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Quality Management System

Non-Smile ResourceAuthor: Document Number: Doc00-14

Effective (or ost! Date: "1 #ct 0$Document #rigin %om&any: 'R)

SM*)E +&&rove, by: enny Stevens

Revie by ei,i anes Revie ,ate $-.eb-1"SM*)E %omments: /is ,ocument is &rovi,e, as an eam&le only2 *t must be revise, to accurately reflect your lab3s s&ecific &rocessean,or s&ecific &rotocol re5uirements2 6sers are ,irecte, to countercec7 facts en consi,ering teir use in oter a&&lications2 *f you

ave any 5uestions contact SM*)E2

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Botswana-Harvard HIV

Reference Laboratory

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7re8ared By: 4a0e9 Ttle 1/nature9 2ateMunyara,8i 2 Mangen,e8a9 Quality Manager

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1.

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5&5=5 $eviews SOP prior to use5&5!5 nsures that all routine operations and activities are

documented by SOPs.5&5"5 )reates or delegates creation of documents.

4.2. 1taff55&5 $esponsible for verifying that the o/cial version of the

document is used by chec#ing the Master ist #ept by theQuality Manager.

555 $eviews and determines need for new procedures orrevision of procedures and to convey that need to their

immediate supervisor or Quality Manager.55#5 May also initiate changes and creation of documents by

completing a *ocument )hange $e'uest *)$! form,555 (t is the responsibility of the author of an SOP to include

su/cient detail that the process or procedure can befollowed by another person when needed.

4.3. Laboratory Manager5#5&5 -pproves and authori0es all technical standard operating

procedures.

4.4. Director55&5 -pproves and authori0es all standard operating procedures

5. Proceural Steps5.1. Preparing S!Ps

=5&5&5 (dentify the need for an SOP or the revision of an e%istingone by informing the supervisor or Quality Manager.

=5&55 Once the need for a particular SOP is established, it shouldbe drafted immediately.

=5&5#5 SOPs are drafted by the laboratory or supervisory sta&'uali1ed to perform the procedure. +e%t the SOP is reviewedby other sta&, where possible and then approved by theappropriate authorities. )irculation to sta& prior forreview2comment is advisable prior to ac'uiring managementapproval.

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=5&55 The SOPs should be written to describe methods orprocesses in su/cient detail so as to ensure the 'uality andintegrity of the data or procedure to be followed.

=5&5=5 "hen writing SOPs, the detail may include both proceduralre'uirements e%act instructions! and guidance informationgeneral information! on the procedure.

=5&5!5 Procedural re'uirements must be followed e%actly, whileguidance information is used to help perform the procedure3it is not a mandatory re'uirement and therefore it does nothave to be followed e%actly.

=5&5"5 Procedural re'uirements can be distinguished from

guidance elements, based on the conte%t they are used e.g.M4ST or S5- indicate the action as a proceduralre'uirement and command statements!

=5&5*5 6ollow the 755$ standard format for margins, font andfont si0e.

=5&5$5 O/cial SOP8s will have a header and footer, datedsignatures on the front page.

=5&5&%5 4se an outline format and include alpha and2or numericcharacters to indicate levels of information.

=5&5&&5The SOP2*ocuments must include:

1. 5eader and footer, detailing:a. SOP number, assigned by the Quality Manager, is

based on de1ned categoriesb. Page number in the format: Page 9 current page! of

total number of pages!c. $evision number new SOPs will be indicated by the

use of a ; and subse'uent revisions will be mar#ed e.t.c!

. &ective date date when procedure has beenapproved by all parties for use!

2. Title page (denti1er2Title

Signature lines minimally for author, Quality

Manager, aboratory Manager for technicaldocuments only!, *irector

)opy number

*istribution

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3. Table of contents4. Policy, Purpose and Scope5. Principle Technical documents!". *e1nitions if any terms need to be de1ned.! and

-bbreviations#. Personnel responsibilities$. 5ealth and safety warnings and )autions primarily for

technical SOPs!%. (nterferences primarily for technical SOPs!1&. 'uipment and SuppliesPrimarily for technical

SOPs!

11. Procedural Steps12. *ata and $ecords Management13. )o?applicable documents14. Quality -ssurance and Quality control15. $eferences1". *ocument revision history1#. -ppendi% for sta& signatures

5.2. 'u(bering Docu(ents=55&5 *ocuments are numbered se'uentially based on

assignment to a speci1c category, such as @@; A Quality Management System @@< A Sample Management

@@= A )*> ab

@@> A Biral oad ab

@@C A 5aematology ab

@@D A Serology ab

@@E A *+- P)$ ab

@@F A )linical )hemistry ab

@@G A 5ealth and Safety

@;@ A -dministration and Supplies

@;; A P7M) ab @;< A $esearch ab

Type of document3

QM A Quality Manual

P A Policies

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5S A 5ealth and Safety

P$ A Procedures

TM A Test Methods

"( A "or# (nstructions

M A 'uipment Manuals

6$ A 6orms

O( A 'uipment Operation (nstructions

T9 A Te%t boo#s

=555 The document number will appear as 755$, followed by =

digit number for category,

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the signature page will be resigned. These types ofcorrections will be traceable since the historical 1le willreHect all corrections including typographical errors.Speci1cally, the historical SOP 1le will contain both the SOPwith the correct pages as well as the pages containing theerror. The page with the error will not be removed from thehistorical 1le.

=55#5 -dditions can be made to an SOP via a clari1cation or anaddendum

=555 )lari1cations and addendums must be attached to theapplicable SOP until such a time that the SOP can be revised.

Ienerally, the revision will be incorporated during the annualreview process.

=55=5 5and written amendments are acceptable, providing allcopies of the document are clearly mar#ed, initialed anddated. %planation of the amendment should bedocumented. 6ormal revisions of these will be issued duringannual review.

=55!5 "hen the SOP is revised, the revision number is updated.$evisions, clari1cations and addenda are prepared by theappropriate personnel but must be approved bymanagement.

=55"5 -n SOP can be eliminated or made obsolete when it is nolonger applicable. Management must approve theelimination of the SOP. Two or more SOPs can beconsolidated3 in this case one SOP supercedes the other, butmanagement approval is re'uired for consolidation ofprocedures.

=55*5 The signed copy of a revised SOP must be sent to thehistorical 1le for archiving.

5.5. +sing S!Ps=5=5&5 Prior to performing a procedure for the 1rst time, the

individual must document in writing that they have read andreviewed the speci1c SOP.

=5=55 (n addition, the Sta& should review all SOPs at least once ayear to ensure that each SOP accurately describes theprocedure in use. The review will be documented in writing in

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the form of signatures. SOP review signature logs will bemaintained in the QM o/ce.

=5=5#5 -ll procedures must be performed in accordance with thewritten SOPs.

=5=55 (f a given procedure is not performed in accordance withthe pertinent SOP, then all SOP deviations must be written todocument the change in the procedure

=5=5=5 The ab Manager must be informed and must ac#nowledgein writing the occurrence of the SOP deviation and mustdetermine the e&ect, if any, the deviation may have on theintegrity of the data.

=5=5!5 -ll deviations must be 1led with the test information.

5.". ,ccess an location o- S!Ps=5!5&5 -ppropriate SOP s will be placed in 1les to be found in a

designated spot in each wor# area and shall be available toall concerned personnel. The 1les should not be located inthe supervisor8s o/ce. $emoval of an individual SOP from a1le re'uires the completion of a sign?out form located in the1le. The section supervisor approves this.

=5!55 (t is the responsibility of the Quality Manager to updateeach SOP 1le as individual SOPs are revised.

=5!5#5 Sta& is re'uired to read any revised SOP within E wor#ingdays of issuance if the SOP is applicable to their wor#.

=5!55 $eading of the updated SOP re'uires signature on the SOPreview sheet.

5.#. Docu(ent Retention=5"5&5 - historical 1le is created for each document that is

approved by management and will be maintained in thearchives by the Quality Manager.

=5"55 The historical 1le will consist of the original signeddocument and all subse'uent modi1cations thereof includingthe current document.

=5"5#5 (f a procedure is incorporated into another SOPsuperseded! a copy of the superseded version is placed inthe historical 1le of both SOPs.

5.$. !bsolete Docu(ents

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=5*5&5 Obsolete documents that a retained for reference or legalobligations are mar#ed !BS!L/and are #ept separatefrom active documents. Obsolete electronic documents areremoved from the networ# and are stored in media that areonly accessible to authori0ed personnel. -ny obsoletedocuments that need to be reactivated must be reviewed,approved and released in the same manner as newlyestablished documents.

=5*55 -t least one copy of all obsolete documents must bearchived.

5.%. lectronic Docu(ents=5$5&5 lectronic documents are writing protected and controlled

by the Quality Manager. $e'uests for revisions to electronicdocuments must be made to the Quality Manager. -llelectronic documents indicate the approval signaturesre'uired.

". Quality ,ssurance an Quality 0ontrol".1. -ll SOPs are reviewed by Quality Manager2ab Manager

with assistance from the applicable supervisor at least once ayear in order to maintain relevance.

".2. 7efore January =;stof each calendar year, a list of all SOPswhich have been revised are provided to the Quality Manager bythe supervisors. *ue to the large numbers of documents,di&erent lab sections can be scheduled for review throughoutthe year and Quality Manager #eeps documentation of this.

".3. 6or those SOPs that do not re'uire a revision,documentation attesting to that fact must be submitted to theQuality Manager who in turn initials and dates the table locatedat the end of the original SOP.

".4. -ll manuals and SOPs distributed shall have copy numberswritten in coloured pen.

".5. -ll signatures on documents shall appear in coloured pento clearly distinguish them form copies.

#. Recors#.1. *ocuments Master (nde%#.2. *ocument )hange $e'uest 6orm

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#.3. *ocument $etention Programme.#.4. SOP 5istorical 6ile#.5. *ocument $eview Schedule#.". *ocument )reation $e'uest 6orm

$. Re-erences$.1. Quality Manual. BHHRL. 0urrent ersion

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