Hi! I need to improve the quality systems and documentation in a unit of pharmaceutical company where I’m working. Pls suggest hw to start and go about it. Thanks & regards Indira.S
From India , Bangalore
Hi Indira, the ISO 9001:2000 quality management system is a comprehensive tool to control quality of both inouts and outputs. It can also be applied to most industry operations. The key here is also not to make these procedures too complex, and that staff be part of the process in developing suitable procedures.

From Australia ,
Hello Sir! I think both go hand in hand ,Process and documentation. We should document what we do, and do what we document. Indira.S:-)
From India , Bangalore
Hi Indira, the process and documentation go hand in hand. It is essential that the process be mapped out or flow-charted into steps and resources allocated. The flow chart can then be writtent into easily read procedures.
The advanced procedure development take into account Safety, Health, Environment issues. This woudl transformt eh ISO9001 std. to ISO 18000. However, seeing that it sound that you are starting this for the first time, it is recommended that you start with ISO9001:2000.
Hope this helps.

From Australia ,
dear indira,

its not the same. if you are only a document controller then your work is only to keep documents in proper accessible method. you have nothing to do with process/ production.

on the other hand if you are QA/QC or Production/execution engineer then yo hav to refer document to execute the work.

so according to your job responsibility you have to continue with document.

if you are document controller then you have to handle all departments document in proper file but if you are only production people then only you have to keep you process related document to follow the path.

on the other hand if you are related to legal/commercial section then all documents are important for you to fight against any dispute.

if you have ERP system for that then ou have to fllow your companies system. but to put in excel just scan all documents in PC. then enter in excel, the required documents serial wise which is for your department. and write down in the subject so that you can know which data you want and then link it to the scanned related document. thsi process will allw you to access any paper or method you want in respective time.

even you have to enter during the process, the reference number of method you followed. so any correction, you can rectify in that method.


From United Arab Emirates , Dubai
Dear Indira,The ISO standard has been revised and all new aspiring companies should do documentation as per ISO:9001-2008.Even the existing certified companies shall have to get recertification within 1 1/2 years.The manual will contain management and the team's committment to follow ISO:9001-2008. The set of procedures followed have to be documented in a separate documentation.Formats have to be designed to meet the ISO:9001-2008 requirements.For any further clarification pl use my e-mail ID:[email protected] PRUTHEE
From India , Delhi
Hello Indira,
I f you are looking for only one unit of the pharma company then you should :
a)identify all the processess in that unit.
b)map the processess as flow charts
c) identify people responsible for each operations.
d)identify the resources required for each operation.
e)write a brief and effective procedure to be followed including the formats and records to be used.
I f your company is planning for GMP certification then almost 90% of the documentation and procedures will be in place.
I f you have any queries write to me .
Thanks & Regards
sudhir varma

From India , Bangalore
Hello Partners in learning I also need to document and write the process for a chain of coffee shops. Would be very helpful if there can be any help or examples attached Thanks Abbas
From Indonesia , Jakarta
Im in Quality dept in a call centre, the avenues seems to be less and consideration for quality to ops as team leader is very less why is that? Any particular avenue that needs to be improved in general?
From India , Madras
.....anyone who requires any sorta material on Quality Management may please email me the requirement, and i’d send you that....
From Pakistan , Karachi

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