When an Sop Is Submitted for Peer Review Army

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two STANDARD OPERATING PROCEDURES

two.i Definition
2.2 Initiating a SOP
ii.3 Grooming of SOPs
2.4 Administration, Distribution, Implementation
2.v Laboratory notebook
2.vi Relativization as encouragement
SOPs

2.1 Definition

An important attribute of a quality organisation is to work co-ordinate to unambiguous Standard Operating Procedures (SOPs). In fact the whole process from sampling to the filing of the analytical event should be described by a continuous series of SOPs. A SOP for a laboratory can be defined as follows:

"A Standard Operating Procedure is a document which describes the regularly recurring operations relevant to the quality of the investigation. The purpose of a SOP is to deport out the operations correctly and always in the aforementioned mode. A SOP should be available at the place where the work is done".

A SOP is a compulsory teaching. If deviations from this teaching are immune, the atmospheric condition for these should be documented including who can give permission for this and what exactly the consummate procedure will exist. The original should rest at a secure identify while working copies should exist authenticated with stamps and/or signatures of authorized persons.

Several categories and types of SOPs tin be distinguished. The name "SOP" may not ever exist appropriate, east.one thousand., the description of situations or other matters may better designated protocols, instructions or simply registration forms. Also worksheets belonging to an analytical procedure have to be standardized (to avoid jotting downwardly readings and calculations on odd pieces of paper).

A number of important SOP types are:

- Fundamental SOPs. These give instructions how to make SOPs of the other categories.
- Methodic SOPs. These describe a consummate testing system or method of investigation.
- SOPs for safety precautions.
- Standard procedures for operating instruments, appliance and other equipment.
- SOPs for analytical methods.
- SOPs for the training of reagents.
- SOPs for receiving and registration of samples.
- SOPs for Quality Assurance.
- SOPs for archiving and how to bargain with complaints.

2.2 Initiating a SOP

As implied above, the initiative and further procedure for the preparation, implementation and management of the documents is a procedure in itself which should be described. These SOPs should at least mention:

a. who can or should brand which type of SOP;
b. to whom proposals for a SOP should exist submitted, and who adjudges the draft;
c. the procedure of approval;
d. who decides on the engagement of implementation, and who should be informed;
due east. how revisions can be made or how a SOP can be withdrawn.

Information technology should exist established and recorded who is responsible for the proper distribution of the documents, the filing and assistants (e.g. of the original and farther copies). Finally, it should be indicated how oftentimes a valid SOP should be periodically evaluated (usually ii years) and by whom. But officially issued copies may be used, only then the use of the proper educational activity is guaranteed.

In the laboratory the process for the preparation of a SOP should be as follows:

The Head of Laboratory (HoL) charges a staff fellow member of the laboratory to draft a SOP (or the HoL does this himself or a staff fellow member takes the initiative). In principle, the writer is the person who will work with the SOP, simply he or she should always go along in listen that the SOP needs to be understood by others. The author requests a new registration number from the SOP administrator or custodian (which in smaller institutes or laboratories will often be the HoL, see two.iv). The administrator verifies if the SOP already exists (or is drafted). If the SOP does not exist still, the championship and author are entered into the registration system. Once the writing of a SOP is undertaken, the management must actively support this endeavour and allow authors adequate preparation time.

In case of methodic or apparatus SOPs the author asks one or more qualified colleagues to try out the SOP. In case of execution procedures for investigations or protocols, the project leader or HoL could do the testing. In this stage the wording of the SOP is fine-tuned. When the test is passed, the SOP is submitted to the SOP administrator for acceptance. Revisions of SOPs follow the same procedure.

two.3 Preparation of SOPs

The make-up of the documents should meet a minimum number of requirements:

1. Each page should have a heading and/or ground mentioning:
a. date of blessing and/or version number;
b. a unique title (abbreviated if desired);
c. the number of the SOP (preferably with category);
d. page number and total number of pages of the SOP.
e. the heading (or only the logo) of originals should preferably be printed in another colour than blackness.

Categories can be denoted with a letter or combination of letters, east.g.:

- F for central SOP
- A or APP for apparatus SOP
- M or METH for analytical method SOP
- P or PROJ for procedure to carry out a special investigation (projection)
- PROT for a protocol describing a sequence of actions or operations
- ORG for an organizational certificate
- PERS for describing personnel matters
- RF for registration form (e.g. chemicals, samples)
- WS for worksheet (related to analytical procedures)
2. The first folio, the title page, should mention:

a. general data mentioned under 2.3.i to a higher place, including the consummate title;
b. a summary of the contents with purpose and field of application (if these are non evident from the title); if
desired the principle may be given, including a list of points that may need attention;

c. any related SOPs (of operations used in the nowadays SOP);

d. possible condom instructions;

e. proper noun and signature of author, including date of signing. (It is possible to record the authors centrally in a register);

f. name and signature of person who authorizes the introduction of the SOP (including date).

3. The necessary equipment, reagents (including grade) and other ways should be detailed.

4. A clear, unambiguous imperative clarification is given in a language mastered by the user.

5. Information technology is recommended to include criteria for the control of the described organisation during operation.

six. It is recommended to include a list of contents particularly if the SOP is lengthy.

seven. It is recommended to include a list of references.

2.4 Assistants, Distribution, Implementation

From this description information technology would seem that the preparation and administration of a SOP and other quality balls documentation is an onerous task. However, in one case the typhoon is made, with the use of word processors and a simple distribution scheme of persons and departments involved, the job tin exist considerably eased.

A model for a simple preparation and distribution scheme is given in Figure 2-ane. This is a relation matrix which can not simply be used for the laboratory merely for any department or a whole institute. In this matrix (which tin can be given the status of a SOP) can be indicated all persons or departments that are involved with the bailiwick besides equally the kind of their involvement. This can be indicated in the scheme with an involvement code. Some of the most usual involvements are (the number can exist used as the code):

i. Taking initiative for drafting
2. Drafting the document
iii. Verifying
4. Authorizing
5. Implementing/using
6. Copy for information
seven. Checking implementation
8. Archiving

Fig. two-one. Matrix of information organization (see text).

There is a multitude of valid approaches for distribution of SOPs only there must always be a mechanism for informing potential users that a new SOP has been written or that an existing SOP has been revised or withdrawn.

It is worthwhile to prepare a practiced filing system for all documents right at the showtime. This will spare much inconvenience, defoliation and embarrassment, non only in internal use merely also with respect to the institute'south management, authorities, clients and, if applicative, inspectors of the accreditation body.

The ambassador responsible for distribution and archiving SOPs may differ per found. In large institutes or institutes with an accredited laboratory this will exist the Quality Assurance Officer, otherwise this may be an officer of the department of Personnel & Organization or still someone else. In non-accredited laboratories the administration can most conveniently be done by the head of laboratory or his deputy. The assistants may be done in a logbook, by means of a card system or, more conveniently, with a computerized database such equally PerfectView or Cardbox. Suspending files are very useful for keeping originals, copies and other information of documents. The nearly logic system seems to brand an appropriate grouping into categories and a chief alphabetize for easy retrieval. Information technology is most convenient to keep these files at a fundamental place such equally the office of the head of laboratory. Naturally, this does not use to working documents that obviously are used at the work place in the laboratory, e.one thousand., instrument logbooks, operation teaching manuals and laboratory notebooks.

The information which should exist stored per document are:

- SOP number
- version number
- date of issue
- engagement of expiry
- championship
- writer
- status (title submitted; being drafted; typhoon ready; issued)
- department of holders/users
- names of holders
- number of copies per holder if this is more than one
- registration number of SOPs to which reference is fabricated
- historical information (dates of previous issues)

The SOP administrator keeps at least two copies of each SOP; one for the historical and i for the redundancy file. This also applies to revised versions. Superseded versions should be collected and destroyed (except the copy for the historical file) to avoid confusion and unauthorized use.

Examples of various categories of SOPs will be given in the ensuing chapters. The contents of a SOP for the administration and management of SOPs tin can exist distilled from the above. An instance of the basic format is given as Model F 002.

2.5 Laboratory notebook

Unless recorded automatically, raw data and readings of measurements are most conveniently written downwards on worksheets that can be prepared for each analytical method or procedure, including calibration of equipment. In addition, each laboratory staff fellow member should have a personal Notebook in which all observations, remarks, calculations and other actions connected with the work are recorded in ink, not with a pencil, then that they will not be erased or lost. To ensure integrity such a notebook must meet a few minimum requirements: on the cover it must deport a unique serial number, the possessor's proper noun, and the date of issue. The copy is issued past the QA officer or head of laboratory who keeps a record of this (eastward.g. in his/her own Notebook). The user signs for receipt, the QA officer or HoL for issue. The Notebook should be jump and the pages numbered before issue (loose-leafage bindings are not GLP!). The first i or 2 pages can be used for an index of contents (to be filled in equally the book is used). Such Notebooks can made from ordinary notebooks on sale (before result, the folio numbering should and then be done by manus or with a special stamp) or with the help of a word processor and then printed and jump in a graphical workshop.

The instructions for the proper employ of a laboratory notebook should be ready down in a protocol, an case is given as Model PROT 005. A model for the pages in a laboratory notebook is given.

two.half-dozen Relativization as encouragement

In the Preface information technology was stated that documentation should not be overdone and that for the implementation of all new Quality Management rules the philosophy of a step-by-stride approach should be adopted. It is emphasized that protocols and SOPs, every bit well as the administration involved, should be kept equally simple as possible, specially in the beginning. The Quality Management arrangement must grow by trial and error, with increasing feel, by grouping discussions and with changing perceptions. In the beginning, attending will be focused on bones operational SOPs, later shifting to record keeping (equally more and more than SOPs are issued) and filling gaps every bit practice reveals missing links in the concatenation of Quality Balls. Inevitably bug will turn up. One way to solve them is to talk with people in other laboratories who have faced similar problems.

Practice not forget that Quality Management is a tool rather than a goal. The goal is quality operation of the laboratory.

SOPs

F 002 - Administration of Standard Operating Procedures
PROT 005 - The Apply of Laboratory Notebooks
Model page of Laboratory Notebook

F 002 - Administration of Standard Operating Procedures

LOGO	STANDARD OPERATING PROCEDURE		Page: 1 # 2
	Model: F 002	Version: 1	Engagement: 95-06-21
	Title: Administration of Standard Operating Procedures		File:

1. PURPOSE

To give unambiguous instruction for proper management and administration of Standard Operating Procedures every bit they are used in the Regional Soil Survey Institute (RSSI).

ii . PRINCIPLE

Standard Operating Procedures are an essential part of a quality arrangement. For all jobs and duties relevant operating procedures should be available at the piece of work station. To guarantee that the correct version of the instruction is used copying Standard Operating Procedures is prohibited. Standard Operating Procedures are issued on paper with the heading printed in green.

3. FIELD OF APPLICATION

Generally for use in the quality organization of RSSI but more specifically this didactics is for apply in the Chemical science Department.

4. RELATED SOPs

- F 011	The preparation of SOPs for apparatus
- F 012	The preparation of SOPs for methods
- PROJ 001	The preparation of SOPs for special investigations

5. REQUIREMENTS

Database computer plan, PerfectView or Cardbox

half-dozen. Procedure

6.1 Assistants

The administration of SOPs for the Chemistry Department tin can be washed by the Head of Laboratory.

6.2 Initiating new SOP

(Run into these Guidelines, 2.2)

six.3 Revision of SOPs

(see these Guidelines, two.ii)

Author:	Sign.:
QA Officer (sign.):	Engagement of Decease:

6.v Distribution of SOPs

When the Sop fulfils all the necessary requirements it is printed. The author hands over the manuscript (or the floppy disk with text) to the SOP administrator who is responsible for the printing. The number of copies is decided by him/her and the author. Make matrix of distribution (see Guidelines for Quality Management Fig. ii-1).

The writer (or his successor) signs all copies in the presence of the administrator before distribution. Equally the new copies are distributed the old ones (if there was one) are taken in. For each SOP a list of holders is made. The holder signs for receipt of a re-create. The list is kept with the spare copies.

Copying SOPs is forbidden. Actress copies can be obtained from the SOP administrator.

Users are responsible for proper keeping of the SOPs. If necessary, copies tin be protected by a cover or foil, and/or be kept in a loose-leaf binding.

vii. ARCHIVING

Proper archiving is essential for proficient administration of SOPs. All operating instructions should be kept upward-to-date and be accesible to personnel. Skillful Laboratory Practise requires that all documentation pertaining to a test or investigation should be kept for a certain menses. SOPs belong to this documentation.

viii. REFERENCES

Mention here the used Standards and other references for this SOP.

PROT 005 - The Use of Laboratory Notebooks

LOGO	STANDARD OPERATING Procedure		Folio: 1 # two
	Model: F 002	Version: 1	Appointment: 95-11-28
	Title: The Utilize of Laboratory Notebooks		File:

1. PURPOSE

To requite didactics for proper lay-out, employ and administration of Laboratory Notebooks in order to guarantee the integrity and retrievability of raw data (if no preprinted Work Sheets are used), calculations and notes pertaining to the laboratory work.

2. PRINCIPLE

Laboratory Notebooks may either be issued to persons for personal utilise or to Study Projects for common use by participating persons. They are used to write downwardly observations, remarks, calculations and other deportment in connection with the work. They may be used for raw data but bound preprinted Work Sheets are preferred for this.

3. RELATED SOPs

F 001	Administration of SOPs
PROJ 001	The preparation of SOPs for Special Investigations

4. REQUIREMENTS

Leap notebooks with virtually 100-150 consecutively numbered pages. Any bounden which cannot be opened is suitable; a spiral binding is very convenient.

Both ruled and squared newspaper can be used. On each folio provisions for dating and signing for entries, and signing for verification or inspection may be made.

v. Process

5.i Issue

Notebooks are issued by or on behalf of the Caput of Laboratory who keeps a record of the books in apportionment (this record may have a format similar to a Laboratory Notebook or be part of the HoL'due south own Notebook).

On the cover, the book is marked with an assigned (if non preprinted) serial number and the name of the user (or of the project). On the inside of the comprehend the HoL writes the date of issue and signs for consequence. The user (or Project Leader) signs the circulation tape for receipt.

5.2 Use

All entries are dated and fabricated in ink. The person who makes the entry signs per entry (in project notebooks) or at least per page (in personal notebooks). The Head of Laboratory (and/or Project Leader) may inspect or verify entries and pages and may sign for this on the page(south) concerned.

If entries are corrected, this should exist lined out with a single line and then that it is possible to meet what has been corrected. Essential corrections should be initialed and dated and the reason for correction stated. Pages may not be removed; if necessary, a whole page may exist deleted by a diagonal line.

Author:	Sign.:
QA Officer (sign.):	Date of Expiry:

five.3 Withdrawal

When fall, the Notebook is exchanged for a new i. The HoL is responsible for proper archiving. A notebook belonging to a Study Project is withdrawn when the report is completed.

When an employee leaves the laboratory for another postal service (south)he should hand in her/his notebook to the HoL

6. ARCHIVING

The Head of Laboratory is custodian of the withdrawn Laboratory Notebooks. They must remain accessible for inspection and audit abaft,

7. REFERENCES