Other links
QMS
-Quality policy statment
-General requirments
-Documentation requirments
-Control of documents
-Control of records
..dashen Lehulachen!!!
Yehulachen Mircha Dashen Bera
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Welcome
to the Documentation requirments
General
Our quality management system documentation includes:
- Documented statements of the quality policy and quality objectives.
- Quality manual
- Documented procedures (established, documented, implemented and maintained) required by ISO 9001, 2000,
- develop employee's competence, team work, motivation, participation and also creat conducive work environment.
- Documents needed to ensure the effective planning, operation and control of processes.
- Records required by ISO 9001, 2000 and by Dashen Brewery share company.
Quality system Documentation structure
- Quality manual
The quality manual (designed by QM) is the first-level company document.It contains company Quality policy and establishes responsibilities.
It also provides organizational structure and details how each company department or function is to meets its quality objectives.
- Quality system procedures
The Quality system procedures is the second-level company document.It contains detailed information on specific quality system procedures including the purpose
and scope of the procedure; individual responsibilities; method and resources to be deployed; and instructions on required documentation.
- Quality plans and other level 3 documentation
The company's third level of quality management system includes,but is not limited to, any and all work documentation
including quality plans, work orders, work instructions, records, and inspection reports.Such routine documentation
is used to analyse results and performanceof the processes and production for the purpose of meeting or exceeding predetermined
quality objectives.Generally,any documented policy or procedure not contained in the quality manual or the quality system procedures
is classified as a third-level document.
- Manual use and cross referencing
Where a specific task or situation arises that is not covered by the quality systems procedure
manual,a controlled draft shall be prepared to control the activities affecting quality.The draft shall be reviewed and approved with an expiration or time limit.
If necessary,a new procedure can be developed.If no procedure is necessary, termination of the procedure with an explanation shall be required.
Quality manual
Dashen Brewery share company has established and maintained a quality manual that includes:
- the scope of the quality management system , including details and justification for any exclusions
- the documented procedures established for the quality management system ,or reference to them, and
- a description of the interaction between the processes of the quality management system.
Control of documents:
- Dashen Brewery share company has established and maintained documented procedures to control all documents of internal
and external origin that are pertinent to the quality system.
- The management representatives is responsible for the issue ,control and recall of all documents.
- Documents are periodically checked for adequacy.
- Document change and modification are made only after formal review by the departement responsible
for preparing approving the original document.Quality departement manager(MR) is always informed
immediately about the change or modification to reflect the amendment on the master list.
- Company wide documents are reviewed and approved by management and departement specific by department managers.
- All absolute documents are promptly removed from the point of issue and use.And are identified if they are retained for other purposes.
- It is ensured that all documents pertaining to work instructions ,drawings,technical requirements,specifications,
procedures etc.are available at all points of use.Departement Managers are required to ensure that employees are aware of current
procedure status at all times.
- A master document and list of current documents are maintained.
- A copy of each superseded documents is maintained for the purpose of treaciability unless otherwise
decided by the management representative.
- Any proposed changes to any controlled document is reviewed and approved prior to issuance.
Any function or outside organization as necessary are included in the review pprocess and breifed on the reason(s)
for the proposed change.When approved, the changes are clearely identified in the new document.
- All documents are legible and readily identifiable.
Control of records
- Procedures for identification, storage, protection, retrival, retention time and disposition is established,
documented and maintainedto control records containing information deemed to be relevant to quality and satisfaction of customers'
requirements.
- Data on all quality-related activities are generated and recorded in a meaningful manner ot provide
evidence of quality.
- Records are kept in a suitable environment to protect them from deterioration, damage or loss due to environmental or other conditions.
- A formal system for the disposal of records is established .This system is periodically reviewed.
- The management representatives is responsible for maintaining an accurate list of all records
and establishes specific record locations and document retention cycles.The retention times are established
after considerations of potential product liability, regulatory and statutory requirements.
- Proprietary records are usually not supplied to any customer, or the customer's representative, only if such
disclosure is a contractual requirments. The company may,however, and at its sole discretion,release such information on a case-by-case basis and as needed condition.
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