presentation of sampling , testing ,release and rejection of Raw materials

SAMPLING, TESTING AND

RELEASE / REJECTION OF

RAW MATERIALS

Presented byMalangsha

[email protected]

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SAMPLING, TESTING AND

RELEASE / REJECTION OF

RAW MATERIALS

Presented byMalangsha

[email protected]

Quality control shall receive "Material Received Report (MRR) from

Warehouse as an intimation for raw material sampling.

Upon receipt, sampling Executive shall verify the details on the

MRR and supplier COA.

Sampling Executive shall enter the details in the Raw Material

Inward Record as per the MRR and assigns an Analytical Reference

Number as per SOP.

Sampling I analysis priority shall be decided upon the requirement of

material and production plan, in case of multi MRR receipt.

Executive-QC shall prepare the required number of labels (i.e.,

"Sample for analysis" and"Sampled") as defined in the below sampling

plan.

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Quality control shall receive "Material Received Report (MRR) from

Warehouse as an intimation for raw material sampling.

Upon receipt, sampling Executive shall verify the details on the

MRR and supplier COA.


Inward Record as per the MRR and assigns an Analytical Reference

Number as per SOP.

Sampling I analysis priority shall be decided upon the requirement of

material and production plan, in case of multi MRR receipt.

Executive-QC shall prepare the required number of labels (i.e.,

"Sample for analysis" and"Sampled") as defined in the below sampling

plan.

Sampling plan

1 to 5 All

6 to 10 6

11 to 20 7

21 to 56 8

More than 56 --./n+ 1*

If the decimal in --./n value is less than 5, it shall be rounded to the

lowest value, if it is more than or equal to 5, it shall be rounded to

the highest value.

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Sampling plan

1 to 5 All

6 to 10 6

11 to 20 7

21 to 56 8

More than 56 --./n+ 1*

If the decimal in --./n value is less than 5, it shall be rounded to the

lowest value, if it is more than or equal to 5, it shall be rounded to

the highest value.

Note: For the new vendor first three consignments of starting

raw materials, composite sample shall be prepared from all

the containers (100% sampling), irrespective of the sampling

plan.

Executive-QC shall carry self-sealed polyethylene bags,glass bottles, cleaned sampling devices (such as SS Scoop,thief sampler/glass sampler), prepared labels and samplingrecord to proceed for sampling. Sampling Executive shall verify the physical condition,consignment details and "Under Test" label of the containersagainst MRR.In case of discrepancy the same shall be recorded andimmediately informed to warehouse in charge for rectification.

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Note: For the new vendor first three consignments of starting

raw materials, composite sample shall be prepared from all

the containers (100% sampling), irrespective of the sampling

plan.

Executive-QC shall carry self-sealed polyethylene bags,glass bottles, cleaned sampling devices (such as SS Scoop,thief sampler/glass sampler), prepared labels and samplingrecord to proceed for sampling. Sampling Executive shall verify the physical condition,consignment details and "Under Test" label of the containersagainst MRR.In case of discrepancy the same shall be recorded andimmediately informed to warehouse in charge for rectification.

Executive-QC shall randomly select the containers for

sampling and instruct the warehouse personnel to shift the same

containers to sampling booth.

Executive-QC shall wear the safety devices and

proceeds for sampling of selected containers one by one in

the sampling booth.

Sampling Executive shall check the physical appearance of

the material and mix the contents thoroughly within the container

by sampling devices (SS scoops/Thief sampler for solids or glass

sampler for liquids) and collects the sample in self sealed bags

(for solids) and glass bottles (for liquids). 5

Executive-QC shall randomly select the containers for

sampling and instruct the warehouse personnel to shift the same

containers to sampling booth.

Executive-QC shall wear the safety devices and

proceeds for sampling of selected containers one by one in

the sampling booth.

Sampling Executive shall check the physical appearance of

the material and mix the contents thoroughly within the container

by sampling devices (SS scoops/Thief sampler for solids or glass

sampler for liquids) and collects the sample in self sealed bags

(for solids) and glass bottles (for liquids).

Post sampling, container shall be sealed or closed immediately

and "Sampled" labels shall be affix on the containers adjacent

to under test Labels.

Sampling Executive shall take equal quantity from each

container and collect composite sample .

If the physical appearance of the material is varying from

container to container and specification as well, sampling

activity shall be discontinued and informed to Head-QC.

In such case Head-QC along with QA representative

shall approach ware house and verifies the physical

appearance of the material.

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Post sampling, container shall be sealed or closed immediately

and "Sampled" labels shall be affix on the containers adjacent

to under test Labels.

Sampling Executive shall take equal quantity from each

container and collect composite sample .


container to container and specification as well, sampling

activity shall be discontinued and informed to Head-QC.

In such case Head-QC along with QA representative

shall approach ware house and verifies the physical

appearance of the material.

If the material is confirmed failing in physical appearance,

consignment shall be rejected without OOS investigation.

If the physical appearance of the material in all the containers

is similar and complying, all the samples shall be collected

compositely.

All observations of sampling shall be recorded in "Raw

material sampling record"

Sampled containers shall be shifted to their original place

immediately.

Details of sampling shall be entered into the sampling booth

usage and cleaning record of warehouse. 7

If the material is confirmed failing in physical appearance,

consignment shall be rejected without OOS investigation.

If the physical appearance of the material in all the containers

is similar and complying, all the samples shall be collected

compositely.

All observations of sampling shall be recorded in "Raw

material sampling record"

Sampled containers shall be shifted to their original place

immediately.

Details of sampling shall be entered into the sampling booth

usage and cleaning record of warehouse.

Collected composite sample shall be brought to QC and

divided into 3 parts in sample distribution area.

One part shall be preserved as retention sample (for starting

raw material only) and other two parts shall be used for

complete analysis (at wet and Instrumentation labs)

The QC Analyst shall test the samples as per respective

standard test procedures.

If the sample meets the individual specification, material

shall be approved and retention sample shall be logged.

Incase sample does not meet the specification OOS shall be

raised and investigation shall be carried out.

25.0 Based on the investigation status of the material shall be

decided accordingly.

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Collected composite sample shall be brought to QC and

divided into 3 parts in sample distribution area.

One part shall be preserved as retention sample (for starting

raw material only) and other two parts shall be used for

complete analysis (at wet and Instrumentation labs)

The QC Analyst shall test the samples as per respective

standard test procedures.

If the sample meets the individual specification, material

shall be approved and retention sample shall be logged.



25.0 Based on the investigation status of the material shall be

decided accordingly.

Liquid raw materials (in tankers) sampling sequence:

Sampling Executive shall take prepared sample labels, Glass

bottles, sampling checklist, Glass sampler and proceeds for

sampling.

Sampling Executive shall verify the compartment wise Seal

Naive intact and "Under test labels" before sampling.

Sampling Executive shall break the compartment seals and

open the lids one by one.

Sampling Executive shall rinse the sampler thrice with thematerial and collect the samples from the top of each compartmentcompositely into a glass bottle, if the physical appearance issimilar in all compartments.

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Liquid raw materials (in tankers) sampling sequence:

Sampling Executive shall take prepared sample labels, Glass

bottles, sampling checklist, Glass sampler and proceeds for

sampling.

Sampling Executive shall verify the compartment wise Seal

Naive intact and "Under test labels" before sampling.

Sampling Executive shall break the compartment seals and

open the lids one by one.

Sampling Executive shall rinse the sampler thrice with thematerial and collect the samples from the top of each compartmentcompositely into a glass bottle, if the physical appearance issimilar in all compartments.

Sampling Executive shall open the bottom valves and drain

about 5 to 10 liters of the liquid into buckets. Then samples shall

be collected from bottom of each compartment compositely into a

glass bottle, if the physical appearance is similar in all

compartments.

Post sampling, compartments shall be sealed or closed

immediately and "Sampled" labels shall be affix on the tanker

adjacent to under test Label.


container to container and specification as well, sampling activity

shall be discontinued and informed to Head-QC.10

Sampling Executive shall open the bottom valves and drain

about 5 to 10 liters of the liquid into buckets. Then samples shall

be collected from bottom of each compartment compositely into a

glass bottle, if the physical appearance is similar in all

compartments.

Post sampling, compartments shall be sealed or closed

immediately and "Sampled" labels shall be affix on the tanker

adjacent to under test Label.


container to container and specification as well, sampling activity

shall be discontinued and informed to Head-QC.

ln such case Head-QC along with QA representative shall

personally verify the physical appearance of the material. If the

material is confirmed failing in physical appearance, consignment

shall be rejected without OOS investigation.

If the physical appearance of the material in top / bottom portion

is similar and complying, a composite sample shall be prepared and

brought to QC for analysis.

The QC Analyst shall test the samples as per respective standard

test procedures.

If the sample meets the individual specification, material shall be

approved and tanker material shall be unloaded into bulk storage

tank.11

ln such case Head-QC along with QA representative shall

personally verify the physical appearance of the material. If the

material is confirmed failing in physical appearance, consignment

shall be rejected without OOS investigation.

If the physical appearance of the material in top / bottom portion

is similar and complying, a composite sample shall be prepared and

brought to QC for analysis.

The QC Analyst shall test the samples as per respective standard

test procedures.

If the sample meets the individual specification, material shall be

approved and tanker material shall be unloaded into bulk storage

tank.

Quantity unloaded shall be intimated by warehouse and the

same shall be recorded in the raw material inward! sampling check

list and protocol.

Warehouse shall request a fresh A.R.No. for the composite material

of storage tank once unloading is completed.



Based on the investigation, status of the material shall be decided

accordingly.

Analyst shall perform the analysis as per the product STP and

records the raw data in the. "Raw material test protocol". 12

Quantity unloaded shall be intimated by warehouse and the

same shall be recorded in the raw material inward! sampling check

list and protocol.

Warehouse shall request a fresh A.R.No. for the composite material

of storage tank once unloading is completed.



Based on the investigation, status of the material shall be decided

accordingly.

Analyst shall perform the analysis as per the product STP and

records the raw data in the. "Raw material test protocol".

Analyst shall record instrument usage details in respective

equipment logbooks.

Analyst shall attach the calculations / observations /

chromatograms with the test protocols.

Test wise results shall be compiled in the certificate of analysis

and forwarded to reviewer (section head) for cross verification.

Section head shall review the raw data thoroughly and upon

execution further forwards the report to Head-QC/Deputy for

approval.

In-charge - QC I deputy shall verify the data randomly and

approves the document for release. 13

Analyst shall record instrument usage details in respective

equipment logbooks.

Analyst shall attach the calculations / observations /

chromatograms with the test protocols.

Test wise results shall be compiled in the certificate of analysis

and forwarded to reviewer (section head) for cross verification.

Section head shall review the raw data thoroughly and upon

execution further forwards the report to Head-QC/Deputy for

approval.

In-charge - QC I deputy shall verify the data randomly and

approves the document for release.

Status label (Approved/Rejected labels) labels shall be prepared

and pasted on the under test labels of the containers.

MRR shall be sent to warehouse with status details along with

certificate of analysis.

In the case of failure in quality parameters, OOS (Out of

specification) shall be initiated for raw materials.

Further thorough investigation shall be carried out with document

evidence for OOS materials.

Based on the investigation recommendation, status of the material

shall be concluded.

The final status of the material shall be recorded in the raw

material inward registers along with date of release.14

Status label (Approved/Rejected labels) labels shall be prepared

and pasted on the under test labels of the containers.

MRR shall be sent to warehouse with status details along with

certificate of analysis.

In the case of failure in quality parameters, OOS (Out of

specification) shall be initiated for raw materials.

Further thorough investigation shall be carried out with document

evidence for OOS materials.

Based on the investigation recommendation, status of the material

shall be concluded.

The final status of the material shall be recorded in the raw

material inward registers along with date of release.

Gases, Hazardous and Toxic raw materials:

Upon receipt of Gas cylinders/Tankers, Hazardous, Toxic raw

materials sampling Executive shall verify the details on the MRR

and supplier/manufacturer COA.


Inward register as per the MRR and assigns an Analytical Reference

Number.

Sampling Executive shall approach the consignments and visual

verification shall be done.

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Gases, Hazardous and Toxic raw materials:

Upon receipt of Gas cylinders/Tankers, Hazardous, Toxic raw

materials sampling Executive shall verify the details on the MRR

and supplier/manufacturer COA.


Inward register as per the MRR and assigns an Analytical Reference

Number.

Sampling Executive shall approach the consignments and visual

verification shall be done.

Sampling shall not be performed for such raw materials and

released as per the vendor certificate of analysis.

In the case of captive consumption material transfers, earlier

tested certificate of analysis shall be considered for release.

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presentation of sampling , testing ,release and rejection of Raw materials

Health & Medicine

Transcript of presentation of sampling , testing ,release and rejection of Raw materials