Record keeping requirements.

Content

1. Purpose and scope……………………………………………………..3

2. Terms and symbols………………………………………………………………………….3

3. Quality records management……………………………………………………………….4

4. Record keeping requirements………………………………………………………………….6

5. Parameters and monitoring of the process.………………………………………………….…………8

6. Archives…………………………………………………………………………………………..8

7. Appendix 1 Records by quality …………………………………………………………………9

8. Appendix 2 Quality Records Management …………………………………………12

15

Purpose and scope.

1.1. This documented procedure applies to all departments of the FBUZ Center for Hygiene and Epidemiology in the Karachay-Cherkess Republic, whose activities are subject to the quality system. This procedure has been developed in accordance with GOST R ISO / IEC 17025 and GOST R ISO / IEC 9001.

1.2. The documented procedure specifies the requirements for the control of quality records.

1.3. Quality records – documents that provide objective evidence of the work done or the results achieved, in particular, evidence of the degree of fulfillment of the requirements for the quality of studies (measurements) or evidence of the effectiveness of the system (Appendix 1).

1.4. Quality records are reports, acts, protocols, logs and other documents compiled by performers in the course of production processes. They serve as the basis for subsequent analysis, which allows to identify trends in quality indicators, assess the causes of various inconsistencies, prescribe corrective actions, and determine their effectiveness.

Terms and notation

· GOST ISO 9000 – 2011 “Quality management systems. Basic provisions and vocabulary”;

· GOST ISO/IEC 17025 – 2009 “General requirements for the competence of testing and calibration laboratories”;

· GOST ISO 9001-2011 “Quality management systems. Requirements”;

· DP 02.01.01.2015 “Documentation Management”.

Term Definition of the term
Document Information recorded on a material carrier with details that allow it to be identified
Document flow The movement of documents in the organization from the moment they are created or received until the completion of execution or dispatch
Records by quality Documents that provide objective evidence of the work done or the results achieved, in particular, evidence of the degree of fulfillment of the requirements for the quality of studies (measurements) or evidence of the effectiveness of the system
Objective evidence Data that confirms the existence or truth of something. Objective evidence can be obtained by measurement, testing, observation
Regulatory document A document that establishes rules, general principles, or characteristics relating to various activities or their results

Quality records management

3.1. Controlled documents are those whose preparation, identification, review, approval, distribution, storage and revision are carried out on the basis of pre-established, systematically used rules.

3.2. Documents are executed both in paper and electronic form and are presented both in discrete (text, digital) and analog (nomogram, spectrum) form.

3.3. The records management processes are:

– registration of quality data;

– processing of quality data;

– quality data analysis;

– storage of quality data for a specified period;

– withdrawal and destruction of quality data after the expiration of the storage period.

3.4. Records management includes the collection, identification, analysis, protection, storage and withdrawal of relevant records for all QMS processes.

3.5. Records management is aimed at organizing information processes that ensure the timely and regular provision of management and all interested parties with complete and reliable information necessary and sufficient to make informed decisions on improving processes and increasing the effectiveness of the QMS.

3.6. Quality records allow you to:

– have a set of quality data for a certain period of time;

– timely identify all kinds of inconsistencies;

– identify the causes of nonconformities, take corrective and preventive actions.

3.7. A general description of the Quality Records Management process, in accordance with the goal, is presented in the form of a context diagram – Figure 1.

Picture 1.

PROCESS DESCRIPTION

ISO 9001:2011, DP

ISO 9001:2011, DP “Management” Internal

ISO 9001:2011 audit documentation”

Determining the type and format of records

Templates

and and forms

Registration and identification

Weekend

record data

results Recordings by

Seizure and control

quality

(QMS processes) (QMS processes)

Protection and storage

Entries

Withdrawal

records

Leaders

structural

Department Process Owners

3.8. The sequence of actions, levels of responsibility and time parameters of the Quality Records Management process in Annex 3 to this Documented Procedure.

Record keeping requirements.

4.1. Paper magazines.

4.1.1. Journals / forms must be entered in the register of the unit.

4.1.2. Journals/forms are identified by:

– by identification number, consisting of the form number, document level, subdivision number, year of publication – separated by a dash:

Form number level Department number The year of publishing
F01

For example: F01-04-02-2015

– name

– date of establishment and graduation.

4.1.3. Magazines should be laced, numbered.

4.1.4. All columns of the log must be filled in (if in some case there is no need to fill in the column, then a dash is put or the reason is written).

4.1.5. Pencil entries are not allowed.

4.1.6. Corrections must be made only by crossing out incorrectly entered information and writing the correct data on top with the obligatory signature of the person who made the corrections and the date the correction was made.

4.1.7. Entries must be legible.

4.1.8. The dates in the journals are full, i.e. day month Year.

4.1.9. If several entries are made on the same day, then the dates are placed opposite each (where there is a risk of ambiguous interpretation of the entries to which date one or another belongs)

4.1.10. Approved templates of journals, which are kept by the head of the unit in printed and electronic form, should be used.

4.1.11. You need to sign with the full surname or in the journal there should be samples of signatures, where the full name is deciphered. and the position of all who sign in this journal.

4.1.12. The conditions for storing logs in the department should ensure their safety, the absence of damage and the prevention of damage during the entire period of storage.

4.1.13. The correctness of logging should be controlled by the heads of structural divisions with a certain frequency, a mark is made on the pages of the journal (through all columns it is necessary to write: Checked. Date of verification. Position, signature, transcript of the signature).

4.2. Protocols of laboratory researches (measurements).

4.2.1. The form of the protocol is approved by the chief physician.

4.2.2. The title page of the protocol indicates the name of the institution, legal address, telephone number, number and validity period of the accreditation certificate.

4.2.3. The protocol must contain the following information: the name of the sample (sample), who sent the sample (sample), the date and time of sampling and delivery of the sample (sample), the purpose of sampling, the legal entity or individual from whom the sample (sample) was taken, the facility where sampling, sample (sample) code, manufacturer, date of manufacture, packaging, ND for the sampling procedure, transportation conditions, storage conditions, additional information, the person responsible for the protocol, the head of the laboratory, the head of the ILC.

4.2.4. The research protocol should include the following columns:

– No. p / p;

– determined indicators;

– research results;

– units;

– hygienic standard or the value of the permissible level;

– RD for research methods.

4.2.5. The form of the protocol for measuring the levels of physical factors of non-ionizing radiation should contain:

– date and time of measurements;

– name and address of the facility where measurements were taken;

– purpose of measurements;

– measurements were carried out in the presence of a representative of the object;

– name of measuring instruments and information on state verification;

– regulatory and technical documentation, in accordance with which the measurements were carried out and the conclusion was given;

– sources of physical factors and their characteristics;

– a sketch of the premises (territory, workplace) or a description of the location of the measurement points;

– measurement results (measured parameter, units of measurement, measurement results, measurement error);

– additional information;

– conclusion.

4.3. Electronic records.

4.3.1. Quality records made in electronic form must be archived annually and stored for a year from the date of their creation on the division’s servers.

4.3.2. The officials responsible for keeping records are responsible for the safety and correctness of keeping records:

– all columns of the journal must be filled in (if in some case there is no need to fill in the column, then a dash is put or the reason is written);

– the dates in the journals are full, i.e. day month Year;

– approved log templates should be used (may be approved in instructions or documented procedures of departments).

Be First to Comment

Leave a Reply

Your email address will not be published.