ML20237C100
| ML20237C100 | |
| Person / Time | |
|---|---|
| Site: | 07100420, 07100524 |
| Issue date: | 03/08/1995 |
| From: | Matthew Smith External (Affiliation Not Assigned) |
| To: | |
| Shared Package | |
| ML20237C097 | List: |
| References | |
| QP-01, QP-1, NUDOCS 9808200197 | |
| Download: ML20237C100 (4) | |
Text
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4 "STERIGENICS INTERNATIONAL, QP-01, REV 1.
PG 1 OF 4
-QUALITY ORGANIZATION 1PPROVALS:
SENIOR MANAGEMENT m
DATE:
3 0
QA-MANAGEMENT
/
DATE:
If
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1.0 SCOPE 1.1 QA Management is a separate entity reporting directly to SteriGenics International (SGI) Senior Management.
As used in this manual, QA Mangement relates to the functions necessary to comply with the requirements of 10 CFR 71.
2.0 RESPONSIBILITIES 2.1 QA Management has the responsibility and authority to implement and administer the QA system described in the Quality Policies (QP).
2.2 Supporting Quality Instructions (QI) are listed in Section 3.0 of this.QP.
3.0 POLICY 3.1 Throughout all SGI Quality Policies (QP) and Quality Instructions.(QI), the phrase "QA Management" will refer to the
- Manager,
. Corporate Technical Services" and designees and the phrase " Senior Management" will refer to-the Vice-President, Quality Assurance / Regulatory Affairs of SGI.
3.2 QA Management encompasses the following functional responsibilities:
3.2.1
- MANAGER, CORPORATE TECHNICAL SERVICES is directly responsible for QA Management I
reporting to the Vice President Technology /QA.
The authority'to establish and administer the QA system to satisfy the requirements of all contractual and regulatory criteria is i
assigned to the MANAGER, CORPORATE TECHNICAL SERVICES.
The
- MANAGER, CORPORATE TECHNICAL SERVICES shall have the responsibility to assign and/or
(
approve the quality level placed on SGI contracts and implement the specific QPs and
)
l-QIs applicable to the contract.
This will assure proper QA activity intensity in
)
response to contractual and regulatory
)
criteria.
1
<l 9908200197 990813 PDR ADOCK 07100420 C
- "STERIGENICS' INTERNATIONAL,-QP-01, REV 1 PG 2 OF 4
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While QA activities and functions may be delegated, the full responsibility of the SGI QA program remains with the MANAGER, CORPORATE TECHNICAL SERVICES.
3.2.2 QUALITY ENGINEERING is a QA function directly responsible to the
- MANAGER, CORPORATE TECHNICAL SERVICES.
It provides QA related design review, document review, procurement control, MRB and QA inspection instruction development functions.
3.2.3 QUALITY INSPECTION is a QA function that is also directly responsible to the MANAGER, CORPORATE TECHNICAL SERVICES.
It performs general inspection activities as directed by Quality Inspection Planning.
3.3-BasicL Quality Levels (QL) are assigned to all SGI activity for non-deliverable and deliverable product.
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The purpose of this is to assure QA support of individual j
-work to the stringency that reflects applicable contractual ~and regulatory criteria.
This assures efficient use of QA resources while maintaining Quality Levels that are expected by SGI, its customers and regulators.
The basic QL shall be QL 3.
QL 1 and 2 will be used when a graded QA approach is appropriate.
3.4 The Quality-Levels for all activities shall be established by Senior and/or QA Hanagement as follows:
3.4.1 QUALITY LEVEL "1"
shall pertain to activity requiring general or minimal QA participation.
3.4.2 QUALITY LEVEL "2"
shall pertain to activity controlled by nationally or internationally recognized Quality System criteria other than 10 CFR 71, Subpart H.
3.4.3 QUALITY LEVEL "3" shall pertain to 10 CFR 71, Subpart H and Nuclear Regulatory Commission issued Certificate of Compliance controlled activity.
3.5 Senior and QA Management shall also be responsible for implementing _ the QPs and QIs as appropriate to each contract.
3.6-It is SGI philosophy that Quality must be placed in product, documents, design, procurement, fabrication, maintenance and operation by the personnel creating them; that Quality cannot be inspected into the product.
.STERIGENICS INTERNATIONAL, QP-01,'REV 1 PG 3 OF 4 Therefore, a quality attitude must be integral to all efforts,at SGI.
Quality is, in actuality, the responsibility of all personnel in the. company.
3.7 QA Management's most important responsibility, therefore, is establishment and maintenance of a. good quality attitude
.throughout the organization.
This is established by example and company wide training programs emphasizing SGI's quality philosophy and. good quality practices and techniques.
3.8 The general organization chart for SGI is shown as
" Exhibit A" to this QP.
4.0 REFERENCE DOCUMENTS 4.1 QI-01, " Quality Organization".
4.2-QI-16, " Terms and Definitions".
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- * * ~STERIGENICS INTERNATIONAL, QP-01, REV 1 PG 4 OF 4 EXHIBIT A SteriGenics International GENERAL ORGANIZATION /QA CHART mumm __m_mm_m_wm CEO mem PRESIDENT s
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VICE PRESIDENT em-QA/RA mem-mmmmmmmmmmmmmm-mmmmmmmmmmmmmmmmmmmmm-m mmmmmmmmmmmmmme mammmmmmmmmmmme mmmmmmmmmmmmmmm MANAGER GENERAL DIRECTOR TECHNICAL SERVICES MANAGER CORPORATE QA mmmmmmmmmmmmmme MANAGER FACILITY QA
__mm_m_mmmm_wm_
TECHNICIAN FACILITY QA l
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