policy;

b) Relevant quality objectives;

c) Their contributions to the effectiveness of the QMS, including the benefits of improved

performance;

d) The implications of not conforming to the quality management system requirements


7.4 Communication

The Quality Manager determines the internal and external communications relevant to the QMS:

An RFQ is received & quote is prepared for the Customer

REF: QSP-SAL-03

An order is received & entered into the ERP system

REF: QSP-SAL-03

The “Sample Request” is entered into the system

REF: QSP-SAL-02

Is it a Sample Request?

Engineering develops a “Design Paper Work” for

all new products

Any changes to product will be documented, reviewed & implemented using an ECN

YES

Custom or Standard Custo

NO

Materials are purchased

REF: QSP-PUR-01

Standard

Materials are purchased

REF: QSP-PUR-01

Is there any RMA’s

YES

All RMA’s will be handled by Quality

REF: QSP-QC-02

NO

END

START Appendix I


Cont: from last PG

Materials are inspected

REF: QSP-QC-05

Is there any

NO

YES

NC materials will be documented, reviewed &

disposed of

Any NC’s requiring further action either product, internal, supplier or customer will have a CAR issued

REF: QSP-CA-01

All CAR’s will be reviewed as part of the on-going Internal

Audit program

Manufacturing schedules & complete production in accordance with the

“Job Package”

New

NO

Prototype testing is carried out by

QC

1st Article Inspections are

completed

All products are inspected & tested to

an AQL by QC

Product is packaged & shipped to the

customer in accordance with the

Shop Order REF: QSP-SHP-01

1st Piece or Prototype YES

1st Piece Prototype

END

END

Appendix I


7.5 Documented information

7.5.1 General

Renco’s ISO9001:2015 QMS include,

a) Documented information required by ISO9001:2015;

b) Documented information determined by Renco as being necessary to the effectiveness of the

QMS.

7.5.2 Creating and updating

QSP‐DOC‐04. When creating and updating documented information, Quality Manager ensue

appropriate:

a) Identification and description (e.g. a title, date, author);

b) Format (e.g. language, software version, graphics) and media (e.g. paper, electronic);

c) Review and approval for suitability and adequacy

7.5.3 Control of documented information

Quality Manager and Document Controller will control the documented information required by

ISO9001 standard and QMS to ensure;

a) It is available and suitable for use, where and when it is needed;

b) It is adequately protected

7.5.3.2 QSP‐DOC‐04 address the following activities for the control of documented information, as

applicable:

a) Distribution, access, retrieval and use;

b) Storage and preservation, including preservation of legibility

c) Control of changes

d) Retention and disposition

QSP‐QC‐06 identify the external document needed for QMS, and control them.

8. Support 8.1 Operational Planning and control

Engineering and Sales plan, implement and control the processes (see 4.4) needed to meet the

requirements for the provision of products and services, and to implement the actions determined

in planning phase, by:

a) Determining the requirements for the products;

b) Establishing criteria for:

1) The processes;

2) The acceptance of product

c) Determining the resources needed to achieve conformity to the product and service

requirements;


d) Implementing control of the processes in accordance with the criteria;

e) Determining, maintaining and retaining documented information to the extent necessary:

1) To have confidence that the processes have been carried out as planned;

2) To demonstrate the conformity of products and services to their requirements. We

assure the output of our planning is suitable for our operations.

QSP‐DOC‐02 will control planned changes and review the consequences of unintended changes,

and take action to mitigate any adverse effects, as necessary.

8.2 Requirements for products and services

8.2.1 Customer Communication

Communication between Renco and its customers is to ensure that any updates, amendments,

additions, Etc., are handled effectively. This will include also any customer complaints, feedback

and product requirements.

Any contractual amendments are also subject to contract review.

Reference Procedures: QSP‐SAL‐01 Request for quote

QSP‐SAL‐02 Sample Requests

QSP‐SAL‐03 Receipt of an order

8.2.2 Determining the requirements for products and services

As part of our RFQ/Order process, Renco will determine the requirements needed to fulfill the

customers order. These requirements will include:

Delivery times

Specifications/Documentation

Regulatory and legal requirements are identified, such as traceable clauses

Inspection method selection

Sequence of operations

8.2.3 Review of the requirements for products and services

To ensure that our customer’s products are on time, traceable and meet or exceed the quality they

expect from Renco. All orders, quotations, and inquires will be reviewed by Renco to ensure that:

Customers requirements are unambiguous, clearly defined and documented

Changes to requirements are resolved with the customer, documented and communicated

to all persons affected by the change

We can meet customer requirements and mandated specifications

Any risks associated with new techniques, new items which have not been manufactured

previously, or short lead times, are evaluated

The records produced will be kept and maintained in accordance with 8.2.3.2


8.2.4 Changes to requirements for products and services

Engineering and/or Sales ensure that relevant documented information is amended, and that

relevant persons are made aware of the changed requirements, when the requirements for

products and services are changed.

8.3 Design and development of products and services

8.3.2 Planning

The design of a product is the result of thorough and careful consideration of the customer’s

requirements, the potential use of the product, the potential product life cycle and the

manufacturability of the product.

When appropriate, timely project plans are prepared by engineering that identify the responsibility,

budgets, staffing and schedules for each design and development activity. The plans are updated

and communicated to the appropriate individuals as each design evolves. The plan describes or

references the following activities:

Review of product specifications for accuracy and completeness

Identification of the various design and development stages

Outline and timing of design reviews

Determine the verification and validation appropriate to each design and development stage

Organizational and technical interfaces between different groups (internal and external) are identified and the necessary information documented, transmitted, and reviewed

Determine project roles and responsibilities

Plan and schedule regulatory testing as required

8.3.3 D&D Inputs

Design input requirements relating to the product requirements are identified, documented and

reviewed for adequacy. Requirements are to be complete, and not in conflict with each other.

Records of design input requirements are maintained as per control of records. Design inputs

consider, but are not limited to:

Requirements established by the customer

Functional and performance requirements

Design constraints


Requirements for certification / agency approvals

Performance characteristics such as environmental and usage conditions, including any reliability requirements

Industry standards, safety and regulatory requirements

Packaging and marking

Quality / product assurance inspection activities

Verification and validation testing requirements

Application requirements

Manufacturing and procurement requirements

Analysis of similar product (previous similar design) and process designs, work operations, deviations, quality records, RMA reports, and customer complaints to detect and eliminate potential causes of non‐conforming products

Manufacturability of design

Establish targets for product quality, life, reliability, durability, maintainability, timing and cost

8.3.4 D&D Controls

Verification is confirmed through the provision of objective evidence of the following:

Comparison of designed product to the product input requirements as defined by 8.3.3

Evaluation of product against similar designs or against competitions products as appropriate: Testing to ensure compliance with product input requirements as defined by 8.3.3. These tests consider electrical and environmental stresses at least as severe as the design objectives. Full review of documentation with respect to product input requirements and to any verification

test results prior to issue.

Validation is confirmed through the provision of objective evidence of the following:

The requirements for a specific intended use or application, where known, have been fulfilled

Validation is completed, where practicable, prior to the delivery or implementation of the product

Maintain records of the results of validation or other necessary actions

Engineering prototypes are subject to the validation per planned arrangements 8.3.2 Validation of manufacturing process

8.3.5 D&D Outputs

The design outputs are documented in a form that enables the verification against the design

and development inputs. Design outputs include, but are not limited to:

Meeting the design input requirements including customer specific requirements

Provide appropriate information required for manufacturing of the product

Reference or contain product acceptance criteria

Conform to documented industry, safety and regulatory requirements where appropriate: o Identify the characteristics of the product that are essential to the safe and proper use

and handling of the product o Identify appropriate manufacturing testing requirements o Provide a method for recording manufacturing test results


8.3.6 D&D Changes

All design changes are identified, documented, reviewed and approved by authorized personnel before implementation

Records of changes during the development process are maintained

Engineering and Quality Assurance are responsible for monitoring and ensuring that the changes do not adversely affect product quality, performance, or reliability

Review of the changes include evaluation of the effect of the changes on the components and product already delivered

Customers are notified of design changes affecting the form, fit, or function of a product. In addition, and where contracted or mandated by contract, customer approval of design changes is obtained

Reference Procedure: QSP‐ENG‐01 Prototype Engineering QSP‐ENG‐06 Component Part Numbers and Revision Levels

8.4 Control of externally provided processes, products and services

8.4.1 General

QSP‐PUR‐02 Quality Manager and Purchasing Manager ensure that externally provided

processes, products, and services conform to requirements.

Quality and Purchasing determine controls to be applied to external providers.

Quality and Purchasing determine and apply below process/criteria for the evaluation, selection,

monitoring or performance, and re‐evaluation of external providers, based on their ability to

provide processes or products and services.

Process 1: Selecting and evaluating external provider. Owner: PM/QA/Act

Process 2: Monitoring and re‐evaluation of external provider Owner: QA/PM

Purchasing leadership will retain documented information related to suppliers.

8.4.2 Type and extent of control

Quality Manager ensure that externally provided processes, products and services do not adversely

affect our ability to consistently deliver conforming products and services to our customers.

Purchasing Manager ensure that externally provided processes remain within the control of its

QMS; QSP‐PUR‐02 define how to control the external provider and the resulting output from the

external provider, including the verification to ensure the externally provided processes, products &

services meet requirements.


8.4.3 Information for external providers

Purchasing, Sales, Engineering personnel ensure the adequacy of requirements prior to their

communication to the external provider. Purchasing will communicate to external providers its

requirements for:

a) The processes, products and services to be provided;

b) The approval of products & services / Methods, processes & equipment / release of products &

services.

c) Competence (including any required qualification of persons) and the interactions with Renco;

d) Control and monitoring of the external providers’ performance to be applied by the organization;

e) Verification/validation activities Renco/customer intends to perform at the external providers

premises

8.5 Production and service provision

8.5.1 Control of production and service provision

Renco will implement production and service provisions under controlled conditions.

The production and design operations at Renco are controlled to ensure that the following

requirements are met:

Technical data is available to verify the parts being manufactured

Procedures have been documented for all processes where required.

Measuring instruments and test equipment are used as required to verify product

Monitoring of manufacturing processes

Key characteristics identified by the design are monitored (These will be recorded in the “Final Inspection Sheets” and “First Article Sheets”)

Any utilities which can affect the quality of the product are controlled

All jobs are completed using the job package documentation attached to the Shop Order. This may include drawings and inspection plans as required

8.5.2 Identification and traceability

QSP‐QA‐07. Renco will identify all parts during all stages of receipt, manufacturing, inspection,

packaging and shipping for traceability and its inspection status of PASS, FAIL or ON‐HOLD. All

materials purchased will be traceable back to their source of supply if required by the customer. For

example, by using a C of C.

All goods received into Renco will be identified as to their inspection status by using accompanying

paperwork. This is done at each stage of the “Traveler”. The responsibility for identifying the

inspection status will be recorded with an inspector’s stamp or signature and date.

If the customer requires by contract, regulatory or other established requirement that the materials

be traceable then Renco shall provide the following as applicable:

Identification of parts throughout the life of the product with permanent stamps

Any batch traceability requirements, including scrap will be traceable back to the material lot number


The inspection records shall also identify who is responsible and authorized to verify, certify and

release the products. This will be indicated by an authorized signature, or an assigned stamp which

is controlled internally.

8.5.3 Property belonging to customers or external providers

QSP‐QA‐08. Renco will handle all customer property with responsibility and care.

8.5.4 Preservation

QSP‐MAT‐05 preserve the products to ensure conformity to requirements, including:

Request factory to use suitable packaging to prevent damage during transit

Control temperature and climate in the warehouse to protect stored product

8.5.5 Post‐delivery activities

Renco will provide post‐delivery service associated with the products and services, including:

a) Applicable RoHS, REACH, Conflict minerals declaration

b) Engineering or application support, when it is requested from key customers

c) Customer feedback, including RMA, quality complaints

d) Others

8.5.6 Control of changes

QSP‐MFG‐01, QSP‐DOC‐02 review and control changes for production, to the extent necessary t

ensure continuing conformity with requirements. Refer to 8.2.4 Changes to requirements for

products and service.

Engineering and Manufacturing retain documented information describing the results of review of

changes, the person(s) authorizing the change, and nay necessary actions arising from the review in

ERP system.

8.6 Release of products and services

QSP‐QC‐04 Renco implement planned arrangements, to verify that the product requirements have

been met. The release of products to the customer shall not proceed until the planned

arrangements have been satisfactorily completed, unless otherwise approved by the customer or

top management/QA Manager.

All documented information related to product conformity, will be retained by QA on FRM‐QC‐04

8.7 Control of nonconforming outputs

QSP‐QA‐04 ensures nonconformances are identified and controlled to prevent the unintended use

or delivery. Quality and Manufacturing will take appropriate action based on the nature of the


nonconformity and its effect. Nonconforming outputs can be handled in one or more of the

following ways:

a) Rework/correction

b) Segregation, containment, return or suspension of provision of products

c) Informing the customer

d) Obtaining authorization for acceptance under concession

Conformity to the requirements shall be verified when nonconforming outputs are reworked or

corrected.

8.7.2 Quality Control will retain documented information that:

a) Describes the nonconformity;

b) Describes the actions taken;

c) Describes any concessions obtained;

d) Identifies the authority deciding the action in respect to the nonconformity

9. Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation

Renco has determined the following conditions for monitoring, measurement, analysis and

evaluation activities:

Top Management will retain appropriate documented information as evidence of these results –

Data Analysis

9.1.2 Customer Satisfaction

For the important customers, we will conduct the customer satisfaction survey annually. Top

Management and Quality Manager will retain the information.

9.1.3 Analysis and evaluation

Analyze and evaluate appropriate data and information arising from monitoring and measurement.

The results of analysis shall be used to evaluate the below.

a) Conformity of products;

b) The degree of customer satisfaction;

c) The performance and effectiveness of the QMS;


d) If planning has been implemented effectively;

e) The effectiveness of actions taken to address risks and opportunities;

f) The performance of external providers

g) The need for improvement to the QMS

*Note: The results of above analysis shall be shown during management review

9.2 Internal audit

QSP‐QA‐02 Internal audits will be performed once a year to confirm the effectiveness of the QMS.

To verify the effectiveness of our quality system and implement any improvements, Renco has

documented procedures to ensure:

Audits will be carried out against procedures and a schedule

The schedule has also been set based on importance of areas to be audited

Follow up action and the results of these audits will be documented and reported

Records will be maintained of the audits in accordance with section document control

All auditors have been trained and will be selected independent of the area to be audited

9.3 Management review

Top Management officially reviews the QMS yearly to ensure its continuing suitability, adequacy,

effectiveness, and alignment with the strategic direction of Renco.

9.3.1 Management review inputs

Inputs have been identified as part of our set agenda for the Management Review. These inputs

include:

Internal and external audit results

Corrective and preventive actions

Non‐Conforming products and processes

Customer feedback

Follow‐up actions from previous meetings

Changes that need to be reviewed and planned for

Recommendations for improvement

9.3.2 Management review outputs

The output of the management review meeting will be recorded in the form of minutes and a list of

action items. The list if action items will show:

Any areas of system/process improvements

Researching of new processes and equipment to meet customer requirements

Resource needs, objectives and policy changes

Responsible personnel and target completion dates

Reference Procedure: QSP‐MR‐01 Management Review


10. Improvement

10.1 General

Renco determines and selects opportunities for improvement and implement any necessary actions

to meet customer requirements and enhance customer satisfaction, these shall include:

a) Improving products to meet requirements as well as the address future needs and expectations

b) Correcting, preventing or reducing undesired effects;

c) Improving the performance and effectiveness of the QMS

10.2 Nonconformity and corrective action

10.2.1 Renco will take the appropriate actions to eliminate the cause of nonconformities in order to

prevent reoccurrence. Corrective actions are appropriate to the effects of the nonconformity

encountered. The process requirements will include:

Reviewing nonconformities

Determining the cause of nonconformities

Evaluating the need for action to ensure that non‐conformances do not recur

Determining and implementing action needed

Records of the results of action taken, per control of documents

Reviewing the corrective action taken

Reference Procedure: QSP‐QA‐01 Corrective & Preventive Actions

Note: Corrective actions shall be appropriate to the effect of the nonconformities encountered

10.2.2 QSP‐QA‐01 and QSP‐QA‐04 will retain documented information in ERP system. Information

to be kept is, but not limited to:

a) The nature of the nonconformities and any subsequent actions taken;

b) The results of any corrective action


10.3 Continual Improvement

Renco will continually improve the effectiveness of the quality management system though the

quality policy, quality objectives, audit results, analysis of data, corrective and preventative action,

and management review. Procedural changes will have a “change log” attached to the associated

procedure.

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Renco Electronics, Inc. Quality Manual · 2019. 12. 19. · Proprietary Material of Renco...

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