With the implementation of management systems or models (quality, environmental or otherwise), have a documentation system (SD) efficiently has become a fundamental need for the proper management and control thereof. In this context the implementation of the Good Practice Documentation (BPD), and a tool can become efficient and helpful.
What is the purpose of BPD ? Basically set controls to the prevention of communication errors, ensuring that staff follow appropriate procedures, in parallel with the implementation of the BPD facilitates the traceability of products, SD effect proper allows us to reconstruct the history of a product, including the use and disposal of raw materials, inputs and intermediate products, bulk products and finished products.
documentation of our system must be able to demonstrate that products and raw materials associated with their manufacture, were monitored throughout the process. To achieve this requires that all specifications, formulations and manufacturing instructions and procedures and records, are formalized, that is, well written and contain no errors, it is essential therefore to ensure the integrity and readability documents.
In conclusion to implement BPD is achieved:
1) Increase efficiency in the organization of documents.
2) Reduce the effort associated the compliance of various regulatory frameworks.
3) Possible removal of some audits.
4) Improve the effectiveness and scope of training.
5) Increasing efficiency and productivity.
6) Facilitating communication.
2. DOCUMENTS AND THEIR USE
Daily and in almost any context (work, student, etc.). We have contact with a wide range and quantity of documentation. Certainly the management of documents, require no less time for both individuals and businesses, therefore the implementation of the BPD involves optimizing the use of that time.
Concact lies the importance of the documents?, there requirimientos regulatory, legal and / or policy that requires the existence of an SD , consisting of certain documents.
For example, the BPE the WHO Pharmaceutical down that good documentation is an integral and essential part of what is called " system quality assurance, therefore, must be related to all aspects of Practice . ISO standards (9001 and 14001 to name just two) require a manual, policies, objectives and minimum
documented procedures and assuming however possible requsite absence of any kind documetnos demand the use of common sense we can see obvious advantages in applying the BPD :
* Standardize and regulates certain activities
* Minimize the risk of error.
* Increases or strengthens the skills of staff
* Optimize the use of productive time and the training
From the analysis of the benefits we can infer the most common uses for documents, highlighting among others:
* Definition of specifications for materials (reagents, consumables, raw materials, packaging, etc) * Define specifications
tools and methodologies production and inspection / test
* Ensuring the internalizing and handling of the various procedures of the organization.
* Delivery of data used in decision making * Registration information
3. DOCUMENTS (Definition)
1. Organized form of information that can serve as evidence. This information can be in many kinds of format. James Vesper
2. Information and its supporting medium. ISO 9000:2005
3. * Diploma, letter or other writing concerning about a fact illustrated, mainly from historical data. * Written in reliable data contained or capable of being used as such to prove anything. RAE
4. Information or similar relationship, contained in a medium that allows the duration and use. Author's blog
Therefore a document can be in any medium:
* Paper
* * Computer Audio (electronic - digital) * Visual
result can be considered as documents the following examples:
* Signs, banners, and posters, etc
* Plans, sketches, diagrams, etc.
* computer records, databases, spreadsheets, etc.
* Video security, corporate, advertising, etc. * Memoranda
, fax, email, supplied text messages, conversations via messenger, skype, etc
* Prescriptions, chemical formulas, etc. *
standard operating procedures.
* Log of a team, work books, books by
* decrees, laws, regulations, etc. ------------------------
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