Author: chandrasekhar Panda

Procedure for Dispensing of solvent and liquid


1. Purpose

To provide a standard operating procedure for dispensing of solvent and liquid material in the warehouse.

2. Scope

The scope of this SOP is applicable for dispensing of solvent and liquid material in the warehouse at [company name].

3. Responsibility

Warehouse person: Dispensing of solvent and liquid materials

Warehouse supervisor: To verify dispensed material details, to record the activities in the batch manufacturing record

Manufacturing supervisor: To verify dispensed material details against the standard quantity mentioned in batch manufacturing record, to ensure calculation correctness

QA Person: To accord line clearance

Warehouse Head: To monitor the procedure compliance

4. Definitions

Not applicable

5. Procedure

5.1. Manufacturing person shall initiate a material requisition note for the required product. The requisition will contain details of material name, material code, batch number, and required date.

5.2 Warehouse person shall receive the material requisition note and plan for the material dispensing activity as per material requisition.

5.3 Bill Of Material (BOM) with Raw Material details (A.R. Number) for the batch to be dispensed shall be provided to the warehouse by the manufacturing department.

5.4 Material management software shall generate the formulation order where material details shall get arranged automatically based on FEFO (First Expiry First Out) followed by FIFO (First In First Out).

5.5 Only approved material will get populated in the list.

5.6 At a time, single batch material shall be dispensed. An open container of the materials shall be used first for dispensing.

5.7 Ensure that all required solvents or liquid materials are in the approved state before dispensing and no material is due for a retest.

5.8 Approved solvents or liquid containers shall be kept ready (through material movement route) after wiping the containers with a lint-free duster. Ensure that no leakage of solvent in solvent storage area at the time of entering into the room. Material shall be kept on the spill control pallet with adequate segregation.

5.9 Warehouse and Manufacturing personnel shall enter into the solvent dispensing area from the man movement change room.

5.10 Warehouse person shall ensure that area is cleaned for dispensing activity before the start of the activity. Accessories used for the dispensing is available with clean status label and instruments such as weighing balance are calibrated.

5.11 Use required Personal protective equipment (PPE) such as hand gloves, nose mask, Earmuff, Earplug, Goggle while working in dispensing area.

5.12 Switched “ON” the Fuming Hood and allow the area to stabilize for 5 minutes.

5.13 Ensure that Fuming Hood is working as intended.

5.14 Ensure that the temperature, relative humidity, and differential pressure are within the acceptable range.

5.15 Before starting the dispensing activity, line clearance should be done to ensure that area is cleaned, no previous product documents, and the residue is available in the area.  Line clearance checks for dispensing shall be done by the user department, followed by the QA department. Line clearance shall be recorded in the batch manufacturing record.

5.16 The dispensing activity shall be carried out under the supervision of personnel from the warehouse and manufacturing department.

5.17 Clean container shall be brought into Solvent dispensing booth / fuming hood and place it on the balance to record the tare weight.

5.18 Adequate earthing to be provided by using crocodile clip during dispensing to the solvent container, weighing balance and container in which the dispensed solvent to be stored.

5.19 During dispensing, details to be verified on the material label, such as Description of the material, Item code number, A.R. Number, Retest date, and expiry date.

5.20 Material shall be weighed as per the quantities defined in BOM using the weighing balance. Ensure that the correct capacity of the weighing balance is used.

5.21 Material shall be dispensed in the pressure vessel designed to store solvents. Solvent dedicated pump shall be used for solvent transfer. Attach the crocodile clip to solvent drum. The lid of solvent drum shall be open slowly to avoid the suddenly flow of fumes.

5.22 The solvent transfer pump shall be placed into solvent container. Compressed air operated pump shall be used to transfer the solvent from main container to the container in which the material is to be dispensed. Adjust the flow of compressed air to transfer the solvent as per requirement.

5.23 Warehouse supervisor shall verify the standard quantity mentioned in the batch manufacturing record to ensure that the correct amount of material is dispensed. Adjust the quantity of solvent as needed as per the BOM.

5.24 The dispensed material shall be labeled with details such as product name, batch number, material name, item code, A.R. Number, Lot No., and container No.

5.25 Manufacturing supervisor shall verify the quantity dispensed against the standard amount, material code, A.R. number, gross weight, tare weight, net weight, and other details on the dispensed material label and verify the correctness concerning the batch manufacturing record.

5.26 Close the lid of solvent drum and the SS container in which material is dispensed

5.27 “Cleaned” status labels of containers shall be retained at the time of dispensing of raw material and attached with the batch manufacturing record.

5.28 Ensure that the dispensed container wheels shall be cleaned before transferring from dispensing area to the manufacturing room.

5.29 Different lots’ solvent shall be issued in separate containers.

5.30 After completing dispensing, the remaining material container shall be transferred to the warehouse through the material airlock.

5.31 Used Utensils and accessories shall be labeled with the status label as “Unclean”.

5.32 At the end of dispensing, if any material physical quantity found different from material management software stock, it should be adjusted in the system up to the allowable amount. If the difference is more than the defined acceptable range, it shall be investigated.

5.33. Before starting of next batch, cleaning of area and fuming hood shall be performed.

5.34. Cleaning process shall be documented in the area and equipment logbook.

5.35 After completion of dispensing activity, personnel working in the area shall remove the hand gloves and cut them to prevent re-use of it. Discard the gloves in the waste bin.

5.36 Any spillage of material while handling shall be handled using respective ingredient Material Safety Data Sheet (MSDS).

5.37 Spill control kit with absorbent pad shall be used for any accidental spillage of material.

6. Frequency

Every batch manufacturing where solvent is part of the BOM

7. Formats

Format for Logbook of solvents and liquids dispensing (Following are the content of logbook)

Date

Product Name

Batch No.

Batch Size

Material Code

Dispensing Start time

A.R. No.

Quantity dispensed

Dispensing End time

Dispensed by

Dispensing checked by

Cleaned by Cleaning checked by

Procedure for Storage and Dispatch of Finished Goods


1. Purpose

To provide a standard operating procedure for Storage and Dispatch of Finished Goods from the finished goods store.

2. Scope

The scope of this SOP is applicable for Storage and Dispatch of Finished Goods from the finished goods store at [company name].

3. Responsibility

Finished Goods Store: Storage of finished goods, loading finished goods in the container or transportation vehicle. Placement of data logger with the finished goods to be shipped.

Quality Assurance: To release of finished goods and checking batches to be shipped and container to be used for transportation.

Logistic department: Arrangement of the vehicle from the approved transporter to ship the consignment. Preparation of documentation required for transportation and export of finished goods. To provide details to finished goods store regarding vehicle arrangement.

Approved transporter: Transportation of export consignment to seaport or airline cargo, checking documents’ adequacy for appropriateness.

4. Definitions

Not applicable

5. Procedure

1. Storage of finished goods

  • Finished goods shall be received from the packing department along with the batch details.
  • The document shall contain information about product name, product code, batch number, manufacturing date, expiry date, and packed quantity.
  • Ensure that all the containers shall have labels and quantity details. On receipt of the batch in the finished goods store, batch details shall be verified against the documents received.
  • Entry of material receipt shall be done in respective logs/ software.
  • The goods shall be stored at appropriate storage conditions as per labeled storage conditions. The batch shall be stored in the quarantine area/ under test area.
  • Location details shall be updated in the respective area log/ software.
  • Finished goods shall be arranged in the storage area in such a manner to prevent contamination, cross-contamination, and mix-ups.
  • Once QA releases the batch, it shall be transferred from the quarantine area to the approved area.

2. Dispatch of finished goods:

  • Get the weight chart for the consignment with details of batch number, container number, gross, tare, and net weight and share it with the logistic department.
  • Logistics shall arrange the container for the consignment at the plant.
  • Before consignment, check the mode of transportation. For example, if the mode of transportation is by air, the finished goods store person shall wrap the pallet with a thermal blanket.
  • Before shipment, the finished goods store person shall wrap pallets with stretch film.
  • Finished goods store person shall ensure that the arranged transporter is approved by QA department and agreement with the transporter is valid.
  • Dispatch of finished goods shall be done through only the Approved Transporter.
  • Before transportation of finished goods, the vehicle shall be checked for the vehicle’s condition and cleanliness.
  • In case the customer is arranging their transportation, detailed information regarding the transporter should be ensured. List of such customers shall be maintained by finished goods store. As and when new customers and products are introduced, the list shall be updated.
  • After the vehicle’s arrival, the finished goods store person shall inform to QA department for vehicle inspection and consignment verification.
  • Finished goods store person and QA person shall check the finished product and inspect the vehicle, loading platform, and rainproof status before loading of consignment.
  • Finished goods store person shall load the goods in the container as per the shipping document.
  • Finished goods store person shall do documentation of shipment loading.
  • When shipment needs to send with the controlled condition, finished goods store person shall use calibrated temperature sending device to check the container’s temperature and record it in the logbook.
  • Before starting batch loading activity, ensure that the container’s temperature complies with the required product storage condition mentioned on the shipping mark.
  • Ensure that temperature controlling equipment is in ON condition while loading the finished goods.
  • After completion of loading the finished goods, ensure that vehicle should maintain the required temperature.
  • Finished goods store person shall ensure that material is not damaged during the loading.
  • While loading, if required, use airbag or strapping tools to prevent goods tilting or damage during transportation.
  • It is to be ensured that the protection of finished goods is done in such a way that the vehicle is protected from calamities conditions and rain showers.
  • Before closing the shipment container, photographs shall be taken and attached with the documents for future reference.
  • Once the shipping container is filled, fix the seal and hand over the vehicle to the transporter.
  • Required commercial documents shall be handed over to the transporter.
  • Acknowledgment for shipment handover shall be taken from the driver.
  • Logistics department shall additional documents required to facilitate shipment, such as invoice, Weight Chart, Non-Hazardous declaration.
  • Dispatch documents shall be retained for product expiry +1 year or 5 years, whichever is longer.

3. Precautions during air and sea shipment:

  • Placement of data logger as per shipment validation study.
  • Checking of container cleanliness.
  • Airbag to be used to fill the empty space.
  • Cord strap to ensure pallet will remain at its place and hold the container adequately.
  • Ensure that the doors of the containers are placed adequately.
  • Ensure that thermal blanket is wrapped for an air shipment.
  • In case of shipment, mode changed from sea to air, ensure that thermal blanket is wrapped. If shipment mode is changed from air to sea, remove the thermal blanket.
  • Ensure that data loggers are placed in the shipment as defined for the respective product, customer, and mode of shipment.
  • Ensure that the data logger is ON during shipment.
  • During the rainy season, depending on transportation mode and route, additional layering of the pellet can be done using poly bags to protect the goods.

6. Frequency

Every shipment

7. Formats

  • Format for Checklist for Dispatch of Finished Goods
Product NameRecord the observations
Batch No. 
Date of shipment 
Cleanliness of vehicle 
Vehicle details 
Temperature before loading the goods 
Temperature after loading the goods 
Temperature sensor Id. 
Pallet No. 
Container numbers 
Details entered By 
Details verified by 
  • Format for acknowledgment from vehicle driver (this can be in multiple languages for understanding of driver)
Product Name:
Date of dispatch:
Information for driver to note:
1. In case of any abnormality observed during the transportation, driver needs to immediately inform to company and transporter’s main office.
2. Ensure that cooling of container is maintained as per storage condition.
3. If cooling unit malfunctions, alternate arrangement needs to be done immediately with the help of transporter’s main office.
4. To inform immediately to transport company in case of any event with the vehicle during carrying the goods.
Explained by finished goods store person:   Signature/ Date:
Acknowledged by driver:   Signature/ Date:
  • Format for transportation details:
Sr. No.Product nameCustomerDestinationMode of transportationContainer storage conditionData logger requirement
       
       
  • Format for list of approved transporter
Sr. No.Name of TransporterAddress of TransporterTypes of vehiclesValidity of Transporter agreement
     
     
     

Handling of Retest and Expired Materials


1. Purpose

To provide a standard operating procedure for management of Retest and Expired Materials in warehouse.

2. Scope

The scope of this SOP is applicable for management of Retest and Expired Materials in warehouse at XYZ Company.

3. Responsibility

Warehouse person: Identify and segregate the material which due for retest and expired on daily basis.

Warehouse supervisor: Checking of material which due for retest and expired.

Warehouse head: Overall responsibility to ensure compliance to the procedure

4. Definitions

Not applicable

5. Procedure

5.1 Handling of retest material

5.1.1 Material due for retest required to be transferred to the area designated for quarantine storage.

5.1.2 Warehouse person shall check the material under retest on a daily basis and generate a list of materials due for retest for that particular day using material management software.

5.1.3 Supervisor will verify the list and handover to the warehouse person who is responsible for material transfer.

5.1.4 Warehouse person shall transfer the identified materials, which are due for retest to the quarantine area and store the same at available space.

5.1.5 Material shall be stored in the area at suitable conditions applicable for the material.

5.1.6 Material location chart shall be updated with the new location in the material management software.

5.1.7 Material shall be labeled with Quarantine Label. Previously affixed label with Approval status shall be defaced with the marker.

5.1.8 Quality Control (QC) Laboratory will get the intimation through the material management software regarding material testing. QC will plan for the testing by considering the priority as per the production planning.

5.1.9 Once the material testing is completed, the material status will get automatically updated in the material management system based on the result generated in the laboratory information management system. The material shall be transferred to the approved material area or rejected material area based on the quality.

5.1.10 Rejected material shall be handled as per the procedure for handling of rejected materials.

5.1.11 In case of any material which needs to be used once after opening the container, it shall be tracked separately, and after dispensing, it shall be blocked with the help of QA and shall be destroyed as per the process of material destruction.

5.2 Handling of expired material

5.2.1 Warehouse person shall check the expiry status of material on a Monthly (End of the month for the next month) basis and generate a list of expired materials for that particular day using material management software.

5.2.2 Supervisor will verify the list and handover to the warehouse person who is responsible for material transfer.

5.2.3 Warehouse person shall transfer the identified expired materials and shall move to the rejected area.

5.2.4 List of materials available in the rejection room shall be updated.

5.2.5 Material shall be labeled/ stamped with ‘expired material’.

5.2.6 In case of information received from the material manufacturer for extension of material shelf life, it can be done with adequate evaluation.

5.2.7 In order to extend the shelf life, additional information regarding the stability study of material, the container closure system of material in which stability study performed, updated CoA from the manufacturer shall be acquired.

5.2.8 Once the information is received, it shall be reviewed by warehouse head and further approval from Quality Assurance Head shall be taken. Quality Assurance Head shall evaluate all the supporting data thoroughly for shelf life extension.

5.2.9 If Shelf life extension is not required then Expired materials shall be destroyed as per destruction procedure and same shall be approved by Quality Assurance Head.

Trending of Change Control


Trending of change controls shall be performed on quarterly basis and here i have given one example and Template to explain you about the Trending of change control. In order to prepare chart you have to use Excel sheet and according to your requirement you can use different types of charts. The below mentioned departments and figures are given for reference purpose only and based upon your organizations SOP requirement you can redesign the things. Hope you read it and gain some new knowledge or learn something new

Review of Change Controls (Jan – Mar 2021)

Index

Sr. No.Contents
 1DESCRIPTION OF PROCESS
 2CHANGE CONTROL INITIATED AND  APPROVED
 3CHANGE CONTROL DEPARTMENT WISE
 4CHANGE CONTROL INITIATED TYPE WISE
 5CHANGE CONTROL INITIATED CATEGORY WISE
 6STATUS OF PERMANENT CHANGE CONTROL  
 7STATUS OF temporary CHANGE CONTROL  
 8SUMMARY
 9CONCLUSION
 10APPROVAL
  • 1.0 DESCRIPTION OF PROCESS :
  • Change Control – A planned alteration which is documented and considered before implementation and is either permanent or for a fixed validity period (temporary).
  • All changes shall be handled as per SOP on “Change Control Management”, SOP XYZ.
  • Change control shall be initiated by concerned or initiator department and login shall be done by Quality Assurance.
  • After categorisation and comment from all concern departments, Quality Assurance shall approve or reject the change control.
  • Status of approval / rejection shall be communicated to initiator department and implementation of changes shall be done respectively.
  • Change controls shall be categorised as “Major” and “Minor” as per the impact analysis of changes on Safety, Identity, Strength, Purity and Quality of product / Material / Documents.
  • All major and product related change control shall be approved by CQA.
  • Inclusion of the requirement for the verification of the old document invalidation before issuance of the revised document.
  • This change control review includes,
  • Total no .of change control initiated approved and closed.
  • Total no. of change control raised department wise.
  • Change control initiated type wise (i.e. Permanent, Temporary, Facility, Document, Material, Equipment and Other )
  • Change control initiated category wise (i.e. Major or Minor).
  • Any specific highlight for change control review.
  • 2.0 CHANGE CONTROL INITIATED AND APPROVED (Jan – Mar 2021) :
  • Total  26  change controls were raised for the January – Mar 2021
Sr. No.Type of Change ControlTotal No. of Change Control Raised
01Permanent Change Control25
02Temporary Change Control01
 Total No.26
  • 3.0 CHANGE CONTROL DEPARTMENT WISE (Jan – Mar 2021) :
  • Total 25 permanent change controls were raised, out of them 05 for Packing Department, 03 for Quality Assurance Department, 07 for Quality Control Department, 09 for Manufacturing Department, 01 for Human Resource and Administration Department, Nil for FRD Department, Nil for Technology Transfer/Art work Department, Nil for Engineering Department and Nil for Information Technology Department.
Sr. No.DepartmentPermanent Change Control
01Production14
02Quality Control07
03Quality Assurance03
04Warehouse00
05Engineering00
06Technology Transfer00
07Information Technology00
08FRD and Artwork00
09Packaging Development00
10Human Resource and Administration01
 Total No.25

01 Temporary change controls were raised from the Review period between Jan to Mar.2021.

Sr. No.DepartmentTemporary Change Control
01Production0
02Quality Control01
03Quality Assurance0
04Engineering0
05Technology Transfer0
 Total No.01
  • 4.0 CHANGE CONTROL INITIATED TYPE WISE (JANUARY – MARCH 2021) :
  • Total 25 Permanent change controls were raised, out of them 25 for Document Type, Nil for Facility Type, Nil for Material Type, none for Formulation Type, none for Instrument Type and none for Other Type.
Sr. No.Type WisePermanent Change Control
01Document25
02Facility00
03Material00
04Formulation00
05Instrument00
06Other (if any)00
 Total No.25

01 Temporary change controls were raised from the Review period between Jan to Mar.2021.

Sr. No.Type WiseTemporary Change Control
01Material01
02Document00
03Facility00
04Formulation00
05Equipment00
06Other00
 Total No.01
  • 5.0 CHANGE CONTROL INITIATED CATEGORY WISE (JANUARY – MARCH 2021) :

Total 25 Permanent change controls were raised, out of them 25 for Minor category and none for Major category for review period of Jan-Mar 2021.

Sr. No.Type of CategoryPermanent Change Control
01Minor25
02Major00
 Total No.25

Total 01 Temporary change controls were raised, out of them 01 for Major category and none for Minor category for review period of Jan-Mar 2021.

Sr. No.Type of CategoryTemporary Change Control
01Minor01
02Major00
 Total No.01
  • 5.0 Status of Permanent change control for Jan – Mar 2021:
Sr. No.YearTotal CC RaisedOpenClosed
012021250025
  • 6.0 Status of Temporary change control for Jan – Mar 2021:
Sr. No.YearTotal CC RaisedOpenClosed
012021010100
  • 8.0 SUMMARY
  • All change controls were login, reviewed and approved as per SOP.
  • Total cumulatively 06 change controls were raised in period of Jan – Mar 2021.
  • Out of 26, 25 are Permanent change controls and 01 is temporary change controls.
  • Out of 26 change controls, All 25 Permanent change controls are closed and 01 Temporary change controls is in open stage.
  • For Permanent change controls, There are 14 change control raised by Production Department which are related to Document
  • There are 07 Change Controls raised by Quality control  Department which are related to Document
  • There are 03 change controls raised by Quality Assurance which  are related to Document.
  • There are 01 change controls raised by Human Resource and Administration Department
  • Which is related to Document
  • There are none change controls raised by Engineering Department.
  • There are none change controls raised by FRD Department.
  • There are none change controls raised by Warehouse Department.
  • 9.0 CONCLUSION
  • All Change Controls are handled as per procedure described in SOP “Change Control Management”.
  • 10.0 APPROVAL
 Prepared ByReviewed ByApproved By
Signature   
Date   
Name & Designation   

9 ways to Reduce Human Errors in Pharmaceuticals and other industries


Human errors plays a major role in the violation of GMP and can lead to the deviation in different stages of manufacturing. Human errors have major or critical impact on products and may lead to the Data Integrity however due to various reasons human errors can occur which we have discussed in the earlier Topic.

Refer https://pharmaceuticalupdates.com/2021/08/13/contributing-factors-that-can-lead-to-human-errors-in-pharmaceutical-and-other-industries/

In this Topic I have identified some ways by which we can reduce Human Errors (but not limited to)

1.Training :

Training plays a major role to reduce human error so when a person is joined in any organization it is the responsibility of his/her department Head and Quality assurance to provide him or her required training based on Experience and Qualification before assign him/her any work. The department head or Quality assurance should evaluate him/her by asking various questions related to Standard SOP procedure and job related things to get confident that the person can do the work and don’t leave the person along i.e assign any experienced or responsible person to keep watch on his/her and to guide him/her. Irrespective of designation and nature of work on job Training, cGMP, HR related training, Safety and Personal Hygienic & basic QA SOP training is required to everybody those who are working in pharmaceutical i.e Contract work men, freshers, Experienced and Senior persons. Organization to Organization systems are different so Training is required for Experience persons also. In case of any incidents or deviation or event or Compliant the root cause and the related Corrective and Preventive action (CAPA) shall be informed to all the the persons those who are involved in the operation or activities.

2. Improve Communication :

Communication plays an important role in the reduction of human errors. Communication among all the departments is very necessary for smooth functioning of any organization hence good communication ( mail, oral and written) is required between Quality Assurance to other departments (Production, Quality Control, warehouse and Engineering) at every stage. As you know that organization is running in different shifts (First, Second and Third shift) so during shift handover communication is very important and before leaving the organization charge handover is must required. we can improve by introducing Daily report for each Shift persons and they have to clearly mention the status of their respective areas so that it will become useful to next shift persons to know the status and to plan their next activities. Good communication is also required between Quality Assurance and Corporate Quality assurance.

3. Workload :

Workload can play an important role in the reduction of human errors. If a person is involve in multiple activities or work continuously without rest due to some reason then he/she might can do the mistake and in order to avoid such we have to take some precautions. If required tasks or the work can be redistributed between team members or shifts or Head of Department can Assess the balance of workload across a shift and Experienced operators may be able to utilize for handling high task demands whereas inexperienced staff may be less able to handle the situation or work. Task analysis should consider both physical and mental workload. Ensure that workload assessment considers visual inputs (eg scanning display screens, looking out of windscreens, CCTV) and Set clear roles and responsibilities by ensuing that staff are clear on their priorities which will help to ensure that even when workload is high, staff are able to focus on key activities.

4. Job Assignment :

Performance of the individual personnel should be monitored by his/her Department head or supervisors and job should be assigned to their Education Qualification and work Experience or based on capabilities which can give better results in reducing human errors at workplace. Every time you assign a job and find out the person who is best to perform the particular task or work and if required we can change the job assignment of the persons based on performance to reduce the human errors.

5. Redesign Procedures :

The main way to reduce accidents caused by human errors is to redesign the job task or the Procedures. A simply designed job will reduce confusion, stress and mistakes are less likely to occur. Procedures are very important and should be well trained to the workers which should be clear, precise, and easy to read. They should be in easily understandable manner by the workers. For Example we can simplify the our Standard Operating Procedure (SOP) which are difficult to understand or can change in formats those are lengthy or difficult to follow by the users. We should try to made our Instruction (SOP, Batch records, Standard test procedures, General test procedure) very clear and short and precise for better understanding for the users. we can modify the complex or confusing instructions or if required you can display the confusing or complex things by using flowchart at the workplace or make a list of such things and inform to all the users in order to reduce errors.

6. Organization working culture and Environment :

As we know that organization working culture and Environment plays an important role in the mind of the employee working in the particular organization. So in order to reduce human errors positive work culture is required at work place which includes Providing support for one another, including offering kindness and compassion when others are struggling, Avoiding blame and forgive mistakes, Inspiring one another at work and Treating one another with respect, gratitude, trust, and integrity.

7. Equipment Design :

Equipment design plays an important role in reducing human errors and due to the manual system person can make mistake in Manufacturing, Quality Control and packing area so in order to overcome from this problem. we should adopt the automated system and should not bypass the system and if required we can fix camera in some areas where critical activities are going on to monitor the entire system and thus can reduce the human errors.

8. Senior Management or organizational factors :

Senior managements or organizational factors plays an important role in reducing the human errors and management should involve in the problem which are facing by the employee i.e in some organization management is forcing to the employee to do some works which is not as per the procedure and in latter stage it can create a violation to the system or procedure and can be considered as human error so such types of things are thoroughly investigated and alternate solution to be adopted in order to reduce the human errors.

9. Cross Verification of the Activity :

Cross Verification of the activity plays an important role is reducing the human errors i.e doers can make mistake so his/her works shall be checked by his senior and same shall be cross verified by Quality Assurance to reducing the errors. If required some critical activities shall be crossed verified by senior persons to reduce the human errors.

Contributing factors that can lead to Human Errors in Pharmaceutical and other Industries


Hi dear Friends welcome to everyone to my blog including my daily readers and i have prepared one page which contains some factors which can lead to Human Errors ( but not limited to)

How Mistakes Can Actually Make Employees Better

When employees make a mistake at work (as we all do), they need to:

  1. Learn from it. Don’t get defensive. Be willing to look at it objectively. 
  2. Own it. Readily admit to the error. Don’t make up excuses. Figure out and share openly what they can learn from it. 
  3. Fix it. Good employees will do their best to rectify their wrongs. Granted, there may be times when the damage cannot be completely fixed. Nevertheless, they can establish a timeline for fixing the mistake and communicating their entire process to leadership.  
  4. Make sure the same mistake will not be repeated. This step is the most important in the learning process. The whole point of learning from your mistakes is to recognize them, document them and establish safeguards that ensure the same errors won’t happen again. This goes for not just the individual but the company as a whole. 

Donation


Hi to all my readers and followers. This website i have created to post the topics which will be useful for the pharmaceutical professionals to gain knowledge and if you think that this website is useful to you then you can donate what ever you want in my below mentioned account

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