TITLE
DEPTT/
SECTION
MATERIALS
MANAGEMENT
SUPPLIER EVALUATION AND
PERFORMANCE MONITORING
RELATED ISO 9001 CLAUSE
4.6.2
PREPARED BY
REVIEWED BY
DOCUMENT #.
RP-SP/F-07
ISSUE #.
01
ISSUE DATE
11-10-2012
PAGE #.
1 of 5
OPERATIONAL/ FUNCTIONAL
APPROVAL BY
ADMINISTRATIVE APPROVAL BY
1.0 PURPOSE
1.1 To devise a system, establish a procedure, assign responsibilities and provide instructions for
1- Initiation of supplier evaluation.
2- Evaluation of existing and new suppliers.
3- Initiating actions on identification of out-of-specification product / supply form supplier.
4- Taking appropriate corrective actions against deviations originated from their supplies.
5- Monitoring their performance and re-evaluating them.
2.0. SCOPE
2.1 The product is applicable for
2.1.1 All those suppliers who are supplying those products and service which can directly or indirectly affect the Quality of
Ray Pharmaceutical products and services.
3.0. ABBREVIATION
3.1 OMM
3.2 MA
3.3 QAM
3.4 ME
3.5 CEO
3.6. NSM
3.7. MC
=
=
=
=
=
=
=
Officer Materials Management
Manager Accounts
Quality Assurance Manager
Maintenance Engineer
Chief Executing Officer
National Sales Manger
Manager Costing and Budgeting
4.0 RESPONSIBILITY
4.1 The table below list the responsibilities related to suppliers evaluation
TYPE
Products
ITEM
EVALUATION
ACTIVITY / REEVALUATION ACTIVITY
EXECTION
APPROVAL /
DELETION
RECORDS
Raw Materials (Imported)
Imported Raw Materials (Purchased Locally)
Locally Manufactured Raw Materials
Packaging Materials (Imported)
Imported Packaging materials (Purchased Locally)
Locally manufactured Packaging materials
Laboratory Reagents
Production assemblies e.g. filters, sieves, dies purchases etc.
Machines, Machine parts, Testing Equipments
Asst. MM / MC
MA / MC
MA / MC
Asst. MM / MC
MA / MC
MA / MC
MA / QAM
MA / PM
MA/QAM
MD
MD
MD
MD
MD
MD
QAM
ME / PM
QAM/ME/PM
Asst. MM
MA
MA
Asst. MM
MA
MA
MA
MA
MA
TITLE
DEPTT/
SECTION
MATERIALS
MANAGEMENT
SUPPLIER EVALUATION AND
PERFORMANCE MONITORING
RELATED ISO 9001 CLAUSE
4.6.2
TYPE
Services
DOCUMENT #.
RP-SP/F-07
ISSUE #.
01
ISSUE DATE
11-10-2012
PAGE #.
2 of 5
ITEM
EVALUATION
ACTIVITY / REEVALUATION ACTIVITY
EXECUTION
APPROVAL /
DELETION
RECORDS
Contract Manufacturing
Distribution
Clearing Forwarding, Custom Clearance
Calibration
Training
Consultancy
Equipment Maintenance
ME / QAM
NSM
Asst. MM
ME / QAM
ME
ME
ME
MD
MD
MD
QAM / ME
MD
MD
MD
ME/DDC
NSM
Asst. MM
ME/DDC
ME/DDC
ME/DDC
ME/DDC
5.0. PROCEDURE
5.1 INITIATION OF EVALUATION ACTIVITY
1- Whenever a potential supplier approaches the Ray Pharmaceutical or Ray Pharmaceutical decides to purchase product /
service form a particular supplier, the designations responsible for supplier evaluation takes the verbal concurrence from
designations responsible for the approval of that supplier of that particular item.
2- For existing supplier the designations responsible for the approval of that supplier of that particular item.
3- The supplier evaluation form is faxed / mailed to supplier after filling the section A of the form.
5.2 EVALUATION OF EXISTING SUPPLIERS
5.2.1 For existing suppliers, the evaluators, evaluates them on the basis of their past performance w.r.t.
1- Quality Record / Service delivered.
2- On-time delivery.
3- Quantity i.e. their ability to provide ordered quantity.
4- Reputation.
5- Capability to meet urgencies.
6- Quality System Practices.
7- After Sales Service (where applicable).
5.3 EVALUATION OF NEW SUPPLIERS
5.3.1 For new suppliers, the evaluators evaluates them on the basis of following
1- Company profile.
2- Financial Status.
3- Risk Calculation w.r.t. Ray Pharmaceutical. I.e. additional controls that Ray Pharmaceutical has to acquire.
4- Cost competitiveness.
5- Numbers of years in the business with pharmaceutical companies.
6- Ability to safeguard intellectual properly.
7- Sample test results.
8- Results obtained during the trial production run.
TITLE
DEPTT/
SECTION
MATERIALS
MANAGEMENT
SUPPLIER EVALUATION AND
PERFORMANCE MONITORING
RELATED ISO 9001 CLAUSE
4.6.2
DOCUMENT #.
RP-SP/F-07
ISSUE #.
01
ISSUE DATE
11-10-2012
PAGE #.
3 of 5
9- Major customers.
10- Experience of other users using the same product or different product form the same company.
11- Production capabilities.
12- Major inspection / testing equipments.
13- Quality System practices.
14- System of after sales service and availability of spare parts (where applicable).
15- Level of skilled / trained personnel.
16- Stage of inspection and testing.
17- Supplier facility visit report.
5.3.2 Where applicable and feasible, the following activities are performed during the evaluation process
a) Facility of the supplier is visited.
b) Sample is tested / inspected or use for trail purpose to evaluate the performance.
c) Information is seeked regarding the performance of the material and supplier in other companies by the evaluator
during the evaluation process.
5.3.3 The evaluator documents his findings during the facility visit on supplier facility report..
5.3.4 After the evaluation for has been received for the supplier, the evaluator completes the section C of the form and
attach the supplier facility report (where applicable) with the evaluation form.
5.3.5 The supplier evaluation form and other supporting documents (if any) like. Company profile, Supplier Facility Visit
report, results of trial sample / production run etc. are submitted to the designations responsible e for supplier approval.
5.3.6 For new suppliers, the evaluator gives their recommendations / comments based on the evaluation and then forwards
for onward approval.
5.3.7 The designations responsible for approval / deletion decides whether to approve the supplier or not and the reevaluation frequency in case of approval.
5.3.8 If the supplier is not approved at this stage, the subsequent activities will not be carried out.
5.3.9 After the supplier has been approved, the designations responsible for approval, returns the evaluation form to
designations responsible for evaluation.
5.3.10 The designations responsible for evaluation files the evaluation form in a separate supplier file and update the
approved supplier list.
5.4 ACTIONS ON SUPPLIER RELATED NON-CONFORMITIES
5.4.1 Whenever any deviation / out-of-specification product / non-conformance related to product / service is NCR identified
by any individual during any stage of receiving, manufacturing, packaging and delivery a is initiated and the deviation /
non-conformity is documented on NCR.
5.4.2
After the disposition of deviation / non-conformity, a copy of NCR is submitted by designations taking the disposition
5.4.3
action to designations responsible for receiving inspection for expanded sampling and inspection / testing.
In case of critical / consistent minor deviations / non-conformities from the same supplier, the designations / areas
affected by those deviations raises the CAR.
TITLE
DEPTT/
SECTION
MATERIALS
MANAGEMENT
SUPPLIER EVALUATION AND
PERFORMANCE MONITORING
RELATED ISO 9001 CLAUSE
4.6.2
DOCUMENT #.
RP-SP/F-07
ISSUE #.
01
ISSUE DATE
11-10-2012
PAGE #.
4 of 5
5.4.4
5.4.5
5.4.6
The CAR is send to MR for action.
The MR initiates the investigation for causes of deviations / non-conformance as per procedure.
The MR sends a copy of CAR to the respective evaluator / purchaser / area incharge to initiate the investigation and to
propose a corrective action (if required).
5.4.7 If the cause of deviations / non-conformance is identified to be related to supplier the MR sends a copy of CAR to
designations responsible for evaluation in order to take corrective actions.
5.4.8 The evaluator can either propose the corrective action or seeks the corrective actions from the supplier (in written).
5.4.9 The evaluator communicates to the supplier about the proposed corrective action.
5.4.10 If the product / service form the same supplier is received just after the deviation / non-conformity is identified the
evaluator / area incharge / area responsible for receiving inspection ensures through checking / monitoring of the
product / service.
6.0
SUPPLIERS PERFORMANCE MONITORING
6.1. Warehouse Officer performs the supplier performance monitoring for suppliers of raw and packing materials, on order to
Order basis.
6.2. For Quality Parameters 2nd Warehouse Officer calculate the % points after all the material has been consumed and no
NCR related to quality defect / efficiency has been raised against the purchase order requirements and assign the
Achieved % points using the table below (Table-1).
6.3. Whenever stores / warehouse receives the supply of raw and packing materials they calculate the % points for quality and
Delivery time by comparing the actual status.
6.4. At the end of each quarter, Warehouse Officer calculate the overall % points and assign the ranking grade to supplier
as per table-2.
TABLE 1
QUALITY
POINT
S IN %
QUANTITY
POINTS IN %
DELIVERY
POINTS IN
%
Wrong Product / Grade
20%
100%
Earlier or on time
100%
Damaged Container / bags
50%
Complete order or
Excess (<5%)
< 5 1% of ordered
Delay by 1-5 days
Unsealed Container / bags
50%
< 6 10% of ordered
90 99%
(2% / % of order)
80 89%
(2% / % of order)
90 99%
(2% / day)
80 89%
(2% / day)
Delay by 6-10 days
TITLE
DEPTT/
SECTION
MATERIALS
MANAGEMENT
SUPPLIER EVALUATION AND
PERFORMANCE MONITORING
RELATED ISO 9001 CLAUSE
4.6.2
DOCUMENT #.
RP-SP/F-07
ISSUE #.
01
ISSUE DATE
11-10-2012
PAGE #.
5 of 5
TABLE 1
QUALITY
POINT
S IN %
QUANTITY
POINTS IN %
DELIVERY
POINTS IN
%
Wrong labeling
5%
<11 15% of ordered
Delay by 11-15 days
Expired Material
20%
< 15 20% of ordered
Material with <75% shelf life
10%
< 25 30% of ordered
Test failure in minor parameter
10%
----
Test Failure in major parameter
20%
----
70 79%
(2% / % of order)
60 69%
(2% / % of order)
50 59%
(2% / % of order)
40 59%
(2% / % of order)
0
> one month
70 79%
(2% / day)
60 69%
(2% / day)
50 59%
(2% / day)
40 59%
(2% / day)
0
Contaminated Product
20%
----
----
----
----
Product from different
manufacturer
10%
----
----
----
----
Delay by 16-20 days
Delay by 21-25 days
Delay by 26-30 days
TABLE 1
RANKING TABLE
95 100 %
80 94 %
70 79 %
Below 70 %
6.4.1
6.4.2
Excellent Supplier
Good Supplier
Average Supplier
poor Supplier
A Grade
B Grade
C Grade
D Grade
The evaluator sends the performance evaluation to ME who presents the status in System Review Meeting.
The designations identified under supplier approval / deletion decides whether to continue with the supplier or not.
7.0 RELATED DOCUMENTS
7.1 Suppliers Evaluation (RP-F/F-26)
7.2 Approved Supplier List (RP-F/F-27)
7.3 Suppliers Facility Visit Report (RP-F/F-28)
7.4 Supplier Performance Monitoring (RP-F/F-29)
