supplier quality requirements manual...the supplier quality requirements manual represents a...

SUPPLIER

QUALITY REQUIREMENTS

MANUAL

Ref: FDA: Code of Federal Regulations (CFR), 21, Part 820

Health Canada: Canadian Medical Devices Regulations (CMDR)

American Society of Mechanical Engineers (ASME): Boiler & Pressure Vessels Code

International Standards:

ISO 9001:2008, ISO 13485:2003, 2010/35/EU Transportable

Pressure Equipment Directive (TPED)

QUALITY POLICY STATEMENT

We are committed to continually improving ourselves, our products and services, and our systems,

processes, and practices in order to comply with requirements and provide to our customers a peace-of-

mind that only comes from setting and effectively maintaining high safety, reliability, and quality

standards.

Revision H 8/23/17 Page 1 of 15

SHERWOOD SUPPLIER QUALITY REQUIREMENTS MANUAL

TABLE OF CONTENTS

1.0 Introduction

2.0 Goals and Objectives

2.1 Sherwood’s Goal

2.2 Objective for Supplier Quality

3.0 Supplier Requirements

3.1 General Compliance

3.1.1 Sherwood

3.1.2 Regulatory

3.1.2.1 REACH

3.1.2.2 RoHS

3.1.2.3 Conflict of Minerals

3.2 Supplier Selection

3.2.1 Part Qualification

3.2.2 Supplier Corrective Action Request

3.2.3 Supplier Re-evaluation

3.3 Supplier/subcontractor’s Quality System

3.4 Supplier Responsibility

3.4.1 Quality Planning

3.4.2 Critical Characteristics

3.4.3 First Article Inspection

3.4.4 Deviation Request

3.4.5 Training

3.4.6 Records

4.0 Assurance Of Product and Process Quality

4.1 Source Inspection

4.2 Design/Process Change Control

4.3 Manufacturing Control

4.4 Nonconforming Material

5.0 Documentation Of Process Quality

5.1 Internal Quality System Audit

5.2 Quality Improvement Action System

5.3 Calibration/Maintenance of Gages

6.0 Supplier Evaluation

6.1 Supplier Development

6.2 Performance Monitoring


6.3 Disqualification

6.4 Current Suppliers

7.0 Cost Reduction Activities

8.0 Rewards

9.0 Supplier Traceability

10.0 Appendix

10.1 Candidate Supplier/Subcontractor Quality Evaluation Report

10.2 Supplier Quality System Self Assessment Questionnaire

10.3 Supplier Certificate Agreement

10.4 Supplier Parts Certification List

10.5 Supplier Corrective Action Requests

10.6 Supplier Performance Report

10.7 Certification of REACH Compliance

10.8 Certification of RoHS Compliance

10.9 Conflict Minerals Questionnaire and Certification


1.0 Introduction

The employees at Sherwood would like to thank all of our suppliers for assisting us in reaching our sales goals

and staying in keeping with our quality policy. Growth in our industry would not be possible without your

efforts.

Our mutual success depends upon our ability to meet an increasingly competitive market. Therefore, it is

imperative that we seek a new level of performance.

The Supplier Quality Requirements Manual represents a strategy for partnership in continued growth, cost

reduction, productivity, market penetration and profitability through quality.

This Supplier Quality Requirements Manual is intended to provide valued suppliers and potential new suppliers

with the basis for understanding the quality expectations of Sherwood.

The Manual establishes the minimum quality requirements for all suppliers and sub-contractors of production,

service materials, finished devices whether the products, services or finished devices being furnished are

provided by the supplier directly or are purchased from sub-contractors for use in Sherwood products.

These quality requirements are a supplement to and do not replace or alter other terms and conditions covered

by Purchasing Documents, Specified Warranty Agreements and requirements of Engineering Drawings,

Specifications or Contract conditions.

2.0 Goals and Objectives

2.1 Sherwood’s Goal

Sherwood’s goal is continued growth in our current markets and expansion into new markets worldwide. This

requires that we provide quality products and services that fulfill our customer expectations the first time, every

time.

2.2 Objective for Supplier Quality

To define and communicate Sherwood’s Quality Policy and expectations to our suppliers and subcontractors.

To understand and comply with these requirements is an important building block toward achieving a long-term

partnership that shall enable us as a team to fulfill our customers’ expectations.

Our objective is to consider our suppliers as an extension of our manufacturing operations. Underlying this

relationship is a mutual commitment to assure that design, process quality, delivery and cost requirements are

completely defined and agreed to prior to production. There shall be an understanding of this commitment by

each function within the organization.

Conformance to all policies and procedures outlined in this manual

Innovation

Quality and Reliability levels are established and improved on a continuous basis

100% conformance to specifications

Process Control and Pre-Control

100% on-time delivery

Assure that Sherwood specifications and requirements are clearly defined

Reduce incoming inspection through supplier certification

Cost containment and reduction programs

3.0 Supplier Requirements

3.1 General Compliance

3.1.1 Sherwood’s Requirements

Sherwood requires product to adhere to the guidelines of PUR-207 Purchased Components Requirements. It

is the supplier/subcontractor’s responsibility to have systems and controls to ensure this defect-free requirement.

http://www.sherwoodvalve.com/assets/base/doc/PUR207.pdf


3.1.2 Regulatory Requirements

Sherwood must comply with national and international laws and regulations. Therefore, we may require our

supplier/subcontractors comply with them as well.

Some regulations require a complete flow of certain information along the supply chain. Vendors may receive

periodic requests from Sherwood for this information. The following are typical:

3.1.2.1 Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)

European requirement on the restriction of chemicals that are characterized as Substances of Very High

Concern (SVHC) that are identified as having risks associated with the human health and the environment,

promotion of non-animal testing, and maintenance and competitiveness of the EU chemical industry. There are

two lists to be aware:

a) SVHC Authorization List

b) SVHC Candidate List

The first list is referenced in the Directive and required by law to begin removing these substances from

products by a certain date. The second list are chemicals that are being evaluated to determine if they will be

added to the authorized list.

Suppliers are required to provide information regarding both lists. At a minimum, the name of the substance has

to be communicated.

Sherwood will send suppliers SQCF-4126 Certification of REACH Compliance (appendix 10.7) to obtain

supplier certifications that the material meets the requirements.

3.1.2.2 Restriction of Hazardous Substances Directive (RoHS)

European requirement restricting the use of certain hazardous substances in electrical and electronic equipment.

It targets the reduction of six substances to protect the environment: lead, mercury, cadmium, hexavalent

chromium, Polybrominated biphenyl, and Polybrominated diphenyl ether.

Sherwood will send suppliers SQCF-4127 Certification of RoHS Compliance (appendix 10.8) to obtain supplier

certifications that the material meets the requirements.

3.1.2.3 Conflict of Minerals

The US Securities and Exchange Commission (SEC) regulations require identification of products that contain

tin, tantalum, tungsten, or gold that originate from the Congo and surrounding areas.

Minerals may come from these areas, however, there are certain rules and regulations on how business is

conducted to ensure that monies made are not contributing to the sale of arms for guerrilla warfare.

Sherwood will send suppliers SQCF-4128 Conflict Minerals Questionnaire and Certification (appendix 10.9) to

obtain supplier certifications that their material meets the requirements.

3.2 Supplier Selection

Purchasing, Engineering, Quality Assurance (QA), and Manufacturing Engineering may initiate the

supplier/subcontractor selection process by collecting the appropriate business information (prices, company

history, references) about the potential supplier.

Potential Suppliers will be placed into two categories. The first category is any supplier that provides a

component or a service that directly effects the quality of the finished product. These suppliers are required to

complete form SQCF-1050 Supplier Quality Self-Assessment Questionnaire. Upon completion of the

assessment, an on-site evaluation of the supplier/subcontractor’s facility may be conducted as determined by

Quality. Reasons for an on-site evaluation may include that the results of the Self-Assessment were insufficient

or the component/service that is being provided has been identified as critical. In the case that an on-site

evaluation is necessary, form SQCF-4012 Candidate Supplier/Subcontractor Quality Evaluation Report will

need to be completed by the Sherwood Quality Team. The second category is any supplier that provides a

component or service that does not directly effect the quality of the finished product. Suppliers that fall into this

category will not need to complete a self-assessment evaluation.


It is the supplier/subcontractor’s responsibility to evaluate its quality system, complete and score evaluation

report. The supplier shall return evaluation report to Sherwood’s Quality Department for review within ten

business days. The report shall be evaluated and the results reviewed with the supplier, where appropriate.

After completion of the assessments, the supplier shall be informed of the results. When corrective action is to

be taken, the supplier is responsible for developing the corrective action plan including completion dates within

ten business days.

When the supplier evaluation process is complete the Supplier Quality Self-Assessment Questionnaire form is

marked appropriately and placed in the vendor files in the QA department.

3.2.1 Part Qualification

Purpose:

To identify requirements a supplier must meet when submitting a part for Sherwood’s approval not previously

purchased from that supplier.

The selected supplier must be able to continuously demonstrate the capability of sustaining a quality and

manufacturing system conducive to that of good business, manufacturing, and quality practices. Part

qualification will aid in ensuring that the supplier has a sound quality system and the ability to consistently

produce parts which conform to purchase order requirements and specifications.

In order for the Supplier to have their parts qualified, they must follow the Procedure laid out in SQR-2.0

Supplier Sample Submission Procedure. A cross functional team of Engineering, Quality and Production will

decide which Guidelines under Procedure – 1. Sample Submission Guidelines are required for qualification.

Once the supplier receives first piece approval, Sherwood’s Quality, Manufacturing Engineering and Design

Engineering may develop a part qualification plan. This plan will include the requirements and acceptance

criteria to be met once First Piece Approval has been attained. If additional quantities of the component are

required to complete the qualification testing, the supplier will be notified. The results of this qualification test

will be appended to SQCF 1005 Supplier Sample Submission and reported to the supplier. Release for

production quantities is dependent upon successful completion of all requirements of this document.

3.2.2 Supplier Corrective Action Request

Supplier Corrective Action Requests are primarily initiated by Quality or Material Review Board (MRB).

Supplier corrective actions may be requested for: nonconforming deliveries or any other quality or safety

related issues resulting from supplier/subcontractor performance.

Quality has the primary responsibility to notify the supplier of discrepant material, obtain the necessary return

authorization number and initiate the return of the discrepant product. SQCF-4016 Supplier Corrective Action

Request, a.k.a. SCAR, (appendix 10.5) shall be sent in any type of medium.

The supplier/subcontractor is responsible for submitting an interim response (containment) to Sherwood within

48 hours of receiving the corrective action request. This response is to acknowledge receipt of the request and to

communicate disposition/containment activities of suspect product.

The supplier/subcontractor is responsible to investigate the cause for the nonconformance, defect or

discrepancy, document the root cause and the corrective action taken, implement corrective action and return

the completed report to Quality for review and approval within 14 days of the issuance date. An approved

response is entered into the MVR database and a hard copy is attached to the master. A hard copy of vendor

response will be filed in Quality. A vendor may choose to respond via fax, e-mail or mail. Phone responses

will be documented and followed up with a hard copy. The supplier/subcontractor may request for an extension

if they need more information or time to provide a proper root cause and corrective action.

Quality will review the returned corrective action response for disposition of supplier action depending on

whether the supplier/subcontractor’s response has satisfied the following conditions:

The actual cause of the nonconformance is identified.

The corrective action initiated will prevent recurrence.

The affectivity is defined, i.e., the date, lot or serial number.


If the Supplier Corrective Action Report response is not approved, Quality notifies the supplier/subcontractor to

investigate further action. The supplier/subcontractor is requested to submit a revised corrective action to

Quality within ten business days. The supplier/subcontractor may request additional time for Corrective Action

Request response.

Quality will monitor any unanswered requests, for supplier follow up. If a response has not been received

within the allotted timeframe, Quality will contact the vendor for status.

If the supplier does not respond to the corrective action request, Quality may schedule a meeting with the

supplier or a visit to the supplier/subcontractor’s facility.

NOTE: In cases where the supplier does not respond to a corrective action request or the corrective action is

disapproved, Quality and Purchasing will take the action deemed necessary to prevent further procurement. This

may negate the supplier’s approval status.

Proposed corrective action responses are considered delinquent if they are not submitted within the specified

time allotment and additional time was not requested and approved. Resolutions for supplier or subcontractor’s

delinquent corrective action responses or responses that have been rejected twice are discussed by the MRB.

Resolution may negate the supplier’s approval status.

The approved supplier/subcontractor’s corrective action response is filed in the Quality Department. Quality is

responsible to determine if verification of the supplier’s corrective action is required. If verification is not

required, the supplier corrective action is closed out.

If verification is required, Quality verifies the effectiveness of the supplier/subcontractor corrective action and

the verification date is documented on the SCAR. Verification activities can include but are not limited to:

supplier audits, subsequent component lot acceptance, and supplier documentation.

If the supplier’s corrective action is deemed effective it is closed out and filed. The Quality personnel’s

signature and date is required on the closed SCAR indicating the document was reviewed and the results are

acceptable.

If the supplier/subcontractor’s corrective action is not effective, Quality will reissue or issue another SCAR.

The status of SCARs is monitored by Quality in the Nonconformance / Corrective Action Log on the computer

system database.

3.2.3 Supplier Re-evaluation

Quality and Purchasing shall conduct periodic reviews of the current supplier base per section 6.0 Supplier

Evaluation. The review shall be based upon risk, performance and volume. Supplier re-evaluations may also

include, per Sherwood’s discretion, on-site audits or supplier completion of SQCF-4012 Sherwood Supplier

Quality Evaluation Report, Appendix 10.1.

Results from the supplier re-evaluations will be reviewed by the Quality and Purchasing Departments to

determine if continued procurement will be granted.

3.3 Supplier/Subcontractor’s Quality System

When determined by Sherwood Quality, the supplier shall establish and maintain a documented quality system

as a means of ensuring that the product conforms to specified Sherwood requirements.

The supplier shall be requested to submit a copy of their quality manual or a written description of their quality

system for review by Sherwood’s Quality Department.

Sherwood’s Quality Department does reserve the right to determine that only a portion of the requirements may

be applicable to particular suppliers/subcontractors.

The following is an outline or an example of components that should be included in a quality system:

Minimum Quality System Requirements

I. Company/Facility Quality Policy Statement

II. Quality Manual

III. Organizational Chart (specifically Quality reporting lines)


IV. Incoming Material

A. Certification requirements-raw and component material.

B. Material verification requirements and procedures relating to supplied material-in-house

and/or outside laboratory.

C. Inspection procedures including sample selection plans (as applicable).

D. Documentation format and requirements (methods).

E. Accept/reject material identification policy and procedures.

V. In-Process

A. Set-up inspection, including personnel responsibilities.

B. In-process inspection frequency and/or sample plan and procedures.

C. Personnel responsible for performing in-process inspection.

D. Documentation format and requirements (methods).

E. Accept/reject material policy and procedures.

VI. Final Inspection

A. Procedures, sampling plans, personnel responsibilities, documentation requirements.

B. Audit Procedures

C. Accept/reject material policy and procedures.

VII. Gage Control – Outline a program that checks the calibration of all measuring and test

equipment, including production tools and fixtures used as a medium of inspection. This

program should outline:

A. Gages numbered and traceable to calibration records (company-owned and personal)

B. Calibration records maintained on a specified frequency

C. Calibration verification procedures

D. Established Gage Calibration Frequency

E. Master gages and appropriate test equipment certified by an agency authorization to

provide traceability to the National Bureau of Standards.

F. The frequency requirement for master gages and appropriate test equipment certification

should be clearly stated.

G. Documentation format and requirements (methods)

VIII. Preventive Maintenance

A. Identification of applicable equipment

B. Outline of prevention activity

C. Documentation of requirements

IX. Complaint Response and Follow-up Procedure

A. Returned and failed material analysis

B. Response to customer (corrective action)

X. Suspect Material Identification and Isolation Procedures

XI. Material Deviation Request Processing and Handling Requirements

XII. Training Program or procedures

XIII. Customer Initial Sample Requirements Procedure


XIV. Document Control and Record Retention Policy – Design Control, Inspection and Test

Records

XV. Internal Quality System Audit Procedures

3.4 Supplier Responsibility

3.4.1 Quality Planning

For projects relating to new products, services, or processes, the supplier/subcontractor shall prepare, as

appropriate, written quality plans consistent with all other requirements of a company’s quality system. The

supplier shall review all requirements specified on Sherwood drawings during the review phase to assure that

compliance can be attained. The supplier shall develop and have available a quality process control plan for

each product, process or service used to produce Sherwood parts. The plan will be organized in a material flow

sequence from receiving material to shipping and will include a list of critical characteristics to be controlled,

sample sizes, frequency of inspection, measurement methods, personnel responsible, records to be kept, and

problem reaction plan. For proprietary process characteristic, applicable supplier/subcontractors standard may

be referenced. The Quality Process Control Plan shall be considered to be dynamic and shall be reviewed and

updated as required.

3.4.2 Critical Characteristics

Sherwood Engineering, Quality and the supplier shall identify critical characteristics via formal or informal

disposition. Critical characteristics are defined as those in which a deviation from specification could possibly

result in: damage to the product, less than a safe operating condition, noncompliance with applicable

regulations, an unreasonable number of field service calls, and significant customer dissatisfaction with form, fit

and/or function, or high internal cost.

3.4.3 First Article Inspection

Supplier First Article Inspections (FAI) will be coordinated per Sherwood Supplier Sample Submission

Procedure SQR-2.0.

3.4.4 Deviation Request

Sherwood requires its suppliers to manufacture all parts to required specifications. The supplier is not to deviate

from the processes and materials approved through FAI. No deviations will be accepted without written

approval from Sherwood prior to the change being implemented. If a deviation from specifications

becomes necessary, a request in writing shall be made to Sherwood Purchasing or Quality department. Included

in the deviation request should be the following: purchase order number, shipment due date, part number, part

description, affected quantity, explanation, recommendations and corrections. The deviations should also

include a statement assuring that it will not affect safety and /or efficacy. An approval must be obtained prior to

shipment. Sherwood will take all requests under advisement, however is under no obligation to accept them. If

the reason for the deviation is the part cannot be manufactured to the Sherwood print specifications, the supplier

is responsible for informing Sherwood Purchasing and Quality of this problem immediately. The supplier is

responsible for checking the print revisions against the revision on Sherwood Purchase Orders. If the two

revisions do not match, the supplier is responsible for notifying Sherwood Purchasing and Quality departments

of this discrepancy immediately.

3.4.5 Training

The supplier shall establish and maintain procedures for identifying the training needs and provide for the

training of all personnel performing activities affecting quality. Personnel performing specific assigned tasks

shall be qualified on the basis of appropriate education, training and/or experience, as required. Sherwood’s

Quality Assurance may assist in recommendation for training needs. Appropriate records of training shall be

maintained.

Training subjects shall include but not be limited to:

Manufacturing techniques/operator instructions

Quality Systems Training

Process Control


Safety

Customer Requirements

3.4.6 Records

The supplier shall maintain a file containing the following items current and/or active:

Purchase Order

Process Control plan with inspection results for each shipment

All part drawings and specifications with correct engineering revision level

Process control charts where applicable

Deviations authorized by Sherwood

Device History Records

Training

4.0 Assurance of Product and Process Quality

4.1 Source Inspection

Sherwood reserves the right to inspect, at the supplier/subcontractor’s facility, any product, material or parts

furnished to Sherwood by purchased agreement. Sherwood also reserves the right to perform periodic audits and

appraisals of a supplier/subcontractor’s quality system, inspection/testing operations, quality records and any

information associated with the production of Sherwood parts. Sherwood’s Quality Assurance may conduct

source inspections. Source inspections and appraisals do not constitute or imply acceptance of a

supplier/subcontractor’s material, service, or parts. They do not relieve suppliers of the responsibility for

maintaining a quality system and inspection procedure to ensure acceptable product and service quality.

4.2 Design/Process Change Control

In the event a supplier/subcontractor wishes to make changes (including processes and materials) to any stock

and/or proprietary part supplied under a Sherwood part number, the supplier/subcontractor must notify

Sherwood Purchasing per the purchase order. The supplier/subcontractor shall submit a copy of a revised

drawing indicating the change. Purchasing will submit the drawing to Sherwood Engineering for concurrence

and update the Sherwood drawing.

Written authorization must be obtained from Sherwood Engineering and Quality prior to incorporating

any design changes on any product or component part supplied to Sherwood. It is the

supplier/subcontractor’s responsibility to notify Sherwood of any process change that affects Sherwood

designed parts or products. Sherwood Quality will determine if a first piece sample inspection is required.

The supplier/subcontractor must complete all verifications and tests necessary to ensure that products continue

to meet Sherwood specifications. The supplier/subcontractor must provide documentation on any change to

cost, planning and appropriate proof of good reliability.

4.3 Manufacturing Control

The supplier/subcontractor must have a system for inspection and test of component parts and materials as

received, during manufacturing, processing, and assembly. This system must provide assurance that the

part/material continues to meet the physical, chemical, visual, dimensional, and other specified requirements.

Within the supplier/subcontractor’s system there must be provision to indicate the acceptance status and

conformance or nonconformance of the product with regard to inspection and test(s) performed. The

identification of the quality status shall be maintained as necessary, throughout production. The purpose is to

insure that only product that is in conformance with planned quality specifications is passed on to subsequent

operations or customers.

The system must assure that prior to shipment all material meets the physical, functional, chemical, visual and

dimensional requirements in accordance with the purchase order and all applicable specification.


4.4 Nonconforming Material

Material that is found to be nonconforming at Sherwood shall be rejected, the supplier/subcontractor shall be

contacted and the material returned for full credit or refund. All expenses associated with inspection, sorting,

packing, reworking, transporting, storing, and shipping nonconforming materials shall be the sole responsibility

of the supplier/subcontractor.

When nonconforming material is identified, it will be charged against the supplier rating. The

supplier/subcontractor will be notified of the problem by phone, email or fax. It is the supplier/subcontractor’s

responsibility to verify existing stock and determine containment and corrective action. The

supplier/subcontractor will be issued a copy of the Material Variance Report and, as determined necessary,

Supplier Corrective Action Request per section 3.2.3. Sherwood reserves the right to charge the supplier for any

damages incurred from nonconforming material.

5.0 Documentation of Process Quality

5.1 Internal Quality System Audit

All elements, aspects and components pertaining to a quality system shall be internally audited and evaluated on

a regular basis. Audits shall be carried out in order to determine whether various elements within a quality

management system are effective in achieving stated quality objectives. For this purpose, an appropriate audit

plan should be formulated and established by company management.

Audit findings, conclusions and recommendations should be submitted in documentary form for consideration

by appropriate members of company management.

The following items shall be covered in the reporting and follow-up of audit findings:

Specific examples of noncompliance or deficiencies, possible reasons for such deficiencies where evident,

may be included.

Appropriate corrective actions may be suggested.

Implementation and effectiveness of corrective actions suggested in previous audits shall be assessed.

5.2 Quality Improvement Action System

The supplier/subcontractor shall provide for a system to process Sherwood’s complaints. The system shall

coordinate and analyze the product problems Sherwood is having with the supplier/subcontractor’s material or

products. The response and feedback shall be part of the supplier/subcontractor’s quality improvement action

plan.

A defined corrective action plan shall be included within the supplier/subcontractor’s quality improvement

action plan. This plan shall provide for the coordination, recording and monitoring of corrective action with

intent of eliminating or minimizing the recurrence of the problem.

5.3 Calibration/Maintenance of Gages

The supplier/subcontractor shall implement a form of gage calibration system for any equipment used for

acceptance activity. Applicable inspection measuring, process instrumentation, and test equipment, including

production tools and fixtures used as a medium of inspection, must themselves be inspected and calibrated at

established intervals. The equipment’s function, service conditions, use and maintenance, and recognized

industry standards determine the frequency of calibration.

Calibration shall be performed under controlled conditions of temperature, cleanliness and humidity based on

the type of product provided. Service conditions should be similarly controlled to ensure accuracy of

measurement.

Either the supplier or their commercial calibration facility shall calibrate test equipment or a commercial facility

in accordance with recognized measurement standards, i.e. National Institute of Standards and Technology.

Calibration performed by a commercial facility and/or in-plant shall be supported by reports or data sheets

certifying the date and accuracy of each instrument. These reports must be maintained on file by the

supplier/subcontractor and made available for review by Sherwood’s Quality.


6.0 Supplier Evaluation

6.1 Supplier Development

The supplier/subcontractor must assume full responsibility for the quality, delivery, and reliability of all

products, materials and/or services provided to Sherwood. Sherwood may assist suppliers/subcontractors in

their quality system development and maintenance. The supplier/subcontractor must strive to provide products

to or for Sherwood that will not require inspection. The supplier/subcontractor must establish a continuous

improvement program that strives to improve product quality and eliminate rejections.

6.2 Performance Monitoring

Sherwood Purchasing and Quality departments will work in conjunction to regularly measure suppliers in terms

of quality and delivery in order to quantify supplier/subcontractor performance.

Material Variance Reports (MVR’s) are completed to document any non-conformances found on received

goods. A Supplier Corrective Action Request (SCAR) may be used for the supplier to respond with actions to

correct and prevent recurrence of a problem. Quality will track these documents to assure conformance and

work with Purchasing to take actions on those Suppliers continually not meeting expectations.

Purchasing will monitor the On-Time Delivery of suppliers. Those suppliers not meeting the expectations of

Sherwood Valve, LLC will be required to submit actions through a SCAR to drive improvement.

6.3 Disqualification

It is the supplier/subcontractor’s responsibility to supply material, which conforms to specification. When the

supplier supplies material found to be non-conforming and unusable by Sherwood, it is the

supplier/subcontractor’s responsibility to credit Sherwood for that material, including any value added by

Sherwood.

Items supplied on the purchase order may be subject to an approved statistical sampling plan upon receipt.

Should the sample fail to pass the sampling criteria, the lot shall be rejected, or as conditions dictate, be

subjected to subsequent re-inspection or 100% lot sorting.

Sherwood will debit the supplier/subcontractor’s account with an agreement amount. Material will be returned

freight at the supplier’s expense with replacement material to be shipped prepaid.

If the supplier fails to deliver defect-free products, does not react promptly to problem situations including

reliability failures, or becomes negligent in meeting promised delivery dates, Sherwood will take steps to

disqualify the supplier which include:

1) A notification letter provided to the Supplier by Quality and/or Purchasing.

2) A review of products which are supplied by the Supplier and may be affected by the Supplier’s

disqualification.

3) Deactivation of the Vendor Account Number in the ERP system.

6.4 Current Suppliers

Current supplier performance will be reviewed periodically by Sherwood’s Purchasing and Quality. Suppliers

are encouraged to strive for continuous improvement.

7.0 Cost Reduction Activities

Sherwood suppliers/subcontractors shall have a continuous improvement philosophy indoctrinated within their

organization. Innovation and cost reduction activities are highly encouraged. Suppliers are expected to share

any cost savings with Sherwood via material, process, design or supplier changes implemented that result in

overall cost reduction. Sherwood requests that suppliers annually review their activities for possible cost

reductions and submit to Sherwood Purchasing any information that will result in cost reduction.


8.0 Rewards

Suppliers with good performance will receive preference for new and future business.

9.0 Supplier Traceability

Supplier Traceability will be coordinated per Supplier Material Traceability and Lot Code Requirements

Procedure QSP-6.7.

10.0 Appendix

10.1 Candidate Supplier/Subcontractor Quality Evaluation Report

A self-evaluation and/or report to be used for new supplier selection, corrective action, re-certification, or

updates to supplier files.

10.2 Supplier Quality System Self-Assessment Questionnaire

A self-evaluation and/or report to be used for evaluation of Non-Critical Suppliers

10.5 Supplier Corrective Action Requests

Form to be submitted to supplier as a result of a nonconformance.

10.7 Certification of REACH Compliance

Suppliers evaluate their materials to the REACH directive and sign if compliant.

10.8 Certification of RoHS Compliance

Suppliers evaluate their materials to the RoHS directive and sign if compliant.

10.9 Conflict Minerals Questionnaire and Certification

Suppliers evaluate their materials to the SEC regulations for Conflict Minerals, complete, and sign the form.

APPENDIX

SHERWOOD SUPPLIER QUALITY EVALUATION REPORT

SUPPLIER QUALITY MANUAL PAGE 1 of 8 SQCF-4012 APPENDIX 10.1

CANDIDATE SUPPLIER/SUBCONTRACTOR QUALITY EVALUATION REPORT

SUPPLIER (NAME, ADDRESS, PHONE) DATE

PERSONNEL CONTACTED TITLE OR POSITION

ITEMS (S) CONSIDERED FOR PURCHASED FROM PRODUCTS SUPPLIED TO SHERWOOD THIS SOURCE

REASONS FOR EVALUATION QUALITY SYSTEM STANDARD USED FOR EVALUATION

NEW SUPPLIER CORRECTIVE ACTION

(Re) CERTIFICATION UPDATE SUPPLIER FILES

RECOMMENDED DISPOSITION

APPROVED DISAPPROVED CONDITIONALLY APPROVED

CERTIFICATION

SUMMARY AND RECOMMENDATIONS

EVALUATION BY (NAME & TITLE) DATE EVALUATION BY (NAME & TITLE) DATE



* When an answer is NO, please complete the following:

NOTE: Self-evaluation

requires written explanation when answer is NO

Audit requires objective evidence when answer is NO

1.0 QUALITY ASSURANCE ORGANIZATION (ISO 9001:2008, ISO 13485:2003, 4.1, 4.2, 4.17) YES NO* N/A POINTS (GMP 820.20, 820.22)

1.1 Is there a separate Quality function within the company? (1)

1.2 Does the supplier operate under a recognized quality system? What are the timelines? (3)

1.3 Has the supplier’s management defined and documented its policy for quality, including objectives for quality and its commitment to quality. (1)

1.4 Are the Quality Assurance organization’s authorities and responsibilities clearly defined in writing? Is an organization chart available? (2)

1.5 Is there a Quality Assurance Manual depicting the latest revisions? (1)

1.6 Is there a system for continual maintenance and updating of a Quality Assurance Manual? (1)

1.7 Does the supplier have a documented training program in place? (1)

1.8 Are records of the management quality system review and resulting corrective actions maintained? (1)

1.9 Are routine internal audits performed? (1)

Total (12 Possible Points)

2.0 CONTROL OF PROCURED SUPPLIES (ISO 9001:2008, ISO 13485:2003, 4.5, 4.6, 4.10.2) (GMP 820.50, 820.86, 820.90)

2.1 Does the Quality Assurance organization have a program for Supplier Quality including approval of suppliers? (1)

2.2 Does the supplier’s Quality Assurance system require their own suppliers to have adequate Quality Assurance programs? (1)

2.3 Does the supplier purchase order clearly specify acceptance criteria? (1)

2.4 Are all required drawings, engineering orders, specifications, and other such materials readily accessible? (1)

2.5 Are obsolete drawing and specifications removed from use? (1)

2.6 Is there a system that provides assurance that the material meets all physical functional, chemical, visual and dimensional requirements?(1)

2.7 Is their an effective system for the control of all material? (1)

2.8 Is sampling inspection, when applicable, performed in compliance with established, recognized standards? (1)

2.9 Are the measuring devices, inspection gauges and test equipment available to source inspectors and receiving inspectors, adequate for the inspection and test purposes required? (1)



2.0 CONTROL OF PROCURED SUPPLIES (CONT) YES NO* N/A POINTS

2.10 Does the supplier use a positive means of identifying status of all raw stock? (pass/fail) (1)


3.0 MANUFACTURING CONTROL (ISO 9001:2008, ISO 13485:2003 4.9, 4.10.3,4.13.2) (GMP 820.70, 820.75, 820.80)

3.1 Is the work environment suitable for acceptable working conditions? (1)

3.2 Are all required drawings, engineering orders, specifications and other such materials readily accessible to manufacturing personnel? (1)

3.3 Are there proper processing instructions at each manufacturing operation? (1)

3.4 Are the process and product characteristics that affect quality monitored during manufacturing? (2)

3.5 Is there evidence of process validation, with appropriate process control, being maintained? (1)

3.6 Is all inspection software validated? (1)

3.7 Is in-process material clearly identified as to status? (1)

3.8 Are special processes identified and documented? (1)

3.9 Are reworked materials reinspected and/or retested to assure conformance to specification? (1)

3.10 Are there written records indicating that personnel are adequately trained? (1)




4.0 FINAL INSPECTION (ISO 9001:2008, ISO 13485:2003, 4.10.4) YES NO* N/A POINTS (GMP 820.80)

4.1 Are all finished goods approved to insure that contract requirements have been met? (1)

4.2 Are all inspection and test records reviewed and verified that the item has been inspected and are records accurate and complete? (1)

4.3 Is sampling inspection, when applicable, performed in compliance with established, recognized standards? (1)

4.4 Do final inspectors/auditors have ready access to all required drawings, engineering orders, specifications and other materials? (1)

4.5 Does the supplier maintain a system to prevent the unauthorized use of materials that have not yet been inspected? (1)


5.0 DOCUMENTATION CONTROL (ISO 9001:2008, ISO 13485:2003, 4.5, 4.5.2) (GMP 820.40)

5.1 Are the essential documents affecting quality reviewed for adequacy and approved for release by authorized personnel? (1)

5.2 Is a master list available for the identification of all controlled documentation? (1)

5.3 Are current issues of these documents available and accessible at all applicable functional areas? (1)

5.4 Are provisions made to require that processing of changes in writing and are records of changes made maintained? (1)

5.5 Are obsolete documents promptly removed from all points of use? (1)




6.0 MEASURING DEVICES AND TEST EQUIPMENT (ISO 9001:2008, ISO 13485:2003, 4.11) YES NO* N/A POINTS (GMP 820.72)

6.1 Does the organization maintain procedures that call for the periodic inspection and recalibration of all measuring devices, gauges and production tools used as a medium for inspection or product acceptance? (1)

6.2 Are calibration standards traceable to *NIST? (1)

6.3 Are employee owned tools and gauges used in production or inspection. (1)

6.4 Do all measuring devices, gauges and test equipment items carry identification and status indicating the most recent calibration date and the date when the next calibration is to be performed? (1)

6.5 Are calibration records accurate and up-to-date? (1)

6.6 Is corrective action taken when the measurements system variation is determined to be excessive? (1)

6.7 Is equipment that is past the calibration date, not calibrated, or damaged, in use? (1)

6.8 Are measuring devices, gauges, and test equipment not used for inspection or product acceptance identified? (1)


7.0 CONTROL OF NONCONFORMING PRODUCTS (ISO 9001:2008,ISO 13485:2003, 4.13) (GMP 820.90)

7.1 Does the supplier maintain a documented system for the handling of nonconforming materials? (1)

7.2 Does the supplier maintain a system for segregating nonconforming supplies/ material to avoid inadvertent use? (1)

7.3 Does the supplier have a procedure for requesting a deviation from the customer when material does not conform to specification? (1)

7.4 Is material that is removed from the process flow identified as to its status? (1)

7.5 Is the final disposition of nonconforming material(s) recorded and traceable? (1)




8.0 CORRECTIVE / PREVENTIVE ACTIONS (ISO 9001:2008, ISO 13485:2003 4.14) YES NO* N/A POINTS (GMP 4.14)

8.1 Does the supplier maintain a system for taking corrective action in order to prevent repetitive discrepancies? (1)

8.2 Is the supplier’s corrective action system one that permits prompt remedial actions? (1)

8.3 Does the supplier maintain a system for following up on all corrective action requests? (1)

8.4 Are reports on corrective actions regularly prepared and reviewed by management? (1)


9.0 ENVIRONMENTAL REQUIREMENTS AND CONTROL (No points) 9.1 Do the products require a controlled environment?

9.2 Is there a documented program?

9.3 Is monitoring performed?

9.4 Under comments, list types of environmental control utilized, i.e., *ESD, chemical monitoring **RF etc.

9.5 Is the use of food, beverage and tobacco restricted in manufacturing areas?

* Electrostatic Discharge ** Radio Frequency 10.0 FACILITY 10.1 Type of Building 10.1.1 Brick, Wood, etc.

10.1.2 Number of Stories

10.1.3 Approximate age



10.0 FACILITY (CONT) 10.2 What is the condition of the building?

10.2.1 General housekeeping: clean, uncluttered, etc.?

10.2.2 Is there adequate lighting and work space?

10.2.3 Is there adequate storage for raw materials, tools, etc.?

10.2.4 Manufacturing Space (ft²) Q.C. Space

10.3 Equipment 10.3.1 Type of Equipment?

10.3.2 General condition of equipment: clean, well maintained, etc.?

10.3.3 Approximate age of equipment?

11.0 ORGANIZATION 11.1 Number of Employees?

11.2 Union or Non-Union Shop?

11.3 Number of People in Production

Maintenance

Quality



CANDIDATE SUPPLIER/SUBCONTRACTOR QUALITY EVALUATION REPORT

SUMMARY

SECTION POSSIBLE POINTS ACTUAL POINTS

1.0 Quality Assurance Organization 12

2.0 Control of Procured Supplies 10

3.0 Manufacturing Control 11

4.0 Final Inspection 05

5.0 Document Control 05

6.0 Measuring Devices and Test Equipment 08

7.0 Control of Nonconforming Products 05

8.0 Corrective Actions 04

Total Points

60

Acceptance Criteria: 56-60 Acceptable (Approved)

50-55 Conditional (Conditionally Approved)

0-50 Unacceptable (Disapproved)

Note: Scores of 55 and below a will require corrective action and upon completion of the

identified findings a reassessment may be conducted.

Action Plan:

SUPPLIER QUALITY SYSTEM SELF-ASSESSMENT QUESTIONNAIRE


SHERWOOD is an ISO 9001:2008 registered company. To comply with ISO 9001:2008 requirements, we need to verify the quality system of our suppliers. We ask that you complete this self-assessment questionnaire, and return it within 10 days of receipt. Failure to respond to this request could result in your company being excluded as an approved supplier for Sherwood.

COMPANY INFORMATION

Company Name

Company Address

Phone # Fax #

Email # Number of Personnel:

Quality Manager Office

Engineering Manager Production

Technical Contact Quality Inspection

Sales/Customer Service

Industries supplied

Major Customers (optional)

THIS QUESTIONNAIRE WAS COMPLETED BY:

Name and Title Date

From the following lists, please indicate which commodities you are interested in, or currently supplying to Sherwood:

Buffing Assemblies Bar Stock / Rod

Cleaning4 Fabrications BC’s

Coating Gaskets / Seals Die Castings

Deburring Plastic Molding / Extrusion Electrical

Fasteners Rubber components Forgings

Heat Treat Soft Goods Gauges

Labels Springs Machined Parts

Packaging Materials Stampings O-rings

Plating Safety Discs

Printing Tubing

Calibration

If you have achieved a third part accreditation (i.e. ISO 9001, ISO 13485, ISO/IEC 17025) it will not be necessary to

complete the remainder of this questionnaire. Please provide a copy of your certificate and complete the following:

Standard Scope

Registration # Registrar

List other agencies that have approved your Quality System

Please return this completed questionnaire to:

Quality Assurance Department –Quality Engineer Sherwood Valve LLC 2200 N. Main Street Washington, PA 15301

Sherwood use only Reviewed by: Status: Accept

Date: Score: Reject



If you do not have a third party accreditation, please complete the remainder of this questionnaire.

To complete this questionnaire, please use the following codes to indicate the status of implementation in each area of your quality system.

CODE IMPLEMENTATION STATUS

0 Not in place, nor do we feel that it is necessary (N/A)

1 Not in place, but it would help us

2 Partially implemented. (explain all “2”’s and provide the expected full implementation date)

3 Fully implemented, documented, and operational, able to demonstrate through records.

Blank lines have been included after each major section for any comments or additional information you may wish to include. Feel free to submit any documentation that you feel would be useful in our evaluation of the status of your quality system.

SECTION 1: QUALITY SYSTEM ORGANIZATION AND MANAGEMENT 0 1 2 3

1.1 Is there someone on the management team with specific responsibility and authority for quality? 0 1 2 3

1.1 Do you have a quality manual describing your quality system? 0 1 2 3

1.1 Do you have plans/procedures to maintain and/or upgrade your equipment and facilities? 0 1 2 3

1.1 Do you have a process to review and improve your product? 0 1 2 3

1.1 Does your management team have meetings to review the quality system? 0 1 2 3

1.1 Are there plans to develop a quality system that meets ISO 9000 standards? 0 1 2 3

1.1 Do you periodically conduct internal audits of your quality system? 0 1 2 3

1.1 Do you have procedures to review purchase orders and contracts to determine if you will be able to meet delivery, quantity and quality requirements?

0 1 2 3

TOTALS

Comments:

SECTION 2: CONTROL OF PURCHASED MATERIAL 0 1 2 3

2.1 Do you review what your suppliers are doing to ensure that they consistently provide materials/services that conform to your requirements?

0 1 2 3

2.1 Do you have procedures to inspect materials from your suppliers? 0 1 2 3

2.1 Do your Purchase Orders clearly specify your product quality requirements? 0 1 2 3

2.1 Do you have procedures to inform suppliers when their material doesn't meet your requirements, and do you require corrective action?

0 1 2 3

TOTALS

Comments:



SECTION 3: PROCESS CONTROL 0 1 2 3

3.1 Do you have a documented plan that identifies where, when, and how critical characteristics are inspected for products that are similar to those you plan to supply to Sherwood?

0 1 2 3

3.1 Do you conduct process capability studies? 0 1 2 3

3.1 Do your operators have written work instructions, procedures, engineering drawings/specs? 0 1 2 3

3.1 Do you utilize Statistical Process Control to control your critical processes? 0 1 2 3

3.1 Can you provide Sherwood with evidence (records) to show conformance to specifications and/or requirements for all parts/components shipped to us?

0 1 2 3

3.1 Do you have procedures that allow you to identify the materials used (lot control) in products shipped to Sherwood and when those products were manufactured/assembled?

0 1 2 3

3.1 Do you have procedures to ensure that nonconforming product that you identify will not be shipped to Sherwood?

0 1 2 3

3.1 Do you have procedures to take corrective action on problems identified by nonconforming products and customer complaints?

0 1 2 3

TOTALS

Comments:

SECTION 4: CONTROL OF MEASURING AND TEST EQUIPMENT 0 1 2 3

4.1 Do you maintain a listing of all of the gages and other measuring and testing equipment? 0 1 2 3

4.1 Is inspection, measuring and test equipment calibrated against certified equipment traceable to the National Institute for Standards and Technology (NIST) or other? Identify other below.

0 1 2 3

4.1 Do you have a system/procedure to ensure that measuring and test equipment is recalibrated in the schedule that is specified for the equipment?

0 1 2 3

4.1 Are all production employees periodically tested in gage accuracy and precision to ensure effective/accurate measurement capability?

0 1 2 3

TOTALS

Comments:

SECTION TOTALS 0 1 2 3

SECTION 1: QUALITY SYSTEM ORGANIZATION AND MANAGEMENT

SECTION 2: CONTROL OF PURCHASED MATERIAL

SECTION 3: PROCESS CONTROL

SECTION 4: CONTROL OF MEASURING AND TEST EQUIPMENT

TOTALS FOR ALL SECTIONS

We at Sherwood thank you for your timely completion and return of this survey, and for working with us toward continuous improvements in Quality and Customer Satisfaction.

SUPPLIER CORRECTIVE ACTION REQUEST

SUPPLIER QUALITY MANUAL SQCF-4016 Rev. B APPENDIX 10.5

INSTRUCTIONS FOR COMPLETING SUPPLIER CORRECTIVE ACTION REQUEST 1. The Supplier Corrective Action Response (SCAR) must identify the action to be taken to address

the immediate problem and steps to prevent the recurrence of the problem. a. The corrective action response must be submitted in English within 14 days from the issuance

date. b. An interim response (containment) to nonconformance must be submitted within 48 hours of

issuance date, if applicable. c. Please “Sign” and “Date” the “Corrective Action” section of the form. Also include the

“Target Due Date” for the plan to be put in place. d. When the corrective action has been implemented, please “Sign” and “Date” the “Corrective

Action Implemented” section of the form. Include any supporting documentation as evidence that the corrective action has been completed.

2. Fax or e-mail the completed form and any additional documentation to the attention of , Fax

# or @sherwoodvalve.com.

NOTE: Failure to comply with the above instructions will adversely affect your Supplier Quality Rating.

SUPPLIER CORRECTIVE ACTION REQUEST

SUPPLIER QUALITY MANUAL SQCF-4016 Rev. B APPENDIX 10.5

COMPANY

ISSUANCE DATE

ADDRESS

SCAR #

MVR #

CONTACT

PART #

PHONE/ FAX

QTY REJECTED

PROBLEM DESCRIPTION:

CONTAINMENT ACTIONS (This section must be completed and returned within 48 hrs of the issuance date, if applicable):

INVESTIGATION PROBLEM FINDINGS:

CORRECTIVE ACTION (This section must be completed and returned within 14 days of the issuance date):

SUPPLIER SIGNATURE/ TITLE DATE IMPLEMENTATION DUE DATE

(For Sherwood use only):

SHERWOOD CONCURRENCE:

QUALITY ASSURANCE SIGNATURE TITLE DATE

VERIFICATION: STATUS: Closed Open

SIGNATURE DATE

SUPPLIER QUALITY MANUAL SQCF-4126 APPENDIX 10.7

SUPPLIER QUALITY MANUAL SQCF- 4127 APPENDIX 10.8

SUPPLIER QUALITY MANUAL SQCF-4128 APPENDIX 10.9