8/18/2019 API Spec Q1 Documentation Requirements

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Documentation Requirements

4.4.2 Procedures

Verify that procedures required by the standard are established, documented, implemented, and maintained for continual suitability.

(Please complete the Identification of QMS Procedures table.)

Clause Requirement Procedure ID:Revisio

n

Finding

4.3.2.1 Competency and Training SOP 11 competence, training & awareness 14.4.3 Control o Documents SOP 6 Documents Control 1

4.4.4 !se o "#ternal Documents SOP 6 Documents Control 1

4.$ Control o Records SOP 8 Records Management 1

$.1.1 Re%ie& o Requirements SOP 1 Customer order & contract review 1

$.3Ris' (ssessment )

*anagement

SOP 3 Ris !ssessment & Contingenc"

Planning1

$.4.1 Design ) De%elopment SOP #3 Product Design & Development 1

$.$ Contingency PlanningSOP 3 Ris !ssessment & Contingenc"

Planning1

$.+ Purc,asingSOP $ Suppliers control & Outsourcing

SOP % Purcasing control1

$.+.3-eriication o Purc,ased

Products or (cti%itiesSOP % Purcasing control 1

$..1.1 Control o Production SOP % Production Control 1

$..1.2 Control o /er%icing SOP #8 'alve Servicing (

$..1.$-alidation o Processes or

Production and -alidationSOP #) 'alidation o* Processes (

$..3 Identiication ) Tracea0ility SOP #1 Product +denti*ication & racea-ilit" (

$..4 Product InspectionTeststatus

SOP 1) +nspection & testing . productrelease

1

$..$ Customersupplied Property SOP / Customer propert" 1

$..+ Preser%ation o Product SOP #( Product Preservation (

$.. Inspection ) TestingSOP 1) +nspection & testing . product

release1

$.. Pre%enti%e *aintenance SOP 16 0acilit" Maintenance 1

$.

Control o Testing

*easuring ) *onitoring

"quipment

SOP 1/ esting, measuring & monitoring

euipment1

$.5 Product ReleaseSOP 1) +nspection & testing . product

release1

$.16Control o 7onconorming

Product

SOP 1$ 2oncon*orming product &

concession(

+.2.1 Customer /atisaction SOP ## Customer complaint & satis*action 1

+.2.2 Internal (udit SOP +nternal !udit 1

+.3 (nalysis o DataSOP 1# Data anal"sis & process

measurement1

+.4.2 Correcti%e (ction SOP 13 Corrective & Preventive !ction (

+.4.3 Pre%enti%e (ction SOP 13 Corrective & Preventive !ction (

(nne# (*onogram *ar'ing (if

applicable)

SOP ) !pplication & Removal o* !P+

Monogram1