Presentation Docu Control TQM Cell

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    Document & Data ControlDocument & Data Control

    Presented by:TQM Promotion Cell

    Knits Division

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    OutlineOutline

    Definition, Hierarchy, Types, etc. of Documents

    Why do we need documents? What is a good

    document?

    Why are Records essential? Examples of Records.

    Advantages of Document Control

    Elements of Document Control

    Essential Features in a Document

    Implementation Steps for Documentation Control

    SOP for Documentation Control at Knits Business

    Division

    Definition, Hierarchy, Types, etc. of Documents

    Why do we need documents? What is a good

    document?

    Why are Records essential? Examples of Records.

    Advantages of Document Control

    Elements of Document Control

    Essential Features in a Document

    Implementation Steps for Documentation Control

    SOP for Documentation Control at Knits Business

    Division

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    DefinitionsDefinitions

    Documents: written policies, processdescriptions, procedures, and blank forms

    Used to communicate information

    Records: worksheets, forms, charts, labels,

    Used to capture information, activities, orresults when performing a procedure

    May be paper or electronic

    Documents: written policies, processdescriptions, procedures, and blank forms

    Used to communicate information

    Records: worksheets, forms, charts, labels,

    Used to capture information, activities, orresults when performing a procedure

    May be paper or electronic

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    Hierarchy of DocumentsHierarchy of Documents

    PoliciesPolicies

    ProcessesProcesses

    Procedures /Procedures /

    Work InstructionsWork Instructions

    what to do

    how it happens

    how to do it -

    (SOPs)

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    PoliciesPolicies

    The WHAT TODO

    Statements of the organization's intent

    Framework for the organizations QualityManual / Pricing Policy, etc.

    The WHAT TODO

    Statements of the organization's intent

    Framework for the organizations QualityManual / Pricing Policy, etc.

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    ProcessesProcesses

    The HOW IT HAPPENS

    Describes the steps involved to achieve

    organizational objectives & carry outquality policies.

    Usually represented in flow charts

    Involves a series of steps, usuallyoccurring over a period of time

    The HOW IT HAPPENS

    Describes the steps involved to achieve

    organizational objectives & carry outquality policies.

    Usually represented in flow charts

    Involves a series of steps, usuallyoccurring over a period of time

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    SOPs / Work InstructionsSOPs / Work Instructions

    The HOW TODO IT

    The step-by-step instructions for

    performing a single activity

    The HOW TODO IT

    The step-by-step instructions for

    performing a single activity

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    Why Do We Need Documents?Why Do We Need Documents?

    Policies - communicate to customers &to employees

    Standardising Processes & WorkMethods

    Induction and other training

    Instructions / Controlls

    Policies - communicate to customers &to employees

    Standardising Processes & WorkMethods

    Induction and other training

    Instructions / Controlls

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    Good Documents Are:Good Documents Are:

    Clear

    Concise

    User friendly

    Clear

    Concise

    User friendly

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    Avoid Drowning in Detail..Avoid Drowning in Detail..

    BAD EXAMPLE: The purpose of thisprocedure is to document the

    aforementioned activities, hereinafterreferred to as the prescribed tasks interms that preclude their execution in aninconsistent manner, wherein suchinconsistency may potentially result in theprescribed tasks delivering a result that isnot repeatable or reproducible

    BAD EXAMPLE: The purpose of thisprocedure is to document the

    aforementioned activities, hereinafterreferred to as the prescribed tasks interms that preclude their execution in aninconsistent manner, wherein suchinconsistency may potentially result in theprescribed tasks delivering a result that isnot repeatable or reproducible

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    And Poorly Written ProceduresAnd Poorly Written Procedures

    Why use ten words when one will do?

    The items hereinunder referenced in

    some cases fell excessively outsidenormal parameters.

    The procedures contained herein are

    applicable to all operations in thefollowing departments within theirfunctional ambit

    Why use ten words when one will do?

    The items hereinunder referenced in

    some cases fell excessively outsidenormal parameters.

    The procedures contained herein are

    applicable to all operations in thefollowing departments within theirfunctional ambit

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    RecordsRecords

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    Why are Records Essential?Why are Records Essential?

    For continuous monitoring

    ForOrder tracking throughout process

    To identify failures in equipment

    To revisit information; reference

    For use as a management tool

    For continuous monitoring

    ForOrder tracking throughout process

    To identify failures in equipment

    To revisit information; reference

    For use as a management tool

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    Examples:Examples:

    Inspection Reports

    Production Reports

    Abnormality Handling Reports Complaint Handling Reports

    Machine History Cards

    Personnel Records Sales Records

    Audit Reports

    Inspection Reports

    Production Reports

    Abnormality Handling Reports Complaint Handling Reports

    Machine History Cards

    Personnel Records Sales Records

    Audit Reports

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    Document / Record ControlDocument / Record Control

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    Document ControlDocument Control

    Advantages:

    Assures that the most current version is used

    Ensures availability when needed Standardize the Processes & Work Methods

    Facilitate improvement and to track the

    changes made in Processes / SOPs Ensure we hold on to the gains made through

    small improvements

    Advantages:

    Assures that the most current version is used

    Ensures availability when needed Standardize the Processes & Work Methods

    Facilitate improvement and to track the

    changes made in Processes / SOPs Ensure we hold on to the gains made through

    small improvements

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    Document Control ElementsDocument Control Elements

    A system for formatting and maintainingdocuments Uniform format

    Legible and identifiable Approval, distribution, and revision process

    Reviewed and updated Master log Availability

    Relevant versions at point of use Archive

    A system for formatting and maintainingdocuments Uniform format

    Legible and identifiable Approval, distribution, and revision process

    Reviewed and updated Master log Availability

    Relevant versions at point of use Archive

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    Documents of ExternalOriginDocuments of ExternalOrigin

    Include in your document control system:

    Machinery service manuals Industry regulations

    ISOstandards

    Include in your document control system:

    Machinery service manuals Industry regulations

    ISOstandards

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    Implementation StepsImplementation Steps

    Collect existing documents and records

    Review and update

    Determine additional needs

    Develop or obtain

    Documents, forms, worksheets, logbooks,reports

    Involve stakeholders Notify staff of change / new document

    Old documents replaced by new

    Master list of documents u dated

    Collect existing documents and records

    Review and update

    Determine additional needs

    Develop or obtain

    Documents, forms, worksheets, logbooks,reports

    Involve stakeholders Notify staff of change / new document

    Old documents replaced by new

    Master list of documents u dated

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    Summary: Document Preparation and

    Control Process

    Summary: Document Preparation and

    Control Process

    Approval

    Issue /

    DistributionReview

    Revision

    PreparationPreparation

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    Document ReviewDocument Review

    Regular review

    by same function as authorized

    Identification of alterations

    if possible

    Regular review

    by same function as authorized

    Identification of alterations

    if possible

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    Practices that could kill

    Document Control

    Practices that could kill

    Document Control Photocopies

    Notices on walls

    if uncontrolled

    Handwritten amendments

    if unauthorised

    Photocopies

    Notices on walls

    if uncontrolled

    Handwritten amendments

    if unauthorised