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1

Documents and

Records

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Documents and Records - Module 16 2

Learning Objectives

At the conclusion of this session, you will be able

to: explain the difference between documents and

records;

describe the hierarchy of documents and the

role of each level; outline the contents of a quality manual;

outline the content that should be included in astandard operating procedure;

explain the important steps, or elements, of alaboratory document management system;

describe methods and tools to properly storedocuments and records

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!cenario

testing algorithm

safety manual

client test results

standard operationprocedures "!O#s$ for anapproved %&' rapid test

manufacturer test (itinserts

summary of findings fromon)site evaluation visit

report of corrective actions

temperature log "blan(form$

quality control record "blan(form$

daily maintenance log"completed$

stoc( cards and stoc( boo("completed$

*+A specimen transfer log"completed$

ou have found all these papers lying on a des(Which of these are documents and which arerecords?

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-he +uality .anagement !ystem

Organization Personnel Equipment

Purchasing

&

Inventory

Process

Control

Information

Management

Documents

&

Records

Occurrence

Managementssessment

Process

Improvement

Customer

!ervice

"acilities

&

!afety

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/hy do laboratories need to manage

documents and records0To find information

whenever it is needed!

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1ocuments and 2ecords3%ow do they differ0

Documents communicate

information viapolicies, processes,

and procedures need updating

Records capture information

on wor(sheets,forms, labels, and

charts permanent, do not

changeRECORDS

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Information is themajor product

of the laboratory

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Procedures Processes

Policies

Laboratory

Documents

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#olicies ) -he 4WT T" D"5

4A written statement of overall intentionsand directions defined by those in theorgani6ation and endorsed bymanagement5 "7L!& %!8)A9$

#olicies: tell 4what to do5 in a broad and general way

include the organi6ational mission, goals, andpurpose

serve as the framewor( for the quality system

should always be specified in the qualitymanual

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#rocesses ) -he 4"W IT PP#$%5

A 4set of interrelated or interacting activitiesthat transform inputs into outputs5 "&!O

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#rocedures ) -he 4"W T" D" IT5

!tandard operating procedures "!O#$ step)by)step instructions for performing

a single activity

=ob aid a shortened version of the !O#

does not replace the !O#

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%ierarchy of 1ocuments

&ow to do it'

&ow it happens'

&What to do'

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/hy are documents important0

essential guidelines for laboratory

quality manual

!O#s

reference materials

required by formal laboratory standards

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1ocuments are the communicators

of the quality management system(erbal instructions often are:

not heard

misunderstood

quic(ly forgotten

difficult to follow

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1ocuments are a reflection of

the laboratory>s organi6ationand its quality management

A good rule to follow is: &Do what you wrote andwrite what you are doin)*'

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?ood 1ocuments are:

clear

concise

user)friendly

explicit

accurate

up)to)date

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1ocuments for wor( processes should

be accessible to staff at the wor( site :instructions on handling incoming samples

!O#s for each test

quality control chartsand trouble)shootinginstructions

safety manualsand precautions

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The +uality ,anualis a document describin) the

-uality mana)ement system

of an or)ani.ation

/I%" 010234

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+uality .anual

communicates information serves as a framewor( or roadmap

for meeting quality management

system requirements demonstrates management

commitment to quality

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/riting a +uality .anual

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/riting a +uality .anual

5orm a %teerin) 6ommittee

%e t polic y for

07 +%

essen tials

Describe how

the related-ualityprocesses occur

Referenceprocedures

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@ey #oints: +uality .anual

only O* official version

never 4done5, always being improved

read and accepted by everyone use the best)adapted language

(ery bi) job8 but very useful

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!tandard Operating #rocedures

"!O#s$ are documents that: describe how to perform a test using

step)by)step instructions

written !O#s help ensure:

consistency

accuracy

quality

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A ?ood !O#

provides detailed, clear, and concisedirection for testing techniques

is easily understood by new

personnel

is reviewed and approved bymanagement

is updated on a regular basis

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!tandardi6ed !O# Bormat

7omputeri6ed procedure %tandardi.ation9

%eader 'ersionCchapterCreference

AuthorCreaderCvalidator 2ecipients 'ersion dateCApplication

date -ypical outline

Dpdating and storage of

different versions is easy

J Johnson,

RB m!th

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7omplete !tandardi6ed %eader

:se at the top of the first pa)e only

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2educed !tandardi6ed %eader

other pa)es of every procedure

use at the top of all other pa)es

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/hen #reparing !O#s

establishmeans forupdatin)

establishmeans forupdatin)

)ather all documents

)ather all documents

includeeach step

includeeach step

assessscientificvalidity

assessscientificvalidity

determineprocedure

to use

determineprocedure

to use

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!uggested Outline for !O#s

-itle: ame of -est #urpose: .edical use &nstructions:

#reexamination

*xamination

#ostexamination

2eferences to verify the method is established

Author>s name Approval signature"s$Einitial and date

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Avoid 1rowning in 1etailF

GA1 *HA.#L*: 4-he purpose ofthis procedure is to documentthe aforementioned activities,herin after referred to as theprescribed tas(s in terms that

preclude their execution in aninconsistent manner, wherin suchinconsistency may potentiallyresult in the prescribed tas(sdelivering a result that is not

repeatable or reproducible5F

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1o not rely solely on manufacturer

product insertsInserts do not provide specificinformation for test sites,

such as: materials required, but not in (it

specific safety requirements

external quality control requirements

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=ob Aids

shortened version of !O#s hand written or printed

visible location at testing site

useful tool to assure all testing stepsare correctly performed

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=ob Aids

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=ob Aids

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1ocument 7ontrol

assures that themost current

version is used

ensures availabilitywhen needed

or)ani.ational tool

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1ocument 7ontrol *lements

system for organi6ing, such asnumbering or coding system

approval, distribution, and revision

process master log that describes which

documents are in circulation accessibility of documents at the point

of use system for archiving

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e-uipmentservicemanuals

%"Ps

te;ts8articles8

referenceboo

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1ocuments of *xternal Origin

&nclude in the laboratory documentcontrol system: instrument service manuals

industry regulations&!O standards

references used for documentation

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umbering !ystem

need uniform numbering system do not change a current system that wor(s

one system: letter for the type of document

and then an incremented number: G8, GI,G9 for boo(s and -8, -I for official texts

number all pages of document

reference by document code, pages,location code: Goo( number I, pages 8JJ)I, on boo(shelf 8: GI,8JJ)I, G!8

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1ocument #reparation and7ontrol #rocess

PreparationPreparation

ReviewReview

IssueIssue

DistributionDistribution

RevisionRevision pprovalpproval

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&mplementing 1ocument 7ontrol

collect existing documents and records review and update

determine additional needs

develop or obtain documents, forms,wor(sheets, logboo(s, reports

involve sta(eholders

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7ommon 1ocument 7ontrol #roblems

outdated documents

too many documents are

distributed and the systemcannot be maintained

lac( of control of documentsof external and internal origin

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/hy are records essential0

%ample trac

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#atient

test reports

#atient

test reports

*+A C#- records

*+A C#- records

+ualitycontrol

data

+ualitycontrol

data

.aintenancerecords

.aintenancerecords

&nstrument

printouts

&nstrument

printouts

/or(boo(s/or(sheets

/or(boo(s/or(sheets

!ample

log boo(

or register

!ample

log boo(

or register

LaboratoryRecords

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7riticalcommunications

7riticalcommunications

7ustomerfeedbac(

7ustomerfeedbac(

Dsersurveys

Dsersurveys

7ontinuous improvement

7ontinuous improvement

*xternalauditsresults

*xternalauditsresults

&nternalauditsresults

&nternalauditsresults

#ersonnel

records

#ersonnel

records

,oreRecords

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@eep the -hings ou .ightBorgetK

disposition of rejected samples

referral of samples to anotherlaboratory

records of adverse occurrences orproblems

inventory and storage records

equipment purchase data, preventive

maintenance, and troubleshooting

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-est 2eport 7ontents &!O 88J

test identification laboratory identification patient unique

identification and location

name and address ofrequestor date and time of

collection time of receipt in lab date and time of release

of report

primary sample type results "!& units$

biological referenceintervals

interpretive comments person authori6ing

release, with signaturewhen possible

note if reporting acorrected result

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#aper !ystems

Permanence bind boo(s number pages use permanent in(

control storage

ccessibility use system that will

allow ease of access

%ecurity maintainconfidentiality

(eep safe fromenvironmental ha6ards

Traceability allow for trac(ing of a

specimen throughoutall processes

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*lectronic !ystems

permanencecomputer system maintenance, bac(ups

securityaccessconfidentiality

traceability

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-estingprocessreview

-estingprocessreview

-imebetween

assessments)audits

-imebetween

assessments)audits

2esearchpurposes

2esearchpurposes

ationallegislation

andregulation

ationallegislation

andregulation

5actors

affectin)retention

times

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!ummary1ocuments:

include written policies, processes, and procedures need to be updated and maintained

2ecords:

include information captured in processes

are permanent, do not require updating

A good document control program:

most current version used

availability and ease of access

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@ey .essages

&nformation is our product

1ocuments are essential for assuring

accuracy and consistency in thelaboratory

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!cenario

testing algorithm

safety manual

client test results





temperature log "blan(

form$ quality control record "blan(

form$



*+A sample transfer log"completed$

ou have found all these papers lying on a des(

Which of these are documents and which arerecords?

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!cenario

testing algorithm

safety manual

client test results





temperature log "blan(

form$ quality control record "blan(

form$



*+A sample transfer log"completed$

ou have found all these papers lying on a des(

Which of these are documents and which arerecords?

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+uestions0

7omments0

OrganizationPersonnel

Equipment

Purchasing

&

Inventory

Process

Control

Information

Management

Documents

&

Records

Occurrence

Managementssessment

Process

Improvement

Customer

!ervice

"acilities

&

!afety