Month: August 2021
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)
|1||DESCRIPTION OF PROCESS|
|2||CHANGE CONTROL INITIATED AND APPROVED|
|3||CHANGE CONTROL DEPARTMENT WISE|
|4||CHANGE CONTROL INITIATED TYPE WISE|
|5||CHANGE CONTROL INITIATED CATEGORY WISE|
|6||STATUS OF PERMANENT CHANGE CONTROL|
|7||STATUS OF temporary CHANGE CONTROL|
- 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 Control||Total No. of Change Control Raised|
|01||Permanent Change Control||25|
|02||Temporary Change Control||01|
- 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.||Department||Permanent Change Control|
|08||FRD and Artwork||00|
|10||Human Resource and Administration||01|
01 Temporary change controls were raised from the Review period between Jan to Mar.2021.
|Sr. No.||Department||Temporary Change Control|
- 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 Wise||Permanent Change Control|
|06||Other (if any)||00|
01 Temporary change controls were raised from the Review period between Jan to Mar.2021.
|Sr. No.||Type Wise||Temporary Change Control|
- 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 Category||Permanent Change Control|
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 Category||Temporary Change Control|
- 5.0 Status of Permanent change control for Jan – Mar 2021:
|Sr. No.||Year||Total CC Raised||Open||Closed|
- 6.0 Status of Temporary change control for Jan – Mar 2021:
|Sr. No.||Year||Total CC Raised||Open||Closed|
- 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 By||Reviewed By||Approved By|
|Name & Designation|
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.
In this Topic I have identified some ways by which we can reduce Human Errors (but not limited to)
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.
In the below table i have mentioned some data integrity Risk Assessment Template for your reference and we can make such type of Assessment in other areas or systems or procedure also do pl go through this.
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:
- Learn from it. Don’t get defensive. Be willing to look at it objectively.
- Own it. Readily admit to the error. Don’t make up excuses. Figure out and share openly what they can learn from it.
- 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.
- 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.
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