Quality control process need this procedure for maintaining procedures and documents in ways that serve their intended purposes.

The document control procedure ensures that documents are created, stored, distributed, amended, revised and discarded/deleted in ways that facilitate its intended use and prevent unintended use.

Following documents come under document control procedure.

1. Quality Policy
2. Quality Objectives
3. Quality Manual
4. All laboratory created documents referenced directly or indirectly in quality manual

Any personnel of the laboratory involved with creating, preparing, approving, issuing and discarding/deleting laboratory documents need to use this procedure.

1. parent and child document: If document X refers to document Y and defines approving authority of Y, X is called parent document of Y and Y is called child document of X.
2. traceble document: If series of parent child relationship can be established between qality manual and document X, X is called traceble document.
3. Example of a traceble document: Quality Manual –> master document of biochemistry examination procedures –> Glucose examination procedure –> Internal Quality Control Procedure –> Sera reconstitution procedure –> pipetting procedure. Quality manual is the only document which donot have any parent document.
4. refering document: if document X refer to document Y but donot define approving authority of Y, X is called refering document of Y.
5. original copy of a physical document Copy of a physical document sufficiently unique to differanciate it from its photocopies. Some suggested ways of making original copy are signature of approving authority in non-black ink, stamp of approving authority in non-black-ink, non-white color of paper. Any other method of recognizing approved original copy is acceptable if it can be differentiated from its photocopies.

• For each document control activity, i.e creation,distribution,amendment,making new edition,review and deletion; make entry of type of activity,responsible personnel,date and time and decription in document control record. Such record is kept in form convenient to approving authority, conveniently in a hand-written/printed sheet attached to the original copy.
• Create:
  • Only traceble document shall be created.
  • Only Approving authority for a document shall create its child document
  • Amend parent document to contain following information
    1. unique identifier of child document
    2. current edition of the child document
    3. title of the child document
    4. approving authority for the child document
  • Approving authority for the child document assgins duty of preparing the document to personnels of the laboratory.
  • Approving authority inspect the prepared document for availability of at least following before approval.
    1. title
    2. unique identifier (on each page)
    3. the date of the current edition and/or edition number (on each page)
    4. page number to total number of pages (on each page)
    5. information/note/caution to end-user (if required) about how to use and distribute the document
    6. preparing authority (Which could be a group of persons)
    7. approving authority
    8. review period
    9. issuing authority
• Store
  • Approving authority gives original copy to issuing authority for storage and distribution.
  • Store original copy in ways that prevent its unauthorized modification.
• Distribute
  • Issuing authority can photocopy the document for distribution.
• Amend
  • Only approving authority can approve an amendment. (But others can prepare draft)
  • Hand amendment
    • When physical documents are hand amended, clearly mark, put initial and date at place of amendment to original physical documents. They may be photocopied to replace older photocopies. The revised original document is printed within a one week. Hand amendment of photocopies of physical documents shall not be done at all.
  • Print Amendment
    • Prepare amended original copy.
    • Mark “not in use” on old original copy or distroy old copy.
    • Give amended document and record of all amendments to issuing authority.
    • Ask issuing authority to withdraw all old copies by refering to distribution records.
    • Issuing authority can now distribute photocopy of amended document.
• Revise/make new edition/make new version
  • Prepare new edition of original copy with date of new edition and/or new edition number.
  • Mark “not in use” on old original copy(retain last two editions or as required by any regulation)
  • Keep record of creation of new edition.(It can be on same sheet/electronic file as amendment records)
  • Give new edition of document to issuing authority.
  • Ask issuing authority to withdraw all old edition copies by refering to distribution records.
  • Issuing authority can now distribute photocopy of new edition of the document.
• Delete
  • If a document needs to be complately removed from use follow this procedure
  • Mark “not in use” on original copy and preserve it for at least 2 years
  • Ask issuing authority to withdraw all old edition copies by refering to distribution records.
  • Amend parent document to remove reference to the deleted document

• Characteristics of required electronic documentation system
  • The laboratory or its section/department uses an electronic documentation system with following characteristics
  • The system shall have capacity to differenciate three type of users
    • ordinary user with view right (such user can use documents but can not edit them)
    • preparing authority with editing right (such user can use and edit documents but can not approve them)
    • approving authority with right to approve prepared document.
  • There shall be easily identifiable difference between prepared-but-not approved from approved documents
  • all amendment to the document shall be stored and readily available to at least the approving authority
  • last two edition (or as required by any regulation) of the document shall be stored and readily available to at least the approving authority
  • Document creation,preparation, approval, review and deletion activity shall be recorded.
• Create:
  • Only traceble document shall be created.
  • Only Approving authority for a document shall create its child document
  • Amend parent document to contain following information
    1. unique identifier of child document
    2. title of the child document
    3. approving authority for the child document
  • Approving authority for the child document assigns duty of preparing the document to personnel's of the laboratory.
  • Approving authority inspect the prepared document for availability of at least following before approval.
    1. title
    2. unique identifier (on each page if document is paged. once if document id page less(e.g HTML)
    3. the date of the current edition and/or edition number (on each page if document is paged. once if document id page less(e.g HTML)
    4. page number to total number of pages (on each page if document is paged. Document id for page less(e.g HTML)
    5. information/note/caution to end-user (if required) about how to use and distribute the document
    6. preparing authority (Which could be a group of persons)
    7. approving authority
    8. review period
    9. issuing authority(electronic-only documents have no issuing authority. They are viewed by users online)
• Delete
  • If a document needs to be completely removed from use follow this procedure
  • delete it from the system after storing it for at least two years
  • Amend parent document to remove reference to the deleted document

1. A document approved by personnel outside the laboratory is called external document.
   • example: ISO 15189
2. Such document have name, unique id, edition/version and approving authority.
   • example: ISO 15189, ISO 15189, 2007, IS/ISO
   • example: ISO 15189, ISO 15189, 2012, IS/ISO
3. Internal documents refer to it with its unique id and current edition/version and approving authority
   • example: Quality manual refers to it as ISO 15189:2007
4. External document may be physically or electronically stored in the laboratory or may be stored outside laboratory(e.g online on internet servers). Wherever required, internal document refer to such storage.
5. if any internal document needs to refer to newer version, it shall be amended with information of newer version.
   • example:
     • Quality manual refers to newer version as ISO 15189:2012
     • ISO 15189:2007 is not used because it is not referred by the quality manual.
     • As added safety, older version may be removed from circulation by approving authority of internal document referring to it.
6. if any external document is not needed its reference is removed from the referring document
   • example:
     • if ISO 15189:2007 is not used its reference in the quality manual is removed.
     • As added safety, unnecessary external documents may be removed from circulation by approving authority of internal document referring to it.