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3.1 Product / process audit compliance 3.5 Assess number of non conformance
3.2 Type of non conformance 3.6 Assess audit compliance
3.3 Audit completion 3.7 Check audit completion
3.4 Audit reporting
C04
LA 1. IDENTIFY ACTIVITIES OF CQI PROGRAMME (C04.01,C04.02/L4)
1.1 Process non conformity assessment material 1.9 Interpret incoming materials process
requirement non conformity assessment requirement
1.2 List of product specifications 1.10 Refer product specification
1.3 Process non conformity assessment work 1.11 Determine process non conformity
scope assessment work scope and workflow
1.4 Incoming process non conformity assessment 1.12 Determine applicable and purposes of
workflow product and process non conformity
1.5 Purposes and applicable of non-conformity procedure
assessment procedure 1.13 Determine non conformity
1.6 Product/process non conformity assessment assessment sheet and procedure
sheet 1.14 Obtain non conformity assessment
1.7 Non conformity assessment sheet and location sheet and location
1.8 Method and technique of non-conformity 1.15 Obtain method and technique of non-
assessment conformity assessment
2.1 Non conformity accuracy, specification and 2.6 Confirm non conformity accuracy,
appearance within tolerance and requirement specification and requirement
2.2 Non conformity result 2.7 Asses non conformity result
2.3 Non conformity report, format, criteria and completeness
record keeping procedure 2.8 Determine non conformity activities
2.4 Critical control points reporting, format, writing procedure and
2.5 Critical control items technique record keeping procedure
3.1 Product liability services activity and shelf 3.6 Determine product liability services
life requirement activities and product shelf life requirement
3.2 Product technical specification 3.7 Interpret product technical specifications
3.3 Product liability services activity 3.8 Determine product liability services activity
requirements workflow requirements workflow
3.4 Method of containment 3.9 Confirm method of product containment
3.5 Product liability services work activities 3.10 Ascertain product liability services work
procedure, tools and equipments, facilities activity procedure
and, work schedule 3.11Prepare applicable tools and equipments
3.12 Confirm product liability services facilities
3.13 Arrange product liability work schedule
and timeline
EVALUATE PRODUCT LIABILITY SERVICE WORK ACTIVITIES
4.1 Field failure investigation and analysis 4.7 Conduct field failure investigation and
4.2 Corrective and preventive action technique analysis
4.3 Assessment of customer satisfaction
4.8 Apply corrective and preventive action
related to product liability technique
4.4 Assessment of corrective and preventive
4.9 Asses customer satisfaction related to
action effectiveness product liability
4.5 Supplier delivery, quality performance,
4.10 Asses effectiveness of corrective and
product conformances and performance chart
preventive action
4.6 Reporting format, supplier performances
4.11 Asses supplier delivery, quality
and, record and data control procedure
performances
4.12 Review supplier product conformances
and update supplier performance chart
4.13 Record product liability services activities
LA 3. PLAN PRODUCT/PROCESS NON CONFORMANCE CONTROL REQUIREMENTS
(C06.01/L3,C06.02/L3)
4.1 Sort non conformance parts containment 4.8 Sort non conformance parts containment
4.2 Separate good and bad product/process 4.9 Separate good and bad product/process
4.3 Quarantine non conformance product/part 4.10 Quarantine non conformance
4.4 Track conformance product/part product/part
movements 4.11 Track conformance product/part
4.5 Disposition category movements
4.6 Quarantine disposition item 4.12 Determine disposition category
4.7 Disposition item specification 4.13 Quarantine disposition item
4.14 Conform disposition item specification
5.1 Product/process non conformance data 5.8 Gather product / process non conformance
collection technique data
5.2 Root cause of problem investigation 5.9 Investigate root cause of problem
technique 5.10 Initiate process deviation correction
5.3 Effective corrective action flowchart 5.11 Initiate corrective action
5.4 List of conformances status 5.12 Asses non conformances status
5.5 Non conformance product/part segregation 5.13 Asses non conformance product/part
guidelines segregation
5.6 Assessment of non conformance 5.14 Asses non conformance product/part
product/part corrective action effectiveness corrective action effectiveness
5.7 Report product/process non conformance 5.15 Record product/process non
control activities conformance control activities
Amali