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[Company Name] Procedure Number

QSP 8.3-1
QUALITY SYST! P"#C$U" Pa%e
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Sub(ec)* $a)e I++ued
1,-,1-,.
C#NT"#L #/ N#NC#N/#"!IN0 P"#$UCT Super+ede+
None
1r2))en by*
Appro3ed by*
"e32e4-Appro3ed $a)e
1. Purpose:
The purpose of this procedure is to define the steps that [Company Name] follows to document,
segregate, evaluate, and dispose of material/product that is suspect or does not conform to
specified requirements as a means of ensuring that such material is prevented from inadvertent use
or delivery.
2. Scope:
This procedure applies to any personnel involved in or responsible for identification,
documentation, segregation when practical!, evaluation and disposition of nonconforming
materials and products, and for the notification to the functions concerned.
This procedure applies to clause ".# in $%&/T% '()*) and %ection ".# in [Company Name]+s
,-% -anual.
3. Related Procedures and Other Documentation:
.rocedure No. /escription of .rocedure
,%. *.01# Control of 2ecords
,%. ".'13 ,uality 4ailure Code 2eporting and 4eedbac5
,%. ".31' Corrective 6ction
/ocument No. /escription of /ocument
,%4 ".#1'.' Nonconforming -aterial 2eport NC-2!
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Super+ede+
None
$a)e I++ued
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Pa%e
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Procedure No.
QSP 8.3-
1
4. Procedure:
*.' 7hen nonconforming or suspect! material or product is discovered, the employee who
identified the material initiates a Nonconforming -aterial 2eport NCMR! by completing
items ' through " and the first two digits of the failure code item *! on the NCMR
Form !SF ".3#1.1.
NO$% 1: This employee is referred to as the NC-2 initiator.
NO$% 2: The failure code is used as input to the ,uality 4ailure 6nalysis and Coding
Technique ,146CT! system as a means to analy8e defect data and drive a
prioriti8ed reduction plan through corrective action. %ee !ualit& Failure Code
Reportin' and Feed(ac) !SP ".1#*.
*.0 The NC-2 initiator notifies one or more employees who have been given the
responsibility and authority to perform nonconforming product review and disposition see
NO$% 3!.
*.0.' $f the nonconforming product has left the facility, go to step *.#.
*.0.0 $f the review and appropriate disposition of the nonconforming product will occur
immediately upon its discovery, proceed to step *.3.
*.0.# &therwise, go to *.*.
NO$% 3: The above personnel are designated by the department manager as having the
5nowledge to perform nonconforming product review and disposition. These
authori+ed employees referred to as the review personnel! are responsible for
obtaining the information, other 5nowledgeable personnel, etc., necessary for
determining the appropriate disposition.
*.# The review personnel contacts the customer who received the nonconforming product,
documents the correspondence on the NCMR, and sends a copy of the NCMR to ,uality
6ssurance ,6!. .roceed to step *.3 when the department responsible is ready to
continue review.
NO$% 4: ,uality 6ssurance may initiate Correcti,e -ction !SP ".*#1 and/or ta5e other
action appropriate to the effects, or potential effects, of the nonconforming
product provided to the customer. The NCMR stays with the department
responsible for review until its disposition is determined.
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Procedure No.
QSP 8.3-
1
*.* The review personnel identifies the nonconforming product with a Noncon.ormin'
Product $a' writes the NC-2 number on the tag, moves the material to the 9:ond
6rea9 of the department in which the nonconformance was found, and sends a copy of the
NCMR to ,uality 6ssurance ,6!. .roceed to step *.3 when the department responsible
is ready to continue review.
NO$% *: The NCMR stays with the department responsible for review until its disposition
is determined.
*.3 The review personnel e;amines the nature of the nonconformance and determines
disposition by addressing the following questions in the order listed<
a! /oes the nonconformance affect product performance=
b! Can the product be >rewor5ed? to meet the specified requirements and eliminate
the detected nonconformity=
c! Can the product be >used as is? with concession=
d! Can the product be >repaired? with concession=
e! $n the case of re@ected/scrapped product, can the product be re1graded for
alternative applications=
*.3.' $f the disposition decision involves the product being >used as is? or >repaired?
with concession, then go to step *.(.
*.3.0 $f the disposition decision involves visible rewor5 on the e;terior of the product,
then go to step *.A.
*.3.# $f neither of the above apply, go to step *.".
*.( The review personnel obtains and documents concession from the parties responsible for
specifying the product requirements Customer, Bnd1user, 2egulatory body, Bngineering,
etc.!, and documents the actual condition of the product to be put into use. Co to step
*.".
NO$% /< $f the nonconforming product has already been received by the customer, product
recall is initiated.
*.A The review personnel obtains and documents approval from the customer, end1user,
regulatory body, or other body before performing any rewor5. %ee NO$% /!
*." The review personnel completes the disposition portion the last two digits of item * and
items )1'*, '( D 'A! of the NCMR, and notifies any functions that may be affected by the
nonconforming product and/or decisions on its disposition.
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$a)e I++ued
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Procedure No.
QSP 8.3-
1
*.) The review personnel compares the intended disposition 1 with regard to both product and
process specifications 1 to the currently approved plan which resulted from the .roduction
.art 6pproval .rocess.
*.).' $f there are no differences between the intended disposition and the approved plan,
then go to step *.''.
*.'E The review personnel obtains written authori8ation from the customer prior to proceeding
with disposition and identifies on the shipping container! any material shipped with
authori8ation.
NO$% 0: This requirement applies to products or services from suppliers as well as in1house
production.
NO$% ": The authori8ation shall record the quantity authori8ed and/or e;piration date.
*.'' The review personnel sends the pin5 copy of the NCMR to ,6, and ensures the blue
copy of the NCMR remains with the material until completion of the action to be ta5en,
and other copies of the NCMR are delivered to the appropriate departmentsF personnel
for initiation of the disposition action to be ta5en.
*.'0 /esignated personnel carry out the appropriate disposition action and complete line '" on
the NCMR.
*.'0.' $f the disposition does not involve repair or rewor5, then go to step *.'*.
*.'# The employee who has been given the authority and responsibility for inspection by the
department manager re1inspects the rewor5ed or repaired product in accordance with the
documented procedures / wor5 instructions.
*.'#.' $f the product does not pass re1inspection, go to step *.0.
*.'* The inspection personnel initials item number '3 on the NCMR, and ensures that the
product is returned to the activity in which the nonconformance was discovered.
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LLC
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$a)e I++ued
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Procedure No.
QSP 8.3-
1
*.'3 6fter >disposition? and >action to be ta5en? are completed, the /epartment -anager
closes out the NCMR, stores the white copy of the NCMR in the department+s
>Completed NC-2?, and forwards a copy of the closed out NCMR to ,6.
NO$% 1< 6ll >Completed NCMRs? are maintained according to Control o. Records !SP
4.2#3.
*.'( ,6 reviews the completed NCMRs on a wee5ly basis for correctness and completeness of
all information and enters the NCMR information into the ,146CT system according to
!ualit& Failure Code Reportin' and Feed(ac) !SP ".1#*.
BN/ &4 .2&CB/G2B.
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LLC
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$a)e I++ued
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Procedure No.
QSP 8.3-
1
S-MP2% NONCONFORM3N4 M-$%R3-2 R%POR$
'A! 2oute To< Bngineering
%toc5/2eceiving %erial No. HHHHH
.urchasing
&ther IIIIIIIIIIIIII /ate IIIII'!IIIII
NONCONFORM3N4 M-$%R3-2 R%POR$
NC-2!
.art No. IIIII0!IIIII 4ailure code II II *! II III
.art Name IIIII#!IIIII ,uantity IIIIII3!IIIIII
Job No. IIIII(!IIIII
%upplier/Customer Name IIIIIIIA!IIIIIII
/escription of .roblem "!IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
555555555555555555555555555555555555555555555555555555555555555555
D3SPOS3$3ON
)! 2ewor5 ,uantity IIIII$nsp. by III'3!III
'E! /eviate from %pec. Gse as is 2epair ,uantity IIIII$nsp. by IIIIIIIIII
''! %crap/2e@ect 2egrade ,uantity IIIII$nsp. by IIIIIIIIII
2equested by IIIII'0! IIIII /ate IIIII
6uthori8ed by IIIII'#! IIIII /ate IIIII
6ssigned to IIIII'*! IIIII /ate IIIII
555555555555555555555555555555555555555555555555555555555555555555
-C$3ON $O 6% $-7%N
/escription of 6ction to be Ta5en '(!
IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
6ction Completed by IIIIIII '"! IIIIIII /ate IIIIIIIIIIIIIIIIIIIII
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