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    Quality Assurance Manual (QAM-1)Table of ContentsRevision 4

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    ProcedureNumber

    QAM-001

    Type:

    QUALITY ASSURANCE

    Revision Number:

    4

    Title:

    QUALITY ASSURANCE MANUAL

    Effective Date:

    2/15/2010

    REVISION SUMMARY

    Revision Date Description of Change Affected Pages

    0 4/22/02 Original Issue All

    1 4/24/03 Various minor editorial changes Various

    2 1/2/07 Reformatted. No substantive changes. All

    3 4/1/08 Complete Reissue All

    4 2/15/10 Section 17 revised Section 17

    Approved By: A. J. Armbrust - Signature on file Date: 2/15/2010

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    Quality Assurance Manual (QAM-1)Table of ContentsRevision 4

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    Table of Contents

    Table of Contents ............................................................................................................ iiList of Effective Pages .....................................................................................................ivQuality Assurance Introduction ....................................................................................... 1Terms and Definitions ..................................................................................................... 4SECTION 1 - ORGANIZATION ....................................................................................... 1

    QA FORM 1-1: STOP WORK ORDER FORM ............................................................ 6SECTION 2 - QUALITY ASSURANCE PROGRAM AND TRAINING .............................. 1

    QA FORM 2-1: NEW HIRE INDOCTRINATION RECORD .......................................... 7QA FORM 2-2: TRAINING MEETING RECORD ......................................................... 8QA FORM 2-3: TRAINING ASSIGNMENT (READING) .............................................. 9QA FORM 2-4: ON-THE-JOB TRAINING RECORD ................................................. 10SECTION 3 - DESIGN CONTROL .................................................................................. 1QA FORM 3-1: DESIGN CHANGE AUTHORIZATION ................................................ 4

    SECTION 4 - PROCUREMENT DOCUMENT CONTROL .............................................. 1SECTION 5 - INSTRUCTIONS, PROCEDURES AND DRAWINGS ............................... 1SECTION 6 - DOCUMENT CONTROL ........................................................................... 1

    QA FORM 6-1: DOCUMENT TRANSMITTAL ............................................................. 6SECTION 7 - CONTROL OF PURCHASED ITEMS AND SERVICES ............................ 1

    QA FORM 7-1: SUPPLIER EVALUATION AND QUALIFICATION RECORD ........... 11QA FORM 7-2: SUPPLIER EVALUATION QUESTIONNAIRE .................................. 12QA FORM 7-3: SUPPLIER RE-EVALUATION .......................................................... 15QA FORM 7-4: SOURCE INSPECTION REPORT .................................................... 16QA FORM 7-5: PURCHASE REQUISITION .............................................................. 17QA FORM 7-6: PURCHASE ORDER (TYPICAL) ...................................................... 18QA FORM 7-7: GENERAL TERMS AND CONDITIONS ........................................... 19QA FORM 7-8: SAMPLE CONSULTING AGREEMENT ........................................... 22

    SECTION 8 - IDENTIFICATION AND CONTROL OF ITEMS ......................................... 1QA FORM 8-1: CHAIN OF CUSTODY RECORD (TYPICAL) ..................................... 6

    SECTION 9 - CONTROL OF PROCESSES ................................................................... 1QA FORM 9-1: PROCESS REVIEW PLANNING CHECKLIST ................................... 4

    SECTION 10 - INSPECTION .......................................................................................... 1SECTION 11 - TEST CONTROL .................................................................................... 1SECTION 12 - CONTROL OF MEASURING AND TEST EQUIPMENT ......................... 1QA FORM 12-1: CALIBRATION HISTORY RECORD ................................................. 4SECTION 13 - HANDLING, STORAGE AND SHIPPING ................................................ 1

    QA FORM 13-1: MAINTENANCE RECORD ............................................................... 3SECTION 14 - INSPECTION, TEST AND OPERATING STATUS.................................. 1SECTION 15 - CONTROL OF NON-CONFORMING ITEMS .......................................... 1

    QA FORM 15-1: NON-CONFORMANCE REPORT .................................................... 4QA FORM 15-2: NON-CONFORMANCE REPORT LOG ............................................ 5

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    SECTION 16 - CORRECTIVE ACTION .......................................................................... 1QA FORM 16-1: CORRECTIVE ACTION REQUEST .................................................. 4

    QA FORM 16-2: PREVENTIVE ACTION REQUEST .................................................. 5

    SECTION 17 - QUALITY ASSURANCE RECORDS ....................................................... 1TABLE 17-1 - RECORD RETENTION MATRIX .......................................................... 5

    Section 18 - AUDITS ....................................................................................................... 1QA FORM 18-1: AUDIT FINDING FORM .................................................................... 5QA FORM 18-2: AUDIT OBSERVATION FORM ......................................................... 6

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    List of Effective Pages

    Section Revision

    TC-I through TC-iii 4

    Intro-1 through Intro-8 3

    1-1 through 1-2 3

    2-1 through 2-2 3

    3-1 through 3-2 3

    4-1 through 4-2 25-1 through 5-2 3

    6-1 through 6-2 3

    7-1 through 7-2 3

    8-1 through 8-2 3

    9-1 through 9-2 3

    10-1 through 10-2 3

    11-1 through 11-2 3

    12-1 through 12-2 3

    13-1 through 13-2 3

    14-1 through 14-2 3

    15-1 through 15-2 3

    16-1 through 16-2 3

    17-1 through 17-5 4

    18-1 through 18-2 3

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    Quality Assurance Manual (QAM-1)IntroductionRevision 3

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    Quality Assurance Introduction

    The American Society for Quality defines quality assurance as the planned andsystematic activities implemented in a quality system so that quality requirements for aproduct or service will be fulfilled. Every product and service that we provide has qualityrequirements. Sometimes those requirements are specified by the customer, by federalor state regulations, or by industry standards. Sometimes we impose thoserequirements on ourselves to reduce the risk of failure associated with a product orservice.

    Philotechnics uses a graded approach to quality assurance, meaning that theapplication of quality requirements must be done in a manner consistent with the

    relative importance of the item or activity. The degree of control for a process should beproportional to the degree of risk associated with the process, risk being the likelihoodof a problem associated with the process and the impact of such a problem. Thoseprocesses which involve less risk have less formal and less pervasive quality controlswhich meet the minimum requirements of this manual. Processes which involve greaterrisk have more formal and more pervasive controls. This allows us to remaincompetitive and to provide to the customer those specific services which the customerwants, without charging the customer for quality controls which the customer does notneed and for which the customer does not want to pay. This graded approach requiresthe project or product manager to exercise judgment in the degree of control neededand requires a well trained work force. The managers application of these procedures

    is subject to review and evaluation during routine quality audits.

    The format of this manual is based on a quality standard called Quality AssuranceRequirements for Nuclear Facility Applications (NQA-1), which was issued by theAmerican Society of Mechanical Engineers (ASME) and approved by the AmericanNational Standards Institute (ANSI). The sections of this manual refer to thecorresponding section of NQA-1 and to 10 CFR Part 830.120, a federal regulationdealing with facilities operated for the Department of Energy, and ISO 9001, aninternational quality program standard. Other federal and state organizations haveissued their own requirements for quality programs, such as the EnvironmentalProtection Agency. It is not practical or reasonable to comply with all aspects of all

    governing regulations in all quality applications, and no attempt has been made to do soin this manual. Most regulatory agencies recognize this and require a project-specificQuality Assurance Project Plan (QAPP) or require compliance with the customersspecific quality procedures. The decision chart in this section provides guidance onwhen to use this manual.

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    This revision to the corporate quality assurance manual combines the former quality

    assurance manual and quality procedures manual into one document. QPM-001,Quality Procedures, is cancelled.

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    When to Use This Manual Decision Chart:

    DECISION

    NO

    YES

    Call for use of customer

    QA procedures?

    Do not use this manual. Use customer procedures.

    Call for use of QAPP?

    Develop a QAPP specifically for the project or

    contract using the contents of this manual as a

    basis. The QAPP can be a supplement to this

    manual or a substitute, depending on customer

    requirements.

    Involve design or

    fabrication OR require

    NQA-1 compliance?

    This manual and associated quality procedures

    must be complied w ith in their entirety f or that

    process or project.Involve management of

    NRC licensed facilities?

    Comply w ith applicable sections of this manual.

    Comply w ith sections 2, 5, 6, 9, 11, 12, 14

    Does the contractor project:

    Involve material processing- shipping, sorting,

    shredding, etc.?

    Comply w ith applicable sections of this manual.

    Comply w ith sections 2, 5-7, 9, 11-18.

    The remaining processes done by Philotechnics are small or closely

    regulated. The requirements of this manual and the procedures manual

    need to be followed only f or guidance w ith the follow ing exceptions:

    1. Perform QA training per section 2 for full time employees.

    2. Control M&TE per section 12.

    3. Comply fully w ith the manual for radioactive w aste shipments.

    4. Comply w ith section 7 purchasing requirements f or M&TE and

    w aste shipment, processing, packaging and disposal.

    1.

    2.

    3.

    4.

    5.

    Limited to packing for DOT

    approved containers,

    such as source

    encapsulation?Write a local, limited compliance

    procedure that covers issues such as

    materials, sketches and fabrication.

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    Quality Assurance Manual (QAM-1)IntroductionRevision 3

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    Terms and Definitions

    The following definitions are provided to ensure a uniform understanding ofselect terms as they are used in this manual:

    1. Acceptance Criteria Specified limits placed on characteristics of an item, process,or service defined in codes, standards, or other required documents.

    2. Assessment The act of reviewing, inspecting, testing, checking, conductingsurveillances, auditing, or otherwise determining and documenting whether items,processes, or services meet specified requirements. Senior management, projectstaff, or an independent organization, performs assessments.

    3. Audit - A planned and documented activity performed to determine by investigation,examination, or evaluation of objective evidence the adequacy of and compliancewith established procedures, instructions, drawings, and other applicabledocuments, as well as the effectiveness of implementation. An audit should not beconfused with surveillance or inspection activities performed for the sole purpose ofprocess control or product acceptance.

    4. Business Unit Managers Business Unit Managers as defined in the attachedprocedures shall indicate: Operations Manager, Project Manager, and FacilityManager.

    5. Certificate of Compliance (CoC) A document signed or otherwise authenticatedby an authorized individual certifying the degree to which items or services meetspecified requirements.

    6. Certification The act of determining, verifying, and attesting in writing to thequalifications of personnel, processes, procedures, or items in accordance withspecified requirements.

    7. Characteristic Any property or attribute of an item, process, or service that isdistinct, describable, and measurable.

    8. Condition Adverse to Quality An all-inclusive term used in reference to any ofthe following: failures, malfunctions, deficiencies, defective items, and non-conformances. A significant condition adverse to quality is one that, if uncorrected,could have a serious effect on safety or operability.

    9. Corrective Action Measures taken to rectify conditions adverse to quality and,where necessary, to preclude repetition.

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    10. Design Change Any revision or alteration of the technical requirements defined byapproved and issued design output documents and approved and issued changesthereto.

    11. Design Input Those criteria, parameters, bases, or other design requirementsupon which detailed final design is based.

    12. Design Output Drawings, specifications, and other documents used to definetechnical requirements of structures, systems, components, and computerprograms.

    13. Design Process Technical and management processes that commence withidentification of design input and that lead to and include the issuance of designoutput documents.

    14. Deviation A departure from specified requirements.

    15. Document Any written or pictorial information describing, defining, specifying,reporting, or certifying activities, requirements, procedures, or results.

    16. Guideline A suggested practice that is not mandatory in programs intended tocomply with a standard. The word shoulddenotes a guideline; the word shalldenotes a requirement.

    17. Inspection Examination or measurement to verify whether an item or activityconforms to specified requirements.

    18. Inspector A person who performs inspection activities to verify conformance tospecific requirements.

    19. Item An all-inclusive term used in place of any of the following: appurtenance,assembly, component, equipment, material, module, part, structure, subassembly,subsystem, system, or unit.

    20. Interim Storage: The period of time that documents can be held by the generatorprior to turn over to DCC.

    21. Measuring and Test Equipment (M&TE) Devices or systems used to calibrate,measure, gauge, test, or inspect in order to control or acquire data to verifyconformance to specified requirements.

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    22. Non-conformance A deficiency in characteristic, documentation, or procedure

    that renders the quality of an item or activity unacceptable or indeterminate.

    23. Objective Evidence Any documented statement of fact, other information, orrecord, either quantitative or qualitative, pertaining to the quality of an item oractivity, based on observations, measurements, or tests that can be verified.

    24.Procedure A document that specifies or describes how an activity is to beperformed.

    25.Procurement Document Purchase requisitions, purchase orders, drawings,contracts, specifications, or instructions used to define requirements for purchase.

    26.Qualification, Personnel The characteristic or abilities gained through education,training, or experience, as measured against established requirements such asstandards or tests, which qualify an individual to perform a required function.

    27.Qualification, Personnel The characteristic or abilities gained through education,training, or experience, as measured against established requirements such asstandards or tests, which qualify an individual to perform a required function.

    28.Quality Assurance (QA) All those planned and systematic actions necessary toprovide adequate confidence that a structure, system, or component will performsatisfactorily in service. In project management, quality assurance is those stepsundertaken to verify that the quality planning for the project is being properly appliedand that the project is employing all the quality processes needed to meetrequirements.

    29.Quality Assurance Project Plan (QAPP) a project-specific plan which supplantsand/or augments procedures in this manual and specifies quality requirements for aparticular task, project or contract.

    30.Quality Control As used in project management, quality control means monitoringspecific results to determine whether they comply with relevant quality standardsand identifying ways to eliminate causes of unsatisfactory performance.

    31.Quality Planning As used in project management, quality planning involvesidentifying which quality standards are relevant to the project or process anddetermining how to satisfy them. This is of particular important when developing aQuality Assurnace Project Plan (QAPP) for performing work under DOE, EPA orother federal or state regulations.

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    32.Quality Record A completed document that furnishes evidence of the quality of

    items and/or activities affecting quality.

    33.Preventive Action An activity directed toward eliminating the cause of potentialnon-conformances.

    34.Receiving Taking delivery of an item at a designated location.

    35. Repair The process of restoring a nonconforming characteristic to a conditionsuch that the capability of an item to function reliably and safely is unimpaired,although that item still does not conform to the original requirement.

    36. Rework The process by which an item is made to conform to original requirementsby completion or correction.

    37. Risk An expression of possible loss that considers both the probability of an eventcausing harm or loss and the consequences of that event.

    38. Scrap Items that cannot be repaired, reworked, or serve no useful purpose.

    39. Service The performance of activities such as design, fabrication, inspection,nondestructive examination, repair, or installation.

    40. Shall Refer to guidelinefor the definition.

    41. Should See definition of the term guideline.

    42. Special Process A process, the results of which are highly dependent on thecontrol of the process or the skill of the operators, or both, and in which the specifiedquality cannot be readily determined by inspection or test of the product.

    43. Supplier Any individual or organization that furnishes items or services inaccordance with a procurement document. An all-inclusive term used in place ofany of the following: vendor, seller, contractor, subcontractor, fabricator, consultant,and their sub tier levels.

    44. Surveillance The act of monitoring or observing to verify whether an item oractivity conforms to specified requirements.

    45. Testing An element of verification for the determination of the capability of an itemto meet specified requirements by subjecting the item to a set of physical, chemical,environmental, or operating conditions.

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    46. Traceability The ability to trace the history, application, or location of an item andlike items or activities by means of recorded identification.

    47. Use-as-is A disposition permitted for a nonconforming item when it can beestablished that the item is satisfactory for its intended use.

    48. Verification The act of reviewing, inspecting, testing, checking, auditing, orotherwise determining and documenting whether items, processes, services, ordocuments conform to specified requirements.

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    Quality Assurance Manual (QAM-1)Section 1. ORGANIZATIONRevision 3

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    SECTION 1 - ORGANIZATION

    A. REFERENCES

    NQA-1 Section 1ISO 9001-2000 Clause 5.5.110 CFR 830.120 Criterion 1

    B. APPLICABILITY. Per the decision chart at the front of this manual.

    C. PURPOSE AND POLICY

    1. The President, management and staff of Philotechnics, Ltd. are committed toproviding services and products that conform to the requirements, both specifiedand implied, of its customers. This commitment shall be met by ensuring that alllevels of the organization understand and adhere to quality policies andprocedures, work instructions, regulations, standards, specifications, andcontractual agreements.

    2. The organizational structure, functional responsibilities, levels of authority, andlines of communication for activities affecting quality shall be documented.Persons or organizations responsible for assuring that an appropriate qualityassurance program has been established and verifying that activities affecting

    quality have been correctly performed, shall have sufficient authority access towork areas and organizational freedom to identify quality problems and theirresolutions. Such persons or organizations shall have direct access to responsiblemanagement at a level where appropriate action can be effected. Such personsor organizations shall report to a management level such that required authorityand organizational freedom are provided, including sufficient independence fromcost and schedule considerations.

    3. The organizational structure and the responsibility assignments shall be such that:

    a. Quality is achieved and maintained by those who have been assignedresponsibility for performing work.

    b. Persons or organizations not directly responsible for performing the work verifyquality achievement.

    c. The individual(s) or organization(s) responsible for establishing and executingthis Quality Assurance Program may delegate any or all of the work to others,but shall retain responsibility.

    d. Responsibility for the control of further processing, delivery, installation, oroperation on nonconforming items shall be designated in writing.

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    e. Where more than one organization is involved in the execution of quality related

    activities, the responsibility and authority of each organization shall be clearlyestablished and documented.f. The external interfaces between organizations and the internal interfaces

    between organizational units, and changes thereto, shall be documented.Interface responsibilities shall be defined and documented.

    D. RESPONSIBILITIES

    1. The President of Philotechnics, Ltd. shall be responsible for ensuring the personsperforming quality functions such as inspection, test, examination, and audits havethe authority and organizational freedom to perform the following:

    a. Identify quality problemsb. Initiate and recommend solutions for quality problemsc. Verify implementation of solutions to problemsd. Control further processing or delivery of a nonconforming or deficient item(s)

    until proper disposition has occurrede. Provide support and coordination to project management and quality assurance

    personnelf. Resolve, with the QAM, conflicts pertaining to quality assurance requirements

    and other departments to ensure resolutions are such that they meet therequirements and intent of the Quality Assurance Program

    g. Participate in the Annual Assessment of the Quality Assurance Programh. Foster continuous improvement methods within the quality program

    2. The President may assign authority to administer the Quality Assurance Programto a Quality Assurance Manager (QAM) who reports to the president or adesignated Vice President. The duties and responsibilities of persons directlyinvolved with quality achievement are defined below and the main duties andresponsibilities of the QAM are as follows:

    a. Organize, develop, and administer the policies, procedures, and workinstructions required to meet customer and company quality objectives.

    b. Assist in the development and administration of the employee indoctrinationand training programs.

    c. Review and/or approve new and revised policies, procedures, work instructionsor project specific Quality Assurance Program Plans.

    d. Revise the Quality Assurance Program when required by corporate qualityobjective, customer specification, or regulatory changes.

    e. Perform internal and external Quality Assurance Program audits.

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    f. Train and qualify Auditors, Lead Auditors, Quality Assurance Representatives,

    and inspection and test personnel.g. Act as primary interface with customer representatives concerning qualityrelated issues.

    h. Oversee document control and quality assurance record maintenancemeasures.(1) Participate in management assessments of the Quality Assurance

    Program(2) Review non-conformance and corrective action reports, audit findings, and

    customer complaints for trends. Report results to management.(3) Provide support to project management, procurement and production

    departments for all Business Unit Managers.

    i. Monitor quality related activities throughout all levels of the organization.

    3. Certain projects may have an individual assigned primary responsibility for qualityat the project. In this manual, that individual is referred to as the Quality AssuranceRepresentative (QAR). If assigned, the main duties and responsibilities of theQuality Assurance Representative (QAR) who reports to the QAM are as follows:

    a. Implement the Quality Assurance Program requirements as they pertain to thenature of each business unit operation.

    b. Develop, approve, and ensure implementation of facility or project specificprocedures or work instructions.

    c. Perform or assign trained and qualified personnel to monitor and verifyinspection and test activities.

    d. Assemble and approve documentation packages required by contract;e. Monitor special process parameters such as those related to painting, welding,

    and contamination detection.f. Identify, resolve, and/or communicate quality related problems to the Quality

    Assurance Manager and Business Unit Managers.

    4. The main duties and responsibilities of the Project, Business Unit or FacilityManager as related to quality are as follows:

    a. Assure that work executed under his/her cognizance is performed inaccordance with applicable standards, specifications, procedures, workinstructions, and the requirements established in the Quality Assurance Manual.

    b. Assure that customer purchase order or contract document requirements areproperly reviewed, documented, and effectively communicated to alldepartments responsible for completing the scope of work.

    c. Interface with the QAM or the Business Unit QAR on matters concerning theachievement of quality.

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    d. Provide Quality Assurance Program assessment input.

    Quality Organization Chart

    President

    Vice President

    Project

    Manager

    Quality

    Assurance

    Representative

    QualityAssurance

    Manager

    5. Each Philotechnics, Ltd. employee shall be responsible for stopping his/her ownwork when continuation will produce or conceal results that are not in accordancewith the requirements of the Quality Assurance Program and/or the qualityrequirements of the specific activity. He/she shall be responsible for reportingsuch conditions to the QAM, the QAR, or the direct supervisor.

    6. The QAM, QAR, and project managers shall be responsible for determining andcommunicating quality assurance requirements to vendors, subcontractors, andconsultants. Purchase orders, contracts, statements of work, task records,drawings, or similar documents shall be used to document these requirements.

    E. STOP WORK

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    1. Each individual within the organization has the authority and responsibility to stop

    his or her work when continuation of the work will produce or conceal results thatare not in accordance with prescribed requirements or will create safety hazards.This individual is responsible for stopping work and immediately contacting theimmediate supervisor. The immediate supervisor shall contact the QualityAssurance Manager (QAM), the Quality Assurance Representative (QAR), or thesupervisor, business unit or project manager for quality related issues and theappropriate site safety representative for safety related matters to confirm thatwork should be stopped.

    2. If the immediate supervisor disagrees with the individual concerning the need tostop work, or if site or project management disagrees with the site safety or quality

    representative concerning the need to stop work, work shall be stopped until thematter is resolved and the resolution is documented.

    3. If a Stop Work Order (SWO) is deemed necessary for quality purposes, the QAM,QAR, or business unit or project manager shall take the following measures:

    a. Stop work.b. Obtain a SWO form, Form QF 1.2-1 and complete section 1.c. Complete part 2 of the form by describing the unacceptable condition(s) and the

    cause(s).d. Investigate the cause(s) of the condition and recommend corrective action

    measures in section 3 of the form.e. Forward the SWO Form to the appropriate Vice President for review and

    approval to implement corrective action measures.f. Implement corrective action measures and verify that the unacceptable

    condition is now in accordance with original requirements. Document theverification results in part 4 of the form.

    g. Obtain approval from the appropriate Vice President to lift and close the SWOand forward to document control (defined in section 6).

    F. QUALITY RECORDS

    The following documents shall be processed and maintained as quality records inaccordance with Section 17, Quality Assurance Records:

    Stop Work Order Form (Form QF 1-1); andSupporting documents to the Stop Work Order Form.

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    QA FORM 1-1: STOP WORK ORDER FORM

    Part 1 Originator Section Date: Affected Item or Activity and Unacceptable Condition:

    OriginatorSignature:

    Part 2 Corrective ActionProposed Corrective Action

    Action Proposed By: Date:

    Proposed Action Approved By: Signature Date

    Vice President or Project Manager

    Quality Manager (for quality related workstoppages)Safety Manager (for safety related workstoppages)

    Action Verified Complete: Signature Date

    Quality Manager, Safety Manager orProject Manager

    Vice President Review

    Upon review by the appropriate Vice President, this Stop Work Order is lifted.Send the original copy of the Stop Work Order to Corporate Document Control.

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    Quality Assurance Manual (QAM-1)Section 2 QUALITY ASSURANCE PROGRAM AND TRAININGRevision 3

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    SECTION 2 - QUALITY ASSURANCE PROGRAM AND TRAINING

    A. REFERENCES

    NQA-1 Section 2ISO 9001-2000 Clause 5.610 CFR 830.120 Criterion 1, 2, 9

    B. APPLICABILITY. Per the decision chart at the front of this manual.

    1. Unless required by the customer, formal documents pertaining to training,procedures, physical requirements, etc. need be written only when necessary to

    augment standard work instructions, job descriptions, job hazard analyses andother documentation which might exist.

    2. Training need not be conducted on procedures which are considered standardindustry practices unless required by a customer or unless deemed necessarybased on job site supervision or prior problems. Training on project-uniqueprocedures is required.

    C. PURPOSE AND POLICY

    1. Philotechnics, Ltd. shall maintain a formal Quality Assurance Program to ensure

    that our services and products conform to specified requirements and customerexpectations.2. This Quality Assurance Manual, when imposed by the decision chart, represents

    minimum corporate requirements. A Quality Assurance Project Plan (QAPP) mustbe developed for higher risk work or when required by the contract associated witha project. Generally, federal work requires the development of a project-specificQAPP or the adoption of that agencys quality umbrella.

    3. Regardless of the documentation associated with a project, an essential part ofquality assurance is that employees must be trained to do their jobs. No amount ofpaperwork can compensate for a lack of training.

    D. BASIC REQUIREMENTS

    1. The documented Quality Assurance Program shall identify the activities and itemsto which it applies. The program shall include consideration of technical aspectsof activities affecting quality and provide controls to an extent consistent with theirimportance. The program shall also provide the following:

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    a. Planning and accomplishment of activities affecting quality under suitably

    controlled conditionsb. Special controls, processes, test equipment, tools, and skills required to attainrequired quality and for the verification of quality

    c. Sufficient indoctrination and training of personnel performing activities affectingquality

    2. Management implementing the Quality Assurance Program, or portions thereof,shall regularly assess the adequacy of that part of the program for which they areresponsible and shall assure its effective implementation.

    3. Activities that require qualified inspection and test personnel shall be identified andthe minimum requirements for such personnel shall be defined in procedures or

    work instructions.4. Personnel shall be indoctrinated to the technical objectives and requirements ofapplicable codes, standards, and program elements specific to their job functions.

    5. Formal, documented training of personnel shall be required to perform inspectionand test activities.

    6. Performance of inspection and test personnel shall be reevaluated at periodicintervals not to exceed three years. The qualification of personnel shall becertified in writing.

    7. Special physical characteristics required in the performance of each activityincluding physical and vision examinations shall be defined in procedures or workinstructions.

    8. Personnel qualification records shall be established and maintained in accordancewith established procedures or work instructions.

    E. RESPONSIBILITIES

    1. The President of Philotechnics, Ltd. shall be responsible for the formation of thecompanys quality policies and objectives required to provide control over activitiesaffecting quality to an extent consistent with their importance. The President shallbe responsible for providing adequate resources such as sufficient skilledpersonnel, appropriate equipment, and suitable environmental conditions tosupport each Manager performing quality related activities. He or she shall alsobe responsible for creating an environment for continuous improvement by:

    a. Encouraging and sustaining a supportive style of managementb. Promoting values, attitudes, and behavior that foster improvementc. Setting clear quality improvement goalsd. Encouraging effective communication and teamworke. Recognizing successesf. Providing the training and education necessary to promote improvement

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    2. The President and appropriate members of the management staff shall assess theadequacy and effectiveness of the Quality Assurance Program on an annualbasis. This task may be delegated to a Vice President specifically assignedquality assurance responsibilities. At a minimum, this assessment shall addressthe following topics or actions:

    a. A review of the companys quality policy and quality objectivesb. A review of all existing Quality Assurance Procedures and work instructionsc. A review of all non-conformances, customer complaints, audit reports, and

    subsequent corrective or preventive actionsd. The need to provide additional employee training

    e. A review of service improvement issuesf. Assessment decisions, recommendations, and identified areas requiringcorrective or preventive actions shall be documented in a report. This reportshall indicate the following information:

    (1) Date of the Assessment(2) Assessment meeting attendees(3) All topics discussed(4) Individuals assigned to provide resolution of any identified corrective or

    preventive actions;(5) Target dates for the completion and/or implementation of corrective or

    preventive actions

    3. Each Philotechnics, Ltd. employee shall be responsible for the quality of their workand performing their assigned tasks in accordance with program policies,procedures, and work instructions.

    4. The Quality Assurance Manager (QAM) and cognizant managers shall beresponsible for the development, implementation, and subsequent revisions to theprogram. The documentation required to support and implement the programshall be as follows.

    (1) This Quality Assurance Manual establishes the basic and supplementalquality requirements for the company. The manual provides the QualityPolicy, the general philosophy with regards to quality, and a broaddescription of what shall be done to achieve quality, and if needed amore descriptive outline of what is to be done and also when, where,who, and how the work process or activity is to be accomplished.

    (2) Work Instructions or Business Unit specific programs and procedures shallprovide detailed requirements of how a particular task or complex activity

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    is to be accomplished. Such instructions or procedures shall be traceable

    back to and be in line with the requirements set forth in this manual.(3) Quality Assurance Program Plans (QAPPs) shall define additional qualityrequirements necessitated by the project scope of work, the client orregulatory expectations.

    (4) Documentation such as forms, check lists, inspection/test reports, auditreports, etc., that provide evidence of conformance to specifiedrequirements shall support the effectiveness of the program.

    5. Quality Program Manuals, Procedures, Work Instructions, specific programs andprocedures, and QAPPs shall be issued and controlled in accordance withSection 6, Document Control.

    6. The QAM and cognizant managers shall be responsible for identifying inspectionand test activities requiring qualified and certified personnel. The indoctrination,training and subsequent qualification of personnel performing such activities shallbe accomplished in accordance with this section.

    7. Quality Assurance Program audit personnel shall be trained, qualified, andcertified in accordance with this section. The Philotechnics, Ltd. Lead Auditor shallbe responsible for administering the training, qualification, and certificationprocess.

    F. INDOCTRINATION AND TRAINING

    1. Indoctrination and training shall be provided to personnel engaged in theperformance or management of the following activities:

    a. Designb. Procurementc. Contract Managementd. Fabricatione. Material/Item Processingf. Testingg. Inspectionh. Operatingi. Calibration

    j. Handling, Storage, and Shipping

    2. Indoctrination of newly hired personnel shall be provided before thecommencement of the assigned tasks. This indoctrination shall be documentedon a New Hire Indoctrination Record, Form QF 2-1, or a form with similar data and

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    shall be forwarded to Human Resources (HR) for retention as a corporate record,

    and at a minimum shall cover the following topics:

    a. The companys position on qualityb. General criteria, including applicable quality assurance codes/standards and

    proceduresc. Job responsibilities and authority

    3. The extent of additional training required shall be commensurate with the scope,complexity, and nature of the activity and the education, experience, previoustraining, and proficiency of the individual.

    4. Prior to the start of an assigned task, the individual shall be trained to fullyunderstand new procedures or revised procedures/ work instructions that havebeen affected by a major change associated with the assigned task and ifnecessary demonstrate proficiency before proceeding. Training may also includeunderstanding of the following:

    a. The Quality Assurance Program including quality terms and definitionsb. Customer specific requirementsc. Commonly used acronyms

    5. One or more of the following methods shall be employed to provide and documentthe required training:

    a. Training Meetings. Use Training Meeting Record, Form QF 2-2 or equivalent. todocument training conducted at meetings. Complete the form as follows:(1) Instructor(s)/Date: Self-explanatory.(2) Document Name(s): Instructor shall list what training documents are being

    covered.(3) Document Number: Instructor lists the unique number assigned to the

    document.(4) Revision Number: Instructor lists, if any, the revision of the document.(5) Attendees: Instructor shall have all attendees print their name legibly and

    then signature as indicated.

    b. Assigned Reading. Use Training Assignment (Reading), Form QF 2-3, todocument the reading of new or revised selected manual sections, procedures,work instructions, or externally provided training, which relates to theemployees job function.

    c. On-the-Job Training. Use On-the-Job Training Record, Form QF 2-4 todocument completion of this training.

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    6. All training documents are retained in the business unit. A copy of the trainingform may be provided to Human Resources to update the individuals personnelrecord and to allow corporate tracking of selected training..

    7. Individual managers must determine whether periodic evaluations of employeetraining needs and current training methods should be performed anddocumented to determine training effectiveness and the need to providerefresher or additional training.

    G. QUALITY RECORDS

    The following documents shall be processed and maintained as Quality Records inaccordance with Section 17, Quality Assurance Records:

    New Hire Indoctrination RecordsTraining Meeting RecordsTraining AssignmentsOn-the-Job Training RecordsEvidence of completed external trainingTraining program evaluations

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    QA FORM 2-1: NEW HIRE INDOCTRINATION RECORD

    Employee Name:

    Employee No.

    Work Location: Hire Date:

    Overview of the following checked topics was provided to the above named individual.

    The companys position on quality

    Quality Assurance Codes/Standards/Procedures

    Quality Assurance Program Elements

    Job Responsibilities and Authority

    OTHER

    Comments:

    Indoctrination Provided By: Date:

    Review: Date:

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    QA FORM 2-2: TRAINING MEETING RECORD

    INSTRUCTOR(S): DATE:

    DOCUMENT NAME DOCUMENT NUMBER REVISION NUMBER

    ATTENDEES:PRINTED NAME EMPLOYEE # SIGNATURE

    1. 1. 1.

    2. 2. 2.

    3. 3. 3.

    4. 4. 4.

    5. 5. 5.

    6. 6. 6.

    7. 7. 7.

    8. 8. 8.

    9. 9. 9.

    10. 10 10.

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    QA FORM 2-3: TRAINING ASSIGNMENT (READING)

    To: Employee No.

    From: Date:

    Please read, understand, and comply with the indicated documents.

    Document Title & Number Rev. No.

    By my signature, below I have read, understand, and will comply with all abovelisted new and/or revised procedures.

    Signature: Date:

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    QA FORM 2-4: ON-THE-JOB TRAINING RECORD

    Employee Name: Employee No.

    Work Location:

    The above named employee has performed the following job functions or tasks. It is myopinion that the employee understands what is expected, has read all associated newor revised procedures and work instructions, and can perform these tasks in asatisfactory manner.

    TASK/FUNCTION ON-THE-JOB TRAINING HOURS

    Supervisor: Date:

    Project or Facility Manager: Date:

    Other: Date:

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    Quality Assurance Manual (QAM-1)Section 3. DESIGN CONTROLRevision 3

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    SECTION 3 - DESIGN CONTROL

    A. REFERENCES

    (a) NQA-1 Section 3(b) ISO 9001-2000 Clause 7.3.1(c) 10 CFR 830.120 Criterion 6

    B. APPLICABILITY. Per the decision chart at the front of this manual.

    C. PURPOSE AND POLICY

    1. It is the policy of Philotechnics, Ltd. to ensure that the essential quality aspects ofa product or system, such as a safety, performance, and dependability areestablished during the design and development phase. This section defines therequirements and responsibilities for documenting and implementing designcontrol activities. The requirements in this section do not apply when designcontrol activities are specified by a business unit design control work instruction orproject specific procedure.

    2. This section is applicable when Philotechnics, Ltd. is solely responsible for aproduct or system design. It does not apply to existing and proven designs, nordoes it apply to designs created by subcontractors retained by Philotechnics, Ltd.When design work is subcontracted, the project or business unit acting as the

    buyer of this service has the responsibility to review and approve thesubcontractors design control measures. This review and approval process shallbe documented. Design activities performed by Philotechnics approvedsubcontractors shall be controlled in accordance with Philotechnics procedures,project specifications or approved subcontractor procedures.

    3. This section specifically does not apply to the design and development ofradiological controls survey patterns unless required by contract or if radiationlevels exceed the criteria for a very high radiation area based on current NRCdefinitions. The design and development of ordinary radiation surveys is governedby a variety of industry standard methodologies including NUREG 1757,Consolidated Decommissioning Guidelines and the Multi-Agency Radiation Surveyand Site Investigation Manual (MARSSIM) requirements.

    D. BASIC REQUIREMENTS.

    1. Designs of products or systems shall be defined, controlled, and verified.2. Procedures shall be established and maintained to control design activities.3. Design interfaces shall be identified and controlled to ensure a coordinated effort

    among participating design organizations.

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    4. Design inputs such as design bases, performance requirements, regulatory

    requirements, codes, and standards shall be identified and documented and theirselection shall be reviewed and approved.5. Design output documentation shall be reviewed and approved. Design analysis

    shall be conducted before final design release.6. Design verification shall be performed to demonstrate that design outputs meet

    design-input requirements. The extent of verification shall be based on thecomplexity of the design, importance to safety, degree of standardization, the stateof the art, and the similarity with previously proven designs.

    7. Changes to final designs shall be subject to the design controls applied to theoriginal design.

    8. Design activities performed by Philotechnics approved subcontractors shall be

    controlled in accordance with internal or approved subcontractor procedures.

    E. DESIGN RESPONSIBILITIES

    1. Design Planning. The Project Engineer or other individual responsible for designwork, shall establish a design plan that will address all design activities, includingrequired design reviews and design verification requirements. The plan shall alsoinclude, but need not be limited to, the identification of the individual(s) ordepartments responsible for the completion of the activity and the plannedcompletion date of each activity. The Project Engineer shall ensure that this planis documented, approved by the Project Manager, appropriately distributed, andupdated as the project advances.

    2. Design Inputs. The Project Engineer shall be responsible for reviewing andapproving design inputs such as sketches, drawings, design bases, performancerequirements, regulatory requirements, codes, and standards. Changes fromapproved design inputs shall be documented, approved, and controlled.

    3. Design Outputs. The Project Engineer shall develop primary and secondarydesign outputs. Design output documents shall define how the product is to bemanufactured or assembled. The Project Engineer shall also indicate thesequence of operations and inspection/test requirements. Primary design outputdocuments may be, but are not limited to drawings, specifications and proceduresand work instructions.

    4. Secondary design output documents that support the design include but are notlimited to calculations, analyses; and test results.

    5. When required, the Project Engineer shall be responsible for providing projectspecific procedures or work instructions for project designs requiring additional orunique workmanship standards, acceptance criteria, and inspection methods.

    6. Prior to issue, the Project Engineer shall present all design output documents tothe appropriate manager and the client for review and approval.

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    7. Design Review. The Project Engineer or manager shall ensure that design reviews

    are conducted at predetermined stages of the design process. A minimum of onedesign review shall be performed on any given project. The first review should beheld shortly after the beginning of the project and involve appropriate members ofthe project. Intermediate design reviews should be conducted as deemednecessary to evaluate the evolving design process and assess how well theprocess is meeting design-input requirements and schedules. Design reviewsshould consider, but need not be limited to, the following topics:

    Safety Reliability Ergonomics Serviceability Training Manufacturability

    Intended use Capability to inspect and test Environmental compatibility Operating/maintenance instructions

    8. Design Verification. Design verification shall be performed to demonstrate thatdesign output meets design input requirements. The extent of design verificationemployed is based on the complexity of the design, importance to safety, and thedegree of standardization. The project manager shall select a competentindividual who did not participate in the design process to perform and documentthe verification process. If the Project Engineer is the designing engineer or isinstrumental in the development of any design portion of the project requiringverification, then an independent designee shall perform verification. Designverification may be performed by employing any one or all of the followingmethods: performing alternate calculations; or performing qualification tests; orcomparing the new design with similar proven designs.

    9. Design Changes. When design changes are deemed necessary, the individualrequesting the change shall describe the change, provide justification, or describethe benefits of the change on a Design Change Authorization, Form QF 3-1.Design changes shall be subject to applicable design controls defined in thisprocedure.

    F. QUALITY RECORDS

    The following documents shall be processed and maintained as Quality Records inaccordance with Section 17, Quality Assurance Records.

    Design Plans Design Review Meeting Notes Design Inputs Design Verification Results Design Outputs Design Change Requests

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    QA FORM 3-1: DESIGN CHANGE AUTHORIZATIONDesign Change RequestedBy:

    Date:

    Product or Part Number and Description:

    Description of Change:

    Justification:

    Affected Documents:Document Number or Other Designation Revision Level / Date

    Impact on Other Products or Activities:

    Reviewed / ApprovedBy:

    Date:

    Distribution:

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    Quality Assurance Manual (QAM-1)Section 4. PROCUREMENT DOCUMENT CONTROLRevision 3

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    SECTION 4 - PROCUREMENT DOCUMENT CONTROL

    A. REFERENCES

    NQA-1 Section 4ISO 9001-2000 Clause 7.4.110 CFR 830.120 Criterion 7

    B. APPLICABILITY. Per the decision chart at the front of this manual.This sectionapplies to documents associated with the procurement of quality-related items andservices only, and then only when specified by the customer or when the cognizantmanager determines the need to reduce risk associated with procurement.

    C. PURPOSE AND POLICY

    Philotechnics, Ltd. shall control procurement documents relating to quality-related itemsand services in accordance with established procedures or work instructions.

    D. BASIC REQUIREMENTS

    1. Applicable design bases and other requirements necessary to assure adequatequality shall be included or referenced in documents for procurement of items andservices. To the extent necessary, procurement documents shall require

    Suppliers to have a quality assurance program consistent with the applicablerequirements of this manual.2. As deemed necessary, Philotechnics, Ltd. shall incorporate the following

    provisions in quality related procurement documents prior to issuance.

    a. A statement of the scope of work for service related procurementsb. Technical requirements shall be specified by reference to drawings,

    specifications, codes, standards, regulations, procedures, or work instructions.c. Require tests, inspections, and associated acceptance criteriad. Applicable Philotechnics, Ltd. quality assurance program requirementse. A statement allowing Philotechnics right of access to the suppliers facilityf. Required documentation to be submitted by the supplierg. The method of reporting, dispositioning, and approving non-conformancesh. The identification of appropriate spare and or replacement parts or assembliesi. The type of procurement (sole source, CPFF, T&M, FFP, etc.)

    3. Procurement documents and associated changes shall be reviewed and approvedprior to issuance. Procurement document changes shall be subject to the samedegree of control as used for the preparation of the original documents.

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    E. INSTRUCTIONS

    1. It shall be the responsibility of the requisitioner and purchase order approvalauthority to ensure that all quality related procurement documents are reviewedand approved prior to issuance to the extent dictated by the risk associated withthe purchase. Items to be considered in this review include:

    a. For services, a statement of the scope of work to be performed by the supplierb. Technical requirements such as adherence to specific drawings, specifications,

    codes, standards, regulations, and proceduresc. Identification of test, inspection, and acceptance requirements for monitoring

    and evaluating supplier performanced. Requirements to ensure Philotechnics, Ltd. quality assurance expectations willbe met and incorporated into the item or service

    e. A statement that allows Philotechnics, Ltd. personnel the right of access to thesuppliers facilities and records for the purpose of inspection or audit

    f. A list of supplier documents to be submitted to Philotechnics, Ltd. forinformation, review, or approval. A time frame for submittal shall be established

    g. When Philotechnics, Ltd. requires the supplier to maintain specific QualityAssurance records; the retention times shall be indicated

    h. Philotechnics, Ltd. requirements for reporting and approving non-conformancereport dispositions

    i. The identification of spare or replacement parts or assemblies and the methodof ordering these parts or assemblies

    j. Mandatory flow-down clauses and terms and conditions imposed byPhilotechnicss customers.

    2. The above provisions, if applicable to the procurement, shall be documented on aPurchase Requisition Form or a Purchase Order Form and processed by thePurchasing Department in accordance with established administrative purchasingprocedures.

    3. The adequacy of quality review will be assessed during routine audits.

    F. QUALITY RECORDS

    Purchase order requisitions (if utilized); and a copy of the completed purchase orderand/or changes shall be processed and maintained as Quality Records in accordancewith Section 17, Quality Assurance Records.

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    Quality Assurance Manual (QAM-1)Section 5. INSTRUCTIONS, PROCEDURES AND DRAWINGSRevision 3

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    SECTION 5 - INSTRUCTIONS, PROCEDURES AND DRAWINGS

    A. REFERENCES

    NQA-1 Section 5ISO 9001-2000 Clause 4.2, 4.2.110 CFR 830.120 Criterion 5

    B. APPLICABILITY. All projects at all times. The President may exempt specificcontracts from compliance with this procedure, using the flowchart at the beginning ofthis manual as a guide. Note: NQA-1 Section 5 states that The need for, and level ofdetail in, written procedures and instructions shall be determined based on the

    complexity of the task, the significance of the item or activity, work environment, andworker proficiency and capability (education, training, experience). Application of thissection therefore requires a graded approach and common sense.

    C. PURPOSE AND POLICY

    It is the policy of Philotechnics, Ltd. to perform quality-related work in accordance withrequirements specified in instructions, procedures, and drawings. The purpose of thissection is to define the responsibilities and minimum requirements for the preparationand control of quality related instructions, procedures, and drawings.

    D. BASIC REQUIREMENTS

    1. The underlying criteria, regardless of project size, are that:

    a. Personnel need to be instructed on work requirements,b. Whether instructions need to be documented shall be based on criteria

    described above. Whether documentation is needed and adequate will beassessed during audits based on project performance and historical informationfor similar projects.

    c. Distribution of instructions needs to be controlled.d. Training on instructions needs to be documented.

    2. Activities affecting quality shall be prescribed by and performed in accordance withdocumented instruction, procedures, or drawings of a type appropriate to thecircumstances. These documents shall include or refer to appropriate quantitativeor qualitative acceptance criteria for determining that prescribed activities havebeen satisfactorily accomplished.

    3. Formal procedures and work instructions, project/facility specific procedures andQuality Assurance Program Plans (QAPPs) shall be uniquely identified, reviewed

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    and approved prior to issuance, and have distribution controlled per Section 6 of

    this manual.4. Client provided instructions, programs, and procedures may be employed in lieu ofexisting instructions and procedures when specified by contract requirements.

    5. Instructions, procedures, drawings, QAPPs, and project/facility specific proceduresshall identify the required documentation required to support completion andacceptance of the specified task. As applicable, these documents shall alsoinclude a sequence of operations; precautions and safety requirements; requiredtools, instruments, etc.; and inspection or verification schedules.

    6. Industry standards such as A.S.T.M., A.W.S., etc., may be employed in lieu of orto supplement existing instructions and procedures.

    7. Vendor supplied instructions, procedures, and drawings shall be reviewed and

    approved by Philotechnics, Ltd. when work is subcontracted.

    E. CONTENTS AND APPROVAL FOR INSTRUCTIONS AND PROCEDURES

    1. All forms of instructions, procedures, and other quality related documents shall beorganized in a manner that will allow the user to understand and be able toaccomplish the specified task or activity in a satisfactory manner without furtherclarification. The degree of formality required in these instructions will depend onthe complexity, scope and duration of the project. Formal procedures such asthose used for Philotechnics licensed applications shall, at a minimum, contain theattributes shown in Table 5-1.

    2. Based on the nature of the prescribed activity the Author and the unit managershall decide whether or not to include the following information in the instruction orprocedure:

    a. Precautions A description of safety problems that may arise while the activityis being performed;

    b. Prerequisites Steps that should be taken before beginning the activity;c. References A list of reference material used during the development of the

    procedure or during the performance of the activity;d. Definitions - The definition of key words and/or acronyms used throughout the

    procedure; ande. Annual Review Status A review of the procedure on an annual basis.

    3. Prior to issuance, all quality related documents shall be reviewed for correctness.The Quality Assurance Manager must review customer-mandated QualityAssurance Project Plans. Other instructions, such as project manager orderspertinent to a short term project, do not require review prior to approval but will be

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    assessed during routine audits. Approval authority is determined by the business

    unit or senior manager associated with the work.4. Minor changes to instructions, procedures etc., such as, inconsequential editorialcorrections, reformatting, word replacement to enhance clarity, and redundantrequirements will only require review and approval by the appropriate managerand approver. Minor changes to a document do not require formal training.

    5. All major changes to instructions, procedures etc. other than those classified anddefined as minor changes shall be reviewed and approved by the same authoritieswho issued the original document. These individuals shall have access topertinent background data or information upon which to base their review andapproval. Major changes to a document might require formal training, and trainingshall be conducted in accordance with Section 2 of this manual.

    6. All new and revised quality related documents shall be processed, issued, andcontrolled in accordance with the requirements of Section 6, Document Control.

    F. CONTENTS AND APPROVALS FOR DRAWINGS

    1. This section pertains to formal drawings presented as final records or to controlproduction processes. It does not generally apply to working sketches, routinesurvey maps, ad hoc surveys for contaminants, or similar working documents.Individual managers can require compliance with parts or all of this section as anadditional control on a case-by-case basis.

    2. In lieu of in-house drawing preparation, managers may elect to have drawingsprepared by other individuals or engineering firms. These subcontracted sourcesmust be qualified and approved by Philotechnics in accordance with Section 7 andprocurement documents must comply with Section 4.

    3. When the customer provides the drawings as part of a purchase order or contract,the responsibility for drawing control maintenance shall rest with the customer.

    4. Drawings produced in-house or by subcontracted sources shall be processed,controlled, and maintained in accordance with this section. At a minimum,drawings shall:

    a. Be titled and numbered;b. Indicate the most current revision level;c. Provide generally accepted engineering symbols or include a legend if the

    symbols used in the drawing are uncommon or not standardized;d. List materials of construction;e. Indicate all dimensions and their tolerances;f. Provide enlargements or separate sections of details for clarification; andg. Include a note section to define or reference specific processes, procedures,

    test instructions, painting and marking/identification requirements, and specialcustomer requirements.

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    5. Formal drawings shall be:

    a. Checked by an individual other than the Originator of the drawing;b. Reviewed and approved by the Project Manager and, for production processes,

    by the Quality Assurance Manager. These reviews and approvals shall beindicated on the drawing by signature and date.

    c. Controlled in distribution using procedures described in section 6 or equivalent;d. Collected and destroyed when obsolete. A copy of obsolete drawings shall be

    marked as obsolete and maintained as a quality record per Section 17.

    6. Revisions to drawings shall be subject to the same degree of drawing

    requirements, reviews, and approvals as were performed on the original drawing.A description of the change shall be noted/dated in the drawing revision blocksection and the new revision level shall be indicated in the title block of thedrawing.

    7. Drawings furnished by Philotechnics retained subcontractors shall be reviewedand approved by the manager prior to the commencement of work.

    G. QUALITY RECORDS

    The following documents shall be processed and maintained as quality records inaccordance with Section 17, Quality Assurance Records:

    - Instructions, procedures, forms, and subsequent revisions;- Drawings and subsequent revisions;- Subcontractor generated instructions, procedures, drawings, and subsequent

    revisions; and

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    TABLE 5-1: PROCEDURE CHARACTERISTICS

    Attribute Formal Procedures Less FormalProcedures

    Revision History A cover page providing a revisionsummary with review and approvalsignatures. All instruction, procedure, andexhibit/attachment pages shall be titled,uniquely identified, numbered by page,and shall indicate revision levels startingat revision zero.

    A date of issue andsignature or initials of theoriginator. A less formalprocedure sent by e-mailwould have date and timeand identify the sender.

    Applicability A purpose or overview section providingthe document purpose and when requiredapplicability (when and when not to usethe document).

    A statement of applicability(who does this apply to),unless it applies to allproject personnel.

    Responsibilities An instruction section that defines theindividual(s) responsible for implementingthe step-by-step sequence of events tobe taken. This section shall also includeor reference appropriate quantitative orqualitative acceptance criteria fordetermining that the task or activity hasbeen satisfactory accomplished.

    Might be NA.

    Action Specify the step-by-step sequence ofevents to be taken Identify theindividuals(s) responsible forimplementing the action to be taken

    Might only require a noteto use a standardprocedure, or indicatingspecific situations todeviate from a standard

    Documentation/RecordRequirements

    An exhibit or attachment section whichdefines the documentation to becompleted in support of procedureimplementation, and aquality record section that establishes

    required documentation to be maintainedas quality assurance records

    Refer to a standard form,specify use of a hand-drawn map, and state whatretention is required.

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    Quality Assurance Manual (QAM-1)Section 6. DOCUMENT CONTROLRevision 3

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    SECTION 6 - DOCUMENT CONTROL

    A. REFERENCES

    NQA-1 Section 6ISO 9001-2000 Clause 4.2.310 CFR 830.120 Criterion 4

    B. APPLICABILITY. Per the decision chart at the front of this manual. When thismanual applies, all projects will exercise sufficient control over documents so that:

    1. current instructions are available for use and reference as needed by employees

    2. a method exists to control changes3. obsolete documents are removed from service and not used.4. personnel are informed of document changes which might affect them.

    C. PURPOSE AND POLICY

    It is the policy of Philotechnics, Ltd. to control all quality-related documents and data.This section defines the requirements and responsibilities for the preparation, issuance,and change of controlled documents. Controlled documents are instructions,procedures and drawings that specify quality requirements or prescribe activitiesaffecting quality. They are controlled to be certain that only current, approved

    procedures are used for quality-related functions.

    D. BASIC REQUIREMENT

    1. The preparation, issuance, and change of documents that specify qualityrequirements or prescribed activities affecting quality shall be controlled to assurethat correct documents are being employed. This includes formal drawings asdescribed in Section 5. Such documents, including changes thereto, shall bereviewed for adequacy and approved for release by authorized personnel.

    2. Document and data control procedures and systems shall be established andimplemented. The procedures shall provide the following:

    a. Identification of documents and data to be controlled and their distribution;b. Responsibility of individuals assigned for the preparation, review, approval, and

    issuance of documents and data; andc. Method(s) of document and data review for adequacy, completeness, and

    correctness.

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    E. INSTRUCTIONS FOR CORPORATE DOCUMENTS

    1. Controlled documents can be disseminated in one of two ways: throughdistribution of a controlled number of paper copies to specific individuals orthrough placement of a read-only document on a distributed drive for widespreadreferral and use. This procedure covers both methods.

    2. An administrative assistant or another technically qualified individual shall bedesignated as Document Control (DC) for the company and will be responsible forthe control of corporate documents. This function shall ensure that only the mostcurrent corporate documents are issued to the location where the prescribed

    activity is performed. DC shall be responsible for the following controls:

    a. Assign document identification numbers and maintain a master list of allcorporate level controlled documents. This list shall include, but need not belimited to the following:

    (1) Document title;(2) Document identification number;(3) Effective date of controlled document;(4) Current revision number;(5) Copyholder name; and(6) Date of controlled distribution. Documents issued to personnel and outside

    parties who are not affected by the document, but request copies forinformation purposes only, are released as UNCONTROLLED.Documents issued as UNCONTROLLED do not receive updates andneed not be tracked.

    b. Word process a new or revised document and mark the document as draftuntil approved.

    c. Issue a document identification number to the Originator for a new document.d. Review and incorporate all changes made to a document that is transmitted

    from the Originator. The revised document(s) shall show revision marks in themargin.

    e. Review new and revised documents to ensure that all required signatureapprovals have been obtained.

    f. Maintain and control the original document and all revisions.g. Identify and maintain vendor or subcontractor furnished corporate documents.

    Documents for business units or projects are kept by that unit or project.h. Ensure that the distribution of corporate level controlled documents and

    revisions are made by utilizing a Document Transmittal (DT), Form 6-1. An e-

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    mail is used in lieu of a Document Transmittal Sheet if the document is

    electronically distributed.

    3. Establishing a New Document

    a. Originator shall prepare the document as a draft in accordance with applicablerequirements stated in Section 5. Originator shall forward the draft document toDC and request distribution to the reviewer(s).

    b. DC shall mark the new document as a draft until approved; properly format thedocument; assign a unique document identification number; and review thedocument for grammatical errors. DC shall distribute the new document to thereviewer(s), in accordance with Section 5.

    c. Reviewer(s) shall submit comments to Originator using either a Comment Sheetor indicating the desired changes on the draft document.d. Originator shall resolve all document review comments and forward the

    changes to DC for incorporation into the new document.e. DC shall obtain all review and signature approvals in accordance with Section

    5. DC shall distribute the document to a controlled distribution utilizing the DT ore-mail.

    4. Revision of a document

    a. Employees at all levels may request a change to an existing document. Theemployee requesting the change shall discuss the change with their supervisor(Originator). If the supervisor deems the change is appropriate, the supervisorshall follow the steps below.

    b. Originator shall forward the desired changes either on a draft document or bymemorandum to DC.

    c. DC shall mark a revised document as a draft until approved; properly formatthe document; and review the document for grammatical errors. DC shalldistribute the draft document to the reviewer(s) in accordance with Section 5.

    d. Reviewer(s) shall submit comments to Originator using either Comment Sheetor indicating the desired changes on the draft document.

    e. Originator shall review and resolve all comments/changes made by theReviewer(s) and forward changes to DC for incorporation into draft document.

    f. DC shall incorporate all Originator accepted changes into revised document.DC shall obtain all review and signature approvals in accordance with Section5, Instructions, Procedures, and Drawings. DC shall distribute reviseddocument to controlled distribution utilizing the DT or notify affected persons bye-mail if the document is electronic.

    5. Corporate Controlled Distribution

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    a. The copyholder upon receipt of a controlled document (new or revised) shallcomplete the receipt acknowledgement portion of the DT and return the DT onor before the date specified. In the event that a DT cannot be completed andmailed to DC in the time frame allotted, an e-mail indicating receipt of thedocument to DC shall be accepted.

    b. Some corporate controlled documents are not distributed, but are rathermaintained in a protected file format on a corporate electronic network. Thisimproves control, reduces paperwork and makes the document more readilyaccessible for use. For a document change to an item maintained in electronicform on a network file system, DC shall update the electronically storedtemplate and provide general notification of the document change by e-mail.

    Summary of Corporate Document Control

    Function Paper Distribution Electronic DistributionNew DocumentApproval

    Document Control (DC) obtains an approval signatureon a (paper) cover sheet and files the approveddocument.

    Document Control (DC) obtains an approvalsignature on a (paper) cover sheet and files thecover sheet to represent the approved document.

    New DocumentIssue

    (DC) sends out hard copy with Document Transmittaland receives Document Transmittal back indicating thatthe controlled copy has been received.

    DC places a read-only version of the electronic fileonto a corporate distributed drive for general accessand use. DC sends an e-mail as a substitute for theDocument Transmittal form, notifying potential usersof the new document.

    UncontrolledDocument Creation(inside the

    company)

    The business unit determines whether additional copiesof procedures or forms are needed for businessoperations, such as for use as posted operating

    instructions. If additional copies are needed, thebusiness unit develops a method to track location ofthese uncontrolled copies and to change them if theparent document changes.

    The business unit determines whether paper copiesof procedures or forms are needed for businessoperations, such as for use as posted operating

    instructions. If paper copies are needed, thebusiness unit develops a method to track location ofthese uncontrolled paper copies, to change them ifthe parent document changes.

    Document ChangeApproval

    Document Control (DC) obtains an approval signatureon a (paper) cover sheet and files the approveddocument.

    Document Control (DC) obtains an approvalsignature on a (paper) cover sheet and files thecover sheet to represent the approved document.

    Document ChangeIssue

    (DC) sends out hard copy with Document Transmittaland receives Document Transmittal back indicating thatthe controlled copy has been changed and old pagesdestroyed.

    DC places a read-only revised version of theelectronic file onto a corporate distributed drive forgeneral access and use. DC sends an e-mail as asubstitute for the Document Transmittal form,notifying potential users of the change to thedocument.

    UncontrolledDocument Creation(inside thecompany)

    The business unit determines whether additional copiesof procedures or forms have been made. If additionalcopies have been made, the business unit develops amethod to track location of these uncontrolled copies

    and to change or replace them.

    The business unit determines whether paper copiesof procedures or forms have been made. If papercopies have been made, the business unit changesor replaces them.

    UncontrolledDocument Creation(outside thecompany)

    A copy of the document is made and sent to therequestor.

    A copy of the document is made and sent to therequestor.

    ComplianceVerification

    Internal audits check for controlled and uncontrolledcopies that are not current.

    Internal audits check for uncontrolled copies that arenot current.

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    F. INSTRUCTIONS FOR UNIT DOCUMENTS

    1. Managers may either use the corporate system for document control or establishtheir own system. The control system shall apply to those documents that specifyquality requirements or prescribe activities affecting quality. These documentsinclude, but need not be limited to the following:

    a. Work Instructionsb. Proceduresc. Drawingsd. Project or unit specific Quality Assurance Program Plans (QAPPs)

    2. A local system, at a minimum, shall address the following requirements:

    a. The business units method of designating controlled documents covers alldocuments which must be controlled.

    b. The business unit can identify current revisions for each controlled documentand has a history of changes.

    c. The business unit has a method of limiting and/or tracking distribution ofcontrolled documents.

    d. Documents in use have been properly reviewed and approved in accordancewith Section 5. Document changes have undergone a similar formal