Company Name
COMPANY NAMESelf Assessment Checklist (ISO/TS16949
Requirements)Department: Date:S. No.ClauseStandard RequirementWhat
to look forStatus with evidenceAction Plan, if not
OKWhoWhen24.2.3Control of Douments1. All documents to be there in
Prism with approval2. List of Records and Documents in place and
maintained3. Approved Documents in use.4. Control Copy seal in all
documents.5. Currnt Review in usage34.2.4Control of Records1.
Identification of Records2. Current revision in usage3. Retention
period (3 years)4. Storage & Retrieval of Records5. Document
Issue Control register6. Records retention sholud be in line with
statutory requirements45.3Quality Policy1. Display of Integrated
Policy at site2. Integrated policy communicated to all55.4.1Quality
ObjectivesAll the KPIs sholud be in GMR, when not reaching the goal
FCA to be prepared65.5.1Responsibility & Authority1. Updated
document in usage2. All the roles are identified and corresponding
responsibilities are mentioned75.5.1.1Responsibility for Quality1.
Personnel responsible for non conformity of the product in each
area is identified or not2. The same sholud be included in Roles
& Responsibilities85.5.3Internal CommunicationCommunication
meeting agenda and minutes to be avaliable in all the
areas.106.2.2Competence, training & Awareness1. Skill Matrix2.
Training Matrix3. Critical training identification4. Training
Plan5. Training Records6. Training Effectiveness7. Actions on
Training EffectivenessAll the above for bot GSI & Contract
employees to be avaliable6.3.1116.3.2Contingency planUpdated
Contingency plan to be made ready146.4.2Cleanliness of Premises1.
5S initiatives2. Action Plan3. Audit results177.1.1Inclusion of
customer requirements and technical specs in quality planningMust
be components of the quality plan187.1.2Acceptance criteria,
especially for attribute data samplingAcceptance criteria
defined?Approved by customer, as reqd.Zero-accept for attribute
plans197.1.3Confidentiality of customer contracted products and
projects under developmentNDA agreement with
customerConfidentiality agrement with customer's157.1.4Change
ControlProcedure for Change ControlAssessment of impactVerification
& validation methodReview w/ customer as rqrd.Applicable to
manufacturing changes217.2.1.1Customer designated special
characteristicsIdentification of special in control plan,
FMEA167.3.1.1Multidisciplinary ApproachReview of PFMEA &
Control Plan by CFTMinute of Meeting of review187.3.2.3Special
CharacteristicsIdentification of Special characteristics in Control
PlanAre all special characteristics included in control
plan?Complies with customer symbolIdentify process control
documents (drawings, FMEA, operator instructions) with
SCs377.4.3.1Process to assure the quality of purchased
productDefined methods for incoming product test or verification,
e.g.Receipt & evaluation of supplier statistical dataReceiving
inspect or testAssessments of supplier sitePart evaluation by
laboratoryOther agreed method207.5.1Contol of Production &
Service provisionAvailability of Work instructionsImplementation-
following of SOP's397.5.1.1Development of control plans for product
supplied, including customer required information and
review/updateAre control plans developed forSystem and sub-system
levelComponent or material levelPre-launch and
productionConsidering FMEADo control plans addressManufacturing
process controlsMethod for monitor of special ch.Customer required
informationReaction planEvidence of update if significant product
or process change407.5.1.2Work instructionsDocumentedAccessible at
the work stationDerived from sources such as control plan, quality
plan417.5.1.3Verification of job set-ups, according to set-up work
instructionsCheck set-up verifications atInitial run of jobMaterial
changeoverJob changeAre work instructions available?Are statistical
methods of verification used?427.5.1.4Preventive maintenance &
Predective MaintenanceIdentification of key process
equipmentResources providedPreventive maintenance planPM plan
includes:Planned activitiesPackaging and preservation of equipment,
tooling, gaugingAvailability of replacement partsDocumented
maintenance objectives217.5.1.5Production tooling;including monitor
of any outsourced workTooling ManagementResources for tool and
gauge design, fabrication, verificationTooling management program
includes:Maintenance and repairSet-up, storage, recoveryTool
change, for perishable toolsTool modification documentationTool
identification & status227.5.2Validation of processValidation
of processes for1. Change in parameters mentioned in control plan2.
New process or product477.5.2.1Requirements of 7.5.2 must apply to
all processes for production & service provisionVerify scope of
applicationVerify actual examples from products offered/jobs
running237.5.3Identification & TraceabilityIdentification &
Traceability of product & all areas487.5.3.1Requirements for
identification of product must apply through entire product
realizationDefined methodSuitable meansTraceability identification,
as rqrd247.5.5.1Storage & inventory (for product as well as
First in & First out.What is inventory management system?How is
stock rotation ensured?How is obsolete product controlled?Is
condition of stock assessed at intervals?257.6Control of Monitoring
& Measuring EquipmentCalibration & Records1. For all the
instruments that are there in Control Plan & 2. Instruments
that effect product quality527.6.2Specific requirements for records
of calibration activityMust include gauges, measuring and test
equipment including employee-owned and customer- owned
gaugesRecords must include following:Equipment
identificationRevisions after engineering chgOut-of-spec readings
as receivedAssessment of impactStatement of conformance to spec
after calibrationNotification to customer if suspect product
shipped268.1Measurement, analysis & Improvementactions on
Quality objectives deviation298.3Control of Nonconforming
productActions to eliminate the detected non conformityAuthorize
its useRecords for non conformity & its
actions688.3.1Supplemental controls over nonconforming productHow
is suspect product treated?How is unidentified product
treated?318.5.1Continual ImprovementContinual improvement projects
and their status338.5.2Corrective ActionDetermining causes of no
conformances, actions, evaluating the actions, records &
reviewing the effectiveness of the action taken. Implementation to
similar processes also.768.5.2.2Use of error-proofingExamples of
error-proofing applicationsRelated to corrective
actions778.5.2.3Corrective action impactExamples of application of
corrective action to other similar products/processesMethod of
control implemented348.5.3Preventive ActionPrevention of non
conformance, prventive actions taken, records &
effectiveness
