Sr. No.

Risk identification

Probability of Occurrence

Severity

Detection

Risk

Probability Number (RPN)

Current control / Mitigation Measure /Recommended action

I. Dispensing

1

During dispensing of Material wrong materials label may be affixed.

3

92

54

Material comes one by one into the dispensing cubicle during dispensing and verifies by both production and IPQA personnel.

2

Contamination can occur during dispensing because of handling of  wrong material, improper environmental  controls, improper cleaning etc.

7

22

28

Separate area is available for dispensing                                                                        Line clearance is taken prior to dispensing.

3

Wrong quantity of material can be dispensed due to weighing balance and / calculation error.

2

92

36

The materials are weighed in respective balances which are calibrated as per the frequency specified in the SOP .And the materials are verified by 2 personnel’s in order to eliminate manual errors also calculation is verified by the QA.

4

Dispensing of moisture sensitive material

2

92

36

Dispensing is done under controlled condition as specified in the BPRR.

5

Temp., Relative humidity and differential pressure may go out of limit.

5

43

60

All the conditions are verified from the BPRR and SOP before starting the process.
II. Sifting

1

Sifting may be done through wrong sieves.

2

82

32

Sieve no is verified from the BPRR before commencing the operation.

2

Sifting may be done through damaged sieves.

2

82

32

Sieve integrity is checked before and after sifting process.

3

Contamination may be occurred from the left over residue of the previous product.

2

83

48

Cleanliness of the area and equipment is verified by both production and IPQA personnel before the sifting process.

4

Temp., Relative humidity and differential pressure may go out of limit.

5

43

60

All the conditions are verified from the BPRR and SOP before starting the process.
III. Milling

1

Milling may be done through wrong mill screen.

2

82

32

Mill screen no is verified from the BPRR before commencing the operation.

2

Milling may be done through wrong speed or direction of knives.

2

82

32

Milling speed and knives direction is verified from the BPRR before the milling process.

3

Contamination may be occurred from the left over residue of the previous product.

2

83

48

Cleanliness of the area and equipment is verified by both production and IPQA personnel before the milling process.

4

Temp., Relative humidity and differential pressure may go out of limit.

5

43

60

All the condition is verified from the BPRR and SOP before starting the process.
IV. Dry Mixing

1

Improper mixing or de mixing may be occurred during dry mixing stage.

2

82

32

Impeller and chopper speed, dry mixing time is ensured from the BPRR before starting the operation.

2

 Spillage of material through the discharge port may occur during dry mixing.

1

104

40

Inter locking facility is there in the RMG.

3

Contamination arises from the left over residue of the previous product.

1

104

40

Cleanliness of the area and equipment is verified by both production and IPQA personnel before the dry mixing process.

4

Temp., Relative humidity and differential pressure may go out of limit.

5

43

60

All the condition to be verified from the BPRR and SOP before starting the process.
V. Wet Granulation

1

Contamination arises from the left over residue of the previous product.

1

104

40

Cleanliness of the area and equipment is verified by both production and IPQA personnel before the wet granulation process.

2

Over or under granulation may be occurred.

3

92

54

Granulating fluid addition rate and impeller and chopper speed is verified from the BPRR.
 

VI. Drying

1

Contamination arises from the left over residue of the previous product.

1

104

40

Cleanliness of the area and equipment is verified by both production and IPQA personnel before the dry mixing process.

2

Material loss may occur.

3

34

36

Sensor performance check is carried out.

3

Over or under drying granules may be obtained.

2

53

30

Inlet, outlet temp. and drying time is ensured from the BPRR.

4

Contamination may be occurred from the FBD bag.

2

52

20

Product dedicated FBD bags are used

5

Production of static charge may be occurred.

3

52

30

Earthing stud is provided.
VIII. Blending

1

Over and under blending may occurs.

1

104

40

Blending time is verified from the BPRR.

2

Contamination arises from the left over residue of the previous product.

1104

40

Cleanliness of the area and equipment is verified by both production and IPQA personnel before the blending process.

3

Contamination arises from the addition of wrong material.

1104

40

Production personnel check the material before transferring the material to the blender as per specified in the BPRR.
IX. Compression

1

Temp., Relative humidity and differential pressure may go out of limit.54360All the conditions are verified from the BPRR and SOP before starting the process.

2

Wrong material may be taken for compression. 210360Production personnel verify the material before compression operation as per specified in the BPRR.

3

Contamination can occur from the left over residue of the previous product.

3

92

54

Cleanliness of the area and equipment is verified by both production and IPQA personnel before compression process.

4

Improper die filling may occur which results in wt. variation of the tablet.

4

82

40

Hopper level sensor with interlocking facility is there also speed of turret is verified against the BPRR.

5

Any breakages during running of the compression M/C may cause injury to the persons working there.19218

Side door guard with interlocking facility is there.

6Compression parameters may vary from the set value.38248

Provision for checking the compression parameters at specified interval mentioned in the BPRR for both production and IPQA personnel.

7

Wrong punches may be used for compression.

2

82

32

Provision given in the BPRR for using the correct punches.

8

Wrong labeling of compresses tablets may occur.

2

82

32

Before labeling all the data should be verified from the BPRR.

9

Improper storage condition of the compressed tablets may have impact on the product quality.

2

62

24

Storage condition mentioned in both SOP and BPRR.

10

Black particles may appear in the compressed tablets.

7

32

42

Excess lubrication may causes black spot. To avoid this dust caps are provided.

11

Contamination may arise from any traces of metal.

148

32

Metal detection is performed at compression stage also challenge of metal detector is performed at specified interval of time mentioned in the BPRR.
 

X. Coating

1

Contamination can occur from the left over residue of the previous product.

2

83

48

Cleanliness of the area and equipment is verified by both production and IPQA personnel before coating process.

2

Inlet or outlet temp. may be outside from the set value.

3

82

48

Coating process stops along with the spray rate.

3

Compressed tablet of other batch/Products can be taken for coating.

3

91

60

Each and every container is verified with the label and with the BPRR before taking into coating process.

4

Coating parameters may vary from the set value.

1

64

24

Provision for checking the coating parameters at specified interval mentioned in the BPRR.

5

Improper storage condition of the coated tablets may have impact on the product quality.

2

62

24

Storage condition mentioned in both SOP and BPRR.
6Temp., Relative humidity and differential pressure may go out of limit.54360

All the condition to be verified from the BPRR and SOP before starting the process.