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2.4

Procedures

The procedure is fundamental in the structure of a Quality Management System. It is a document that carries the management intent to the point of the activity.

Essentially, a procedure describes who does what, where, when, why, and how an activity is to be carried out. When developing procedures, it is important to consider the following:

Traditionally there are two main styles of procedures: The Format of a procedure

A procedure should stipulate clearly, concisely and accurately, only those instructions which are needed for a single activity. Simple, straightforward language, free of vague words and phrase, must be used.

In general, a procedure is a series of related tasks that make up the chronological sequence and the established way of performing work.

Headings and titles, a skillfully selected heading or title will serve to quickly identify the contents of the procedure.

Describe only a single activity, the test of a well written procedure is that it is a series of singular related activities, grouped together in correct operational order to produce one complete task.

Components of a procedure

There are many styles or formats for procedures, but the contemporary style and the most common is the seven part format. Flowcharts are another common method of describing a task and often a combination of both the flowchart and seven part formats is used. It is most important to select the most suitable method for all the users of the procedures.

The Seven Part Procedure

  1. Purpose This will enable the user to determine the purpose of the document, e.g.: to describe the process, to outline the responsibility, to detail the steps.
  2. Scope The scope describes the area and application of the procedure. It details the area of operations or departments, or products which the procedure covers. In this sense, scope can detail both the depth and breadth of application.
  3. Reference Do not repeat another procedure in the activity section of the procedure. To simplify the procedure and keep it free of repetitive information, effective use of a section dealing with references should be made. Any reference that is made to other procedures, manuals, standards, regulations or codes etc., which impact the procedure, or are mentioned in the body of the procedure, should be listed here. Make use of this section, if you repeat another procedure in the activity section, and that procedure changes, then you have to modify and re-issue two (or more) procedures whereas if the said procedure is referred to then you only change one procedure, the referred procedure.
  4. Definitions To avoid misunderstanding, the meanings of terms or words used in the procedure that may not be known are interpreted. Cultural or industry specific jargons are typical examples of definitions found in procedures.
  5. Procedure, action or activity This is the action component of the procedure setting out what is to be done. It should be a sequential description of who will do what, when, where, why and how. The activity described must follow the logical sequence of the activity events.
  6. Documentation A list of forms, labels or registers used or involved during the performance of the procedure. Consider also any documents outside the procedure (i.e. that are not referenced) that need to be taken into account, e.g.: list of standards, codes or guidelines.
  7. Appendix An appendix is used to show sample forms or documents which provide guidance on how they might be completed.

When writing procedures and other documents it is important to use the verb shall and not will. The verb will has an inference of probability, shall has no such ambiguity. Auditors have a habit of looking for this.

Following are three examples of procedures. The first two are examples of layout of the elements only, not content. Note there is no document control (procedure number)
One is for the seven part format. One is for the flowchart format, but still incorporating the seven part format.
The third procedure is an example of how a working finished procedure should look, including issue date, revision number, authorization, and procedure number.
Note; the title page is optional, but dont forget to include a title if not using a title page.
You will notice the similarity with the 'Procedure for Numbering Quality Documents' we have recently shown.

Example 1.

A seven part procedure

1.0 Purpose
The purpose of this procedure is to provide instruction, and to assign responsibility, for controlling, by a systematic sequence of actions, the issue, receipt and withdrawal of all documents and revisions thereto associated with the accomplishment of any work activity and the achievement of quality objectives, specified either by contract or company objectives.

2.0 Scope
This procedure is applicable to all documentation generated as a result of implementing the requirements of either the quality assurance program of the XYZ Company Limited or a quality plan developed by the XYZ Company Limited for a contract.

3.0 References

4.0 Definitions
Documents
Shall include procedures, specifications, drawings, and work instructions, correspondence either individually or collectively.
Procedure
A document detailing the purpose and scope of an activity and specifying by whom and how it is to be properly carried out.

5.0 Procedure
All documents retained in the master file shall be filed in lockable fire resistant filing cabinets.

6.0 Documentation
None

7.0 Appendix
None

All sections should be used, even if it contains no nominative reference. In this case you should enter 'none', as in the example above.

The Flowchart

Using a flowchart is a good method of simplifying a complex process and thus enabling users a quickly identify what is required. It also enables writers of procedures to sequence the major activities before detailing specific requirements for each step. In this way, the flowchart forms a basis for the procedure, but can also be incorporated into the procedure as reinforcement for the written document.

There are other benefits of the flowchart method. It allows continual review of the process and provides a big picture or helicopter view of the activity. However, there are difficulties. Flowcharts can over-simplify the process and may be difficult for non-employees to interpret, especially when non standard symbols are used. Also, when used on their own without supporting documentation, they may lack details. It is for this reason we suggest use a combination of both the seven part format and the flowchart.

Example 2.


A Procedure Layout Combining a Flowchart and the Seven Part Format

Palm Kernel Oil Production Process Procedure

1.0 Purpose
The purpose of this procedure is to describe the stages of the production process for producing crude palm oil.

2.0 Scope
This procedure shall apply from when it starts until storage.

3.0 Reference
None

4.0 Definition
PKO:- Palm kernel oil
PKE:- Palm kernel expeller

5.0 Documentation

  1. Scale note
  2. Truck record book
  3. Production report form no..
6.0 Appendix
None

7.0 Procedure




Example 3.

Procedure for Controlling the Storage and Retention of Quality Records
ABC Ltd
Widget Manufacturer
Document Number Pro-Q-006-R01
Document Title:
Procedure for Controlling the Storage and Retention of Quality Records
Pro-Q-006-R01
Issue Date: 08/04/00
Rev. No.: 01
Rev. Date: 16/08/0
page 1/4
Procedure for Controlling the Storage and Retention of Quality Records

1.0 Purpose
    1.1. The purpose of this procedure is to describe the method for storage, identification, retention time, and disposition of quality records.
2.0 Scope
    2.1. This procedure shall apply to all storage, identification, retention time, and disposition of quality records.
    2.2 This procedure shall apply to all departments that generate quality records.
3.0 Reference
    3.1. - None.
4.0 Definition
    4.1. - Obsolete:
    The term relates to records of completed and delivered product.
5.0 Procedure
    5.1. Each related department shall store quality system records in a readily retrievable manner.

Continued . . . .
Pro-Q-006-R01
Issue Date: 08/04/00
Rev. No.: 01
Rev. Date: 16/08/0
page 2/4
Procedure for Controlling the Storage and Retention of Quality Records
. . . . continued
    5.2. Each related department as necessary shall keep a register of the quality records.
    5.3. All quality system records shall be kept in the related departments according to the retention time.
    5.4. Obsolete quality records shall be stored in boxes. The boxes shall be marked legibly with the type of records, the month and the year that relates production of the record, and stored in the Record Archive Store for minimum of 5 years before being destroyed.
6.0 Documentation
    6.1. Quality records
7.0 Appendix
    7.1. Table 1. Quality records
Pro-Q-006-R01
Issue Date: 08/04/00
Rev. No.: 01
Rev. Date: 16/08/0
page 3/4
Procedure for Controlling the Storage and Retention of Quality Records
Appendix 7.1
Table 1.
Quality Records
   Record Description      Location       Retention  Time  Responsibility   Disposal  Method
Defect Report Production Office Indefinite Production Manager Shred
Batch Report Production Office 7 years Production Manager Shred
Test Report Production Office Indefinite Production Manager Shred
N/C Report Laboratory 3 years Laboratory Manager Shred
Calibration (internal & external) Laboratory Indefinite Laboratory Manager Shred
Purchase Requisition Purchasing Office Indefinite Head of Purchasing Shred
Purchase Order Purchasing Office Indefinite Head of Purchasing Shred
Approved Product List Purchasing Office Indefinite Head of Purchasing Shred
Approved Supplier List Purchasing Office Indefinite Head of Purchasing Shred
Evaluation Supplier Purchasing Office Indefinite Head of Purchasing Shred
Customer Complaint Marketing Office 3 years Marketing Manager Shred
Incoming/outgoing Letter/ Fax Marketing Office 2 year Marketing Manager Shred
Sales Report Marketing Office Indefinite Marketing Manager Shred
Work Order Marketing Office Indefinite Marketing Manager Shred
Quotation Marketing Office Indefinite Marketing Manager Shred
Machine/Equipment Defect Report Maintenance Office 2 years Head of Maintenance Shred
Machine Record Maintenance Office Indefinite Head of Maintenance Book
Drawings Drawing Office Indefinite Head Drafter Shred
Internal Audit Report QA Office 5 years QA Manager Shred
Document Control QA Office Indefinite QA Manager Shred
Revision Record (Procedure & WI) QA Office Indefinite QA Manager Shred
Training Record GP&A. Office Indefinite Adm. Manager Shred
Form no. Q-0061-R00
Pro-Q-006-R01
Issue Date: 08/04/00
Rev. No.: 01
Rev. Date: 16/08/0
page 4/4

Guidance in developing a procedure

  1. Review current practice
    Locate existing documentation (if any), procedures and work instructions relating to the activity to be documented. This includes documents generated both within and outside the organization.

  2. Analyses of current practice
    Is the current practice suitable to achieve objectives or specified requirements? If the current practice is indeed adequate, current procedures need only be brought under document control. In the absence of written procedures then document the activity and bring under document control

  3. Develop a draft procedure
    Using the agreed format, develop a draft procedure, documenting the method by which the activity is (or is to be) carried out. If appropriate, define responsibilities and authorities, reference out to work instructions and/ or include an appendix.
A suggested approach to develop a draft procedure is:
  1. Identify the action to be covered by the procedure. Before starting to write, it is essential to have a clear view of what is to be detailed.
  2. Agree on a title for the procedure. This will help the writer to focus on the specific action. Ensure that the title is descriptive of the action being performed.
  3. Determine the purpose and scope of application for the procedure. By determining who and where the procedure will be issued, the writer is able to use the language and style suitable to the users.
  4. Determine the major activities that comprise the action to be documented. Try to visualize the procedure being performed, or if possible, observe someone performing the task. Identify the major steps only at this stage. What is important here, is sequence.

DO consult the individuals who are carrying out the activity and be sure to make sure they do not feel threatened by the questioning. During this determination it is amazing how many times management has found that the procedure, or parts of the procedure in use is not what was expected, even in small companies.

  1. Release draft for comment
    This step, step 5 and step 6, are paramount to achieving acceptance and adherence to the procedure when it is finally implemented. Consider the following:
    • Consider using a form for comments.
    • Set a timeframe for feedback.
    • Who will review the draft? Just those it applies to, or other interested parties?
    • Does the procedure accurately describe the activity?
    • Is it easy to read, understand and follow?
    • Are there any suggestions for improvement?
    • Does the procedure use the jargon of the activity appropriately?

  2. Review comments
    With the aid of appropriate personnel, supervisors or works teams, review the comments to determine those which should be acted upon. Pay particular attention to comments made by the specific individuals who will be using the procedure. Incorporating their ideas into the procedure will facilitate worker ownership of both the procedure and the outcome of that procedure.

  3. Revise, test, & issue procedure for acceptance
    Incorporate those comments which are considered appropriate and distribute the reviewed procedure to all involved personnel for final agreement.

    Procedure Testing

    It can be useful at this stage to test the suitability of the written procedure by staging a simulation. Locate an employee with the appropriate experience and training to perform the activity. Ensure that they have not had direct involvement with the development of the procedure, and have had little or no previous involvement with the activity.

    Note any problem indicators and where they occurred.
    Problem indicators

    • Mistakes in performance of the activity.
    • Nonconforming end product or service.
    • Flicking to and fro, from page to page.
    • Re-reading sections, passages or sentences.
    • Furrowed brow.
    • Persistent questioning.

  4. Obtain approval
    Once agreement has been reached on the final draft, ensure procedure has been checked by the responsible nominated person. Then submit the procedure to appropriate personnel for approval prior to issue.

  5. Issue the procedure
    Issue the procedure to all relevant personnel. This doesnt necessarily imply that all concerned should receive an individual copy. In the instances where a number of people will use the same procedure, ready access to the procedure should be sufficient. Procedures should be issued under controlled conditions.

  6. Implement the procedure
    Ensure that those who will be using the procedure receive adequate:
    • Briefing on the new procedure; and/ or
    • Training on the new procedure if it describes new work activities.
    • All involved personnel need to be familiar with the contents and methods of application.

  7. Monitor and review
    Audit the implementation of the procedure to verify effectiveness and adherence. The audit of the procedure could be conducted for one hour, one week, or one month, after implementation, depending upon the potential for risk and impact of nonconformance.

    The formats we have shown are the most accepted formats. They first two are only examples of the format of layout and not examples of actual procedures. The third is an example of an actual procedure. If you have your own format and it complies with all criteria of the standard then feel free to use it.
    In order to maintain consistency you can publish as your one of your first procedures the Procedure for Documenting Procedures. Any employee then tasked with developing a new procedure or documenting an original procedure shall follow a standard format.

Once you have decided on the format you will be using for your procedures you can firstly document your Identification and Numbering System as a procedure and secondly document a procedure for writing procedures. This can then be used by everyone writing procedures.

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