strip printer ioq

8/12/2019 Strip Printer IOQ

1/47


2/47

Installation/Operational Qualification (IOQ) Protocolfor the Strip Printer XXXX

Version

0

Page

2 of !

DO"#$%&' PP OV *S

Author's :Your signature indicates that you have completed this document and that, to the best of your knowledge, it is accurateand complete and it complies with existing XXX and regulatory requirements and adequately addresses the intended

purpose and scope.

This document requires the electronic approval of the following roles:

Subject Matter Expert:Your signature indicates, as a subject matter expert of the named application, that you have reviewed this document and agrees that it is accurate, complete, and contains the necessary degree of detail to accomplish the intended purpose.

S stem !ustodianYour signature indicates that you agree with this document, understand the areas of responsibility for your department,that this document was prepared with your knowledge and approval, and that this document complies with current Corporate !ocal XXXXXX , "nc. policies, procedures and current #ood $anufacturing practices as stated in thisdocument.

S stem "wner Your signature indicates that you agree with this document, understand the areas of responsibility for your department,that this document was prepared with your knowledge and approval, and that this document complies with current Corporate !ocal XXXXXX , "nc. policies, procedures and current #ood $anufacturing practices as stated in thisdocument.

#ualit AssuranceYour signature affirms awareness of this document and attests that the documentation and information contained hereincomplies with current Corporate !ocal XXXXXX, "nc. policies, procedures, applicable regulatory, requirements and current #ood $anufacturing practices as stated in this document.


3/47


Version

0

Page

+ of !

' ,*% O- "O&'%&'SPage

1.0 INTRODUCTION..................................................................................................................................4

1.1 PURPOSE.................................................................................................................................. 4

1.2 OBJECTIVE................................................................................................................................4

1.3 SCOPE AND QUALIFICATION APPROACH RATIONALE.........................................................4

1.4 REFERENCES........................................................................................................................... 4

1.5 RESPONSIBILITIES................................................................................................................... 5

1.6 METHODOLOGY....................................................................................................................... 5

1. SYSTEM DESCRIPTION........................................................................................................... !

2.0 INSTALLATION QUALIFICATION........................................................................................................"

2.1 D#$%&'()*)+#( V',+-+$*)+#( T' )................................................................................................. 10

2.2 E/%+ &'() *( M* #, C#& #('() V',+-+$*)+#( T' )..................................................................12

2.3 S',+* I()',-*$' DIP S +)$ ' C#(-+7%,*)+#( V',+-+$*)+#( T' ).....................................................15

2.4 U)+ +)+' V',+-+$*)+#( T' ).............................................................................................................. 1!

2.5 S *,' P*,) L+ ) V',+-+$*)+#( T' )................................................................................................ 20

3.0 INSTALLATION QUALIFICATION COMPLETION VERIFICATION......................................................22

4.0 OPERATIONAL QUALIFICATION........................................................................................................23

4.1 S)*( *, O ',*)+(7 P,#$' %,' *( T,*+(+(7 V',+-+$*)+#( T' )..................................................24

4.2 B%))#(8S +)$ 8L+7 ) V',+-+$*)+#( T' )......................................................................................... 26

4.3 P# ', L# *( R'$#9',: V',+-+$*)+#( T' )................................................................................2"

4.4 T+$;') P,+()', S: )'& V',+-+$*)+#( T' )........................................................................................31

5.0 QUALIFICATION DISPOSITION..........................................................................................................36

6.0 ATTACHMENTS................................................................................................................................... 3

A))*$ &'() N#. 1< D+ $,' *($: L#7 F#,&............................................................................................3

A))*$ &'() N#. 2< T' ) #, R'-','($' I( ),%&'() L+ )......................................................................... 3!

A))*$ &'() N#. 3< S+7(*)%,' I '()+-+$*)+#( L#7 S '')..........................................................................3"

.0 APPENDI=...........................................................................................................................................40


4/47


Version

0

Page

of !

. 0 I&' OD#"'IO&

. . P# POS%

T ' %, # ' #- ) + I( )* *)+#(8O ',*)+#(* Q%* +-+$*)+#( P,#)#$# >IOQ? + )# ') -#,) ) '#@ '$)+9' &') # # #7: ,#$' %,' *( *$$' )*($' $,+)',+* ('$' *,: )# /%* +-: S),+ P,+()', ====. T ' %, # ' + * # )# * %,' ) *) ) ' '/%+ &'() + +( )* ' # ',*)' *( ',-#,& *

' +7(' *( +( *$$#, *($' )# ) ' &*(%-*$)%,', ,'$#&&'( *)+#( ====== I($. % ', ,'/%+,'&'() *( '$+-+$*)+#( *( $GMP ,'/%+,'&'() . .

. 2 O, %"'IV%

T ' #@ '$)+9' #- ) + /%* +-+$*)+#( ,#)#$# + )# 9',+-: *( #$%&'() ) *) ) ' S),+ P,+()', ==== *

@''( ,# ', : +( )* ' *( # ',*)' +( *$$#, *($' )# ====== I($. '$+-+$*)+#( *( $GMP,'/%+,'&'() %( ', ) ' *%) #,+ *)+#( #- C *(7' C#(),# =======.

. + S"OP% &D Q# *I-I" 'IO& PP O "1 'IO& *%

T + IOQ ' ',$+ ' + $#9', +( )* *)+#( *( # ',*)+#( #- ) ' S),+ P,+()', ==== -# # +(7 ) '$#, #,*)' G #@* Q%* +): S)*( *, >GQS? C#&( Q%* +): P,*$)+$' >CQP? *( #$* ,#$' %,' .

T ' I( )* *)+#( Q%* +-+$*)+#( + 9',+-: ) ' +( )* ' : )'& $#& #('() *7*+( ) ' +7('$+-+$*)+#( *( &*(%-*$)%,+(7 ,'/%+,'&'() . T ' O ',*)+#(* Q%* +-+$*)+#( + 9',+-: ) '

-%($)+#(* $ *,*$)',+ )+$ #- ) ' : )'& *( +) $#& #('() . S: )'& -%($)+#(* +): + @' )' )' *($ * '(7' *7*+( ) ,#$' *( ' +7( $,+)',+*. T ' O ',*)+#(* Q%* +-+$*)+#( *$)+9+)+' +

'( ),*)' ) *) S),+ P,+()', ==== * ) ' $* *@+ +): #- ,+()+(7 '+7 ) #- *)*. T + ,#)#$#$#9', ) ' I( )* *)+#( *( O ',*)+#(* Q%* +-+$*)+#( *$)+9+)+' -#, ) ' S),+ P,+()', ====.

. %-% %&"%S

T + Q%* +-+$*)+#( P,#)#$# * 7'(',*)' -# # +(7 *( 7%+ ' @: $%,,'() * ,#9' S)*( *, O ',*)+(7===== *( ======

'a le &o .: eference Documents

Document '3pe 'itle ppro4al Date Source

U ', R'/%+,'&'()

F#,&

D' +7(Q%* +-+$*)+#(

R' #,)S),+ P,+()',

M*(%*


5/47


Version

0

Page

5 of !

. 0 I&' OD#"'IO& (continue6)

. 5 %SPO&SI,I*I'I%S

T ' ,' #( +@+ +): -#, ) ' /%* +-+$*)+#( *$)+9+)+' *) === ====== ,' + ' +( ) ' =======. H# '9',#) ', ' *,)&'() *9' #&' ,' #( +@+ +): * # -#, ) ' *$)+9+)+' ,' *)' )# /%* +-+$*)+#( ' '( +(7#( ) '+, ,# ' +( ,'7*, )# ) ' Q%* +-+$*)+#( P,#7,*&. R# ' *( R' #( +@+ +)+' -#, ) ' /%* +-+$*)+#(*$)+9+)+' *) === ====== *,' $#()*+(' +( =========

. 7 $%'1ODO*O89 A )' ) + @' $#( %$)' -# # +(7 ) ' ,#$' %,' ' )*@ + ' +( ) + Q%* +-+$*)+#( P,#)#$# . T ' ,' %#@)*+(' %,+(7 ) ' ' '$%)+#( #- ) ' )' ) + @' ,# ', : #$%&'()' . E*$ )' #- ) ' )' ) ,#$' %,'

+ @' +(+)+* ' *( *)' * $#& ')' . U #( ' '$%)+#( $#& ')+#( #- '*$ )' ) +) &% ) @' +( +$*)'') ', ) ' )' ) *$$' )*($' $,+)',+* *9' @''( &') #, (#) +( ) ' *$' ,#9+ ' .

C,+)+$* *,*&')', &'* %,'&'() )*;'( %,+(7 ) ' ' '$%)+#( #- ) ' Q%* +-+$*)+#( P,#)#$# &% ) @'',-#,&' % +(7 * $* +@,*)' +( ),%&'(). C# : #- ) ' $* +@,*)+#( $',)+-+$*)' &% ) @' +($ % ' +( ) '

* '( + '$)+#( #- ) + Q%* +-+$*)+#( P,#)#$# .T ' C#&&'() S'$)+#( +($ % ' +( '*$ D*)* C# '$)+#( F#,& * @' % ' )# ' $,+@' *(: * +)+#(*+(-#,&*)+#( *( 8#, ,'-','($' *)* $#( + ',' #- +& #,)*($' %,+(7 ) ' /%* +-+$*)+#( ' '$%)+#(. A *)*#@)*+(' *( #$%&'()' +( ) ' Q%* +-+$*)+#( P,#)#$# + @' ,'9+' ' @: * '$#( ', #( )# * %,'* '/%*)' #$%&'()*)+#(.

. 7 . Discrepanc3 eports I- *(: ,' % ) #@)*+(' '9+*)' -,#& ) ' *$$' )*($' $,+)',+* +) &% ) @' +&&' +*)' : $#&&%(+$*)')# ) ' +(9# 9' === ' *,)&'() *( #$%&'()' +( * D+ $,' *($: R' #,) F#,& +$ ,'&*+(* *,) #- =======. T ' D+ $,' *($: R' #,) &% ) @' ,#9+ ' +) * $ '*, ' $,+ )+#( #- ) '

+ $,' *($:89*,+*)+#( >+($ % +(7 ) ' IOQ P,#)#$# )' ) (*&' *( (%&@',? +& *$) )# ) '/%* +-+$*)+#( ' ',$+ ' ,' % )+(7 +(9' )+7*)+#( ,' # %)+#( *( 8#, * +$*@ ' $#,,'$)+9' *$)+#(. A

+ $,' *($: 7'(',*)' %,+(7 ) ' /%* +-+$*)+#( ' ',$+ ' + @' ,# ', : #$%&'()'+(9' )+7*)' *( ,' # 9' .

. 7 2 -inal Summar3 eport

U #( $#& ')+#( #- ) ' P,#)#$# ' '$%)+#( * F+(* S%&&*,: R' #,) &% ) @' 7'(',*)' *(* ,#9' . T ' F+(* S%&&*,: R' #,) + $#( + ) #- * + $% +#( #- ) ' ,' % ) #@)*+(' -#, ) '

+--','() )' ) $#()*+(' +( ) ' Q%* +-+$*)+#( P,#)#$# *( '9* %*)+#( #- ) ' ' ,' % ) *7*+( ) ) '$#,,' #( +(7 *$$' )*($' $,+)',+* + $% +#( #- ) ' + $,' *($+' '($#%()',' %,+(7 ) 'Q%* +-+$*)+#( P,#)#$# ' '$%)+#( *( ) '+, ,' '$)+9' ,' # %)+#( *( * $#($ % +#( +( ,'7*, )#) ' -+(* + # +)+#( #- ) ' ' '$%)' Q%* +-+$*)+#( P,#)#$# . T ' F+(* S%&&*,: R' #,) + @'$+,$% *)' -#, * ,#9* )# ) ' * +7(' ' *,)&'() ', #((' +( S'$)+#( 1.5 R' #( +@+ +)+' #- ) + #$%&'(). A ,#9* #- ) ' F+(* S%&&*,: R' #,) + +( +$*)' ) *) ) ' ' '$%)' Q%* +-+$*)+#(

P,#)#$# * @''( %$$' -% : $#& ')' *( ) *) *(: * +$*@ ' + $,' *($: * @''( ,# ', :,' # 9' *( ) ' * #$+*)' *)* * @''( ,'9+' ' *( * ,#9' * $#& ')' *( *$$%,*)'.


6/47


Version

0

Page

7 of !


. 7 $%'1ODO*O89 (continue6)

. 7 Data "ollection

D*)* $# '$)' *( $#&&'() &* ' + ' $#( %$)+(7 ) ' +--','() )' ) $#()*+(' +( ) +Q%* +-+$*)+#( P,#)#$# + @' ,'$#, ' #( ) ' * ,# ,+*)' *)* '') .

A '(),+' #% @' ,'$#, ' *( *)' '7+@ ' -# # +(7 ) ' SOP N#. ======== A *)* '') #% @' +7(' *( *)' @: ) ' ', #( ,'$#, +(7 ) ' *)* *( ,'9+' '

@: *(#) ', ', #( # @: +7(+(7 *--+,& ) ' *$$%,*$: *( $#& ')'(' #- ) ' *)*. A(: *$' ) *) + +()'()+#(* : '-) +( @ *(; #( *(: *)* '') @'$*% ' +) #' (#) * :

#% @' -+ ' +) N8A +(+)+* + ' *( *)' . A(: + $,' *($: )# ) ' Q%* +-+$*)+#( P,#)#$# ,#$' %,' #, #%) #- '$+-+$*)+#( ,' % ) #%

@' #$%&'()' +( * D+ $,' *($: R' #,) F#,& *( + )' #( ) ' D+ $,' *($: L#7 F#,& +( A))*$ &'() N#.1. S%&&*,+ ' -+( +(7 #- *(: ' ),*#, +(*,: $#( +)+#( #, '$+* $* ' #( ) ' * ,# ,+*)' *)*

'') '(),+' . '( ,' ) *( #(' '') #- *(: )' ) + ,'/%+,' ,' +$*)' * &*(: )+&' * ('$' *,: @%)

%(+/%' : + '()+-: '*$ #('. A '(),+' #% @' 9',+-+' @: 9+ %* ' *&+(*)+#( #- ) ' : )'&. I- 9+ %* ' *&+(*)+#( +

(#) # +@ ' % ' ) ' V',+-+$*)+#( P,#$' %,' + )' +( S'$)+#( 1.6.5 T*@ ' N#. 2 C# ' *( A@@,'9+*)+#( #( ) ' -# # +(7 *7' )# '$+-: # ) ' '(),: * 9',+-+' .

C#,,'$)+#( )# '(),+' &% ) @' $,# ' #%) +) * +(7 ' +(' ' *+(' +(+)+* + ' *( *)' .


7/47


Version

0

Page

! of !


. 7 $%'1ODO*O89 (continue6). 7 5 "o6es an6 re4iations

T ' $# ' *( *@@,'9+*)+#( ) *) *,' % ' ) ,#%7 #%) ) ' Q%* +-+$*)+#( P,#)#$# *,' + )' +( ) '-# # +(7 )*@ ' >T*@ ' N#.2? * #(7 +) ) '+, &'*(+(7 #, '-+(+)+#( e6 ,3 Date

2 0 I&S' ** 'IO& Q# *I-I" 'IO& (continue6)Q# *I-I" 'IO& (continue6)

2 + Serial Interface DIP S>itches "onfigurarion Verification 'est (continue6)

2 0 I&S' ** 'IO& Q# *I-I" 'IO& (continue6)

2 S3stem Instrumentation Verification 'est (continue6)Page ????? of ????? D ' "O**%"'IO& -O $


20/47


21/47


Version

0

Page

2. of !

()

F#

T, *(

&+))',

F#

I(+

$*)#,

F#

C

#(),#

V*9'

"ali ration "ertification is inclu6e6 in ppen6i= &um er: ???????????

&ote < M*;' $# +' #- ) + '') * ''&' ('$' *,:.

"omments:

e4ie>e6 ,3:

Date:


22/47


Version

0

Page

22 of !

DIP S>itch Set &o 2 Specification ctual

esults

cceptance"riteria met@

(9es/&o)Verifie6 ,3 / Date

2 . O--

2 2 O--

2 + O--

2 -I%*D

2 5 O--

2 7 O--

2 ! O--

2 O--

"omments:

e4ie>e6 ,3 Date


23/47


Version

0

Page

2+ of !

2 0 I&S' ** 'IO& Q# *I-I" 'IO&F (continue6)

2 #tilities Verification 'est

O e6 ,3/Date: KKKKKKKKKKKKKKKKKKKK


24/47


Version

0

Page

2 of !

2 0 I&S' ** 'IO& Q# *I-I" 'IO&C (continue6)

2 #tilities Verification 'est %lectrical (continue6)

D ' "O**%"'IO& -O $

Strip Printer XXXX G %lectrical Verification

Parameter Specifications ctual Verification$etho6

ctual esultsmet

specifications@(9es/&o)

Performe6,3/Date

V# )*7'R'/%' )' 110 VAC 10

A& ',*7' FIELD

F,'/%'($: 60 H 5

66itional information

R'-','($'8 T' ) I( ),%&'()e6 3: Date:


33/47


Version

0

Page

++ of !

0 OP% 'IO& * Q# *I-I" 'IO& ("ontinue6)

2 ,uttons/S>itch/*ights Verification 'est (continue6)

D ' "O**%"'IO& -O $

,utton /S>itch /*ights

DescriptionStep Proce6ure %=pecte6 esults ctual esult

ctual resultsmet e=pecte6results@ (9/&)

Performe6,3/Date

PAPER OUTL+7 )

*(

ERROR L+7 )

1

T%,( ) ' # ', +)$ )# ) 'ON # +)+#(. P,' ) '

PAPER FEED @%))#( %()+) ' * ', ,# + ('*, ) ' '( .

R' PAPER OUT +7 ) ++ %&+(*)' .

R' PAPER OUT+7 ) *

KKKKKKKKKKKK

2T%,( ) ' # ', +)$ )# ) 'ON # +)+#( +) (# * ', +() ' )+$;') ,+()',.

R' PAPER OUT *( R'ERROR +7 ) *,' + %&+(*)' .

R' PAPER OUT*( R' ERROR

+7 ) ',' KKKKKKKKKKKKKKK.

"omments:

e4ie>e6 3: Date:


34/47


Version

0

Page

+ of !


+ Po>er *oss an6 eco4er3 Verification 'est

O


35/47


Version

0

Page

+5 of !


+ Po>er *oss an6 eco4er3 Verification 'est (continue6)

D ' "O**%"'IO& -O $

Strip Printer XXXX

Operation Proce6ure 'est %=pecte6 esponse ctual esultsctual esults met

%=pecte6esponse@ (9/&)

Performe6,3/Date

P# ', L#*(

R'$#9',:

D%,+(7 (#,&* # ',*)+#(+()',,% ) ) ' # ', % :)# ) ' '/%+ &'(). *+) *)

'* ) 5 &+(%)' *(,' )#,' ) ' # ', % :)# ) ' '/%+ &'().D#$%&'() ) ' )*,) *('( )+&' #- ) ' )' ).

A-)', # ', + # ) ) ': )'& %) #-- *( ) ',#$' )# . T '( (#

-%,) ', # ',*)+#( #%@' # +@ '. A-)',,' )#,+(7 ) ' # ', ) '

: )'& &% ) @' *@ ' )#)*,) # ',*)+#(.

S)*,) T+&'< KKKKKKKKKKKKKK

A-)', # ', + # ) ) ' : )'&

KKKKKKKKKKKK *( ) ' ,#$'

KKKKKKKKKKKK. T '( -%,) ',

# ',*)+#( KKKKKKKKKKKK # +@ '.

A-)', ,' )#,+(7 ) ' # ', ) '

: )'& KKKKKKKKKKKK *@ ' )# )*,)

# ',*)+#(.

E( T+&'< KKKKKKKKKKKKKK

"omments:

e4ie>e6 3: Date:


36/47


Version

0

Page

+7 of !


'icAet Printer S3stem Verification 'est

O


37/47


Version

0

Page

+! of !


'icAet Printer S3stem Verification 'est (continue6)

D ' "O**%"'IO& -O $

Steps 'est Proce6ure %=pecte6 esponse ctual esultsVerification

$etho6

ctual esults met>ith %=pecte6

esponse@ 9es/&o

Performe6,3/Date:

%pson Heighing 'erminal I&D570

. S +)$ ) ' +7+)* $* ' *() ' )+$;') P,+()', ON .T ' @* *($' *( ) ' ,+()','(',7+ '.

T ' @* *($' *( ) ',+()', KKKK

'(',7+ ' .

2 P,' ',# ;': +() ' +7+)* $* ' $,''(.

T ' $* ' ,' ') )# 0.000 ;7. T ' $* ' KKKKKKKK )# 0.000 ;7

+ P *$' *( '& ): $#()*+(', #() ' D+7+)* S$* '.

T ' '& ): $#()*+(', '+7 )+ + *:' #( ) ' +7+)*

$* ' +( +$*)#,. D#$%&'()'+7 ).

E& ): C#()*+(',D+ *:' '+7 )*) +7+)* $* '$,''(? + ,' ') )# 0.000 ;7.

*( N') :&@# * '*, +($,''(.

D+ *: >*) +7+)*$* ' $,''(? KKKK

)# 0.000 ;7 *( N'):&@# KKKKKKK +(

) ' $,''(.

"omments:

e4ie>e6 3: Date:


38/47


Version

0

Page

+ of !

0 OP% 'IO& * Q# *I-I" 'IO& (continue6)


D ' "O**%"'IO& -O $

Steps Proce6ure %=pecte6 esponse ctual esults Verification $etho6

ctual esultsmet >ith%=pecte6esponse@ 9es/&o

Performe,3/Date:

%pson Heighing 'erminal I&D570

5 F+ ) ' $#()*+(',.

T ' (') '+7 ) + + *:'#( ) ' +7+)* $* '+( +$*)#,. D#$%&'()

'+7 ).

N') '+7 ) D+ *:' *) +7+)*$* ' $,''(? KKKK

)# 0.000 ;7 *( N'):&@# KKKKKKK +(

) ' $,''(.

"omments:

e4ie>e6 3: Date:


40/47


Version

0

Page

0 of !



D ' "O**%"'IO& -O $


ctual esults

met >ith%=pecte6esponse@ 9es/&o

Performe,3/Date:

%pson Heighing 'erminal 5+0

5 F+ ) ' $#()*+(',.

T ' (') '+7 ) + + *:'#( ) ' +7+)* $* '+( +$*)#,. D#$%&'()

'+7 ).

N') '+7 ) D+ *:' ith %=pecte6

esponse@ 9es/&o

Performe6,3/Date:

%pson Heighing 'erminal *9&X

. S +)$ ) ' +7+)* $* ' *() ' )+$;') P,+()', ON .T ' @* *($' *( ) ' ,+()','(',7+ '.

T ' @* *($' *( ) ',+()', KKKK

'(',7+ ' .

2P,' ',# ;': +() ' +7+)* $* ' $,''(.

T ' $* ' ,' ') )# 0.000 ;7. T ' $* ' KKKKKKKK )# 0.000 ;7

+ P *$' *( '& ): $#()*+(', #() ' D+7+)* S$* '.

T ' '& ): $#()*+(', '+7 )+ + *:' #( ) ' +7+)*

$* ' +( +$*)#,. D#$%&'()

'+7 ).

E& ): C#()*+(',D+ *:' '+7 )*) +7+)* $* '$,''(? + ,' ') )# 0.000 ;7.

*( N') :&@# * '*, +($,''(.

D+ *: >*) +7+)*$* ' $,''(? KKKK

)# 0.000 ;7 *( N'):&@# KKKKKKK +(

) ' $,''(.

"omments:

e4ie>e6 3: Date:


42/47


Version

0

Page

2 of !



D ' "O**%"'IO& -O $


ctual esults

met >ith%=pecte6esponse@ 9es/&o

Performe,3/Date:

%pson Heighing 'erminal *9&X

5 F+ ) ' $#()*+(',.

T ' (') '+7 ) + + *:'#( ) ' +7+)* $* '+( +$*)#,. D#$%&'()

'+7 ).

N') '+7 ) D+ *:' ',' * +$*@ '? ) ' C Q' *,)&'() + ,'$#&&'( +(7 ) *)#) ', ) *( ) ' * ,#9* *7' ? * -+ +() ' *)* ,'/%' )' @' # .

Print &ame Signature Initials Department or "ompan3


47/47


Version

0

Page

! of !

! 0 PP%&DIX

ppen6i= &um er Description