7- Documentation Copyrights© Productivity & Quality Institute DR. MAGDY YOUSSEF §:Document Siructure 1. Procedures 2. Work instruction 2. Reference documentation 4 Record s. Job description Copyright© Productivity & Quality Institute DR. MAGDY YOUSSEF IProcedure a © Procedures are needed where the process is >» critical and there are > interfaces between activities ( tasks ) > involving different people. © Procedure describe : > The purpose of the process > Who is responsible for doing what, when, where and why it must be done if necessary > They can also state how the performance of the process is being measured 2 5 An organization should be able to use the procedure an as educational tool to inform the employees of the correct method of working Copyrights Productivity & Quality Institute DR. MAGDY YOUSSEF NSWork instructions a a Where an activity (task) is critical a work instruction specifies the details requirement for a single operation , Oo Including : > Task involved How these should be performed » The standards to be used. Y a Locally developed and owned. 3 Relate to one particular activity. 2 Do not need to follow consistent format. Copyright© Productivity & Quality Institute DR. MAGDY YOUSSEF NSReference documentation a 2 The documentation that needs to be consulted in order to follow a procedure or work instruction, specially if there are not fully comprehensive and therefore reference material may be used © Typically , these are manufacture's guidelines, codes of practice , legislative requirement and equipment handbook © They can simply expressed as input documents to the process Copyright© Productivity & Quality Institute DR. MAGDY YOUSSEF NeRecords 0 They are the forms generated by applying the procedure or work instruction to the process. oO There are simply output documents from the process O They demonstrate achievement of the required quality and the effective operation of the quality system © They provide objective evidence on how the quality system is functioning Copyright© Productivity & Quality Institute DR. MAGDY YOUSSEF NeJob description Job descriptions define the is ibili * Identification * Essential Functions and > Responsibility Stan Sues » Authority, > Reporting relationships > Lists major tasks, duties and > Department responsibities » Reporting and * Location + Job Specifications > Date of analysis, > Knowledge, skils, and » Interfacing * General Summary pees pte ee + > Describes the job's lucation and experience relationships which sina eS nssties > Physical regirerans exist for a particular ‘and components position in the * Signature of approvals organization Copyrights© Productivity & Quality Institute DR. MAGDY YOUSSEFDeveloping policy , procedure and work instruction Copyright© Productivity & Quality Institute DR. MAGDY YOUSSEF q:;Contents 1. DEVELOPING PROCEDURE 2. DEVELOPIMG WORK INSTRUCTION 3. CONTROLLING THE DOCUMENT Copyright© Productivity & Quality Institute DR. MAGDY YOUSSEF1 - Developing a procedure 10 Review current practice the process must be able to meet its requirement if not either practice or requirement must change. Review current system documentation. Determine whether one procedure per process is enough consider length and complexity of process or activity. Number of interface. Drafting a procedure is normally the responsibility of the process owner. There is no specific rule for when document should be reissued. Copyright© Productivity & Quality Institute DR. MAGDY YOUSSEFA thorough analysis of your readers’ needs before you write is critical Comments need to be obtained from The people responsible for the activities in the procedure. People affected by the procedure. The quality coordinator You need to go through the circular process of writing, editing, and re-writing until your manual meets the needs of the staff of your organization. Work hard and take the time to prepare a well written and attractive document. Clear writing does not just happen. You must make it happen! When you edit polices, make changes that promote the three Cs: clarity, conciseness, and coherence Copyrights Productivity & Quality Institute DR. MAGDY YOUSSEF NSO) The procedure should be checked for language, layout and consistency. > Factual—double-check accuracy! > — Include chronological step-by-step instructions for completing . > Not too technical—simple enough to be understood by a new employee U1 It should be approved for issue by the person for the overall system. Q Training employees in the area of policy is very important, they may need to see and hear a presentation — an interactive experience ASS = Copyrights© Productivity & Quality Institute DR. MAGDY YOUSSEF NeProcedure content * Purpose. * Scope. * References. * Definitions. * The procedure. * Record 13 Copyrights© Productivity & Quality Institute DR. MAGDY YOUSSEFPurpose * The process's purpose is a simple statement, usually —one- sentence, describing what the process is supposed to accomplish for the company. * You need to carefully analyze every word to make sure that the purpose statement truly describes-in simple and fundamental terms-what the process is supposed to accomplish. 14 Copyright© Productivity & Quality Institute DR. MAGDY YOUSSEF xScope * The scope must be performed before we begin to define the process details. * Usually several option for where process begins and ends Copyrights© Productivity & Quality Institute DR. MAGDY YOUSSEFReference documentation + Documents which the user might need in order to follow the procedure ¢ Input to the process * Not generated by the process 16 Copyright© Productivity & Quality Institute DR. MAGDY YOUSSEFDefinitions * Words abbre Ns or acronyms ambiguous not readily understood , Include definitions where necessary. Need to be clear about where there is potential for ambiguity or misunderstanding. When preparing this section careful consideration must be taken of the knowledge of future readers of the procedure. “SEecibus level in time oF space: ‘Synonyms: alfiance, assistance, 0 coalition, co confederation; in science, technolo} swith reference to the ¢ 7 Copyrights© Productivity & Quality Institute fee DR. MAGDY YOUSSEFThe “Procedure” The active part of the documents. Outlines who has the responsibility for doing what, when and where. Describe the actions necessary for the process or activity meeting its requirements. Developing and writing the procedure follows on from flowcharting the process. Being able to easily convert the requirements into questions facilities the development of audit checklists. Copyrights Productivity & Quality Institute DR. MAGDY YOUSSEF Ns* Only convey one idea per sentence. * Only convey one theme per paragraph. * Make the procedure simple to follow, by using the simplest language that will convey the idea. * Cross refer to documentation; generated by the process which will be referenced in the records section how to 9 Copyrights© Productivity & Quality Institute DR. MAGDY YOUSSEF NSQuality record * Should contain a list of all records generated as a result of applying the procedure to the process. * The information captured in the record is output from the process. * Quality records provided evidence on how the procedure is being applied to the process. * Where appropriate blank examples of the forms may be attached Copyrights© Productivity & Quality Institute DR. MAGDY YOUSSEF < “aus2. Developing work instructions * The depth to which the instruction goes should be compatible with the task being performed and the skills of the person carrying it out * Instructions can exist in many different formats and styles ,They may take the form of detailed, step by step instructions of what to do or sometimes simple diagrams or symbols to convey the message. 21 Copyright© Productivity & Quality Institute DR. MAGDY YOUSSEFContent of Instructions Effective instructions should consist of = Y The title clearly defining the task to be undertaken. Y The job of the individual for doing the task. Y Clear steps of how to perform the task. v Any input documents required to carry out the task, for example, reference documents, reports, etc. v The output that provide objective evidence of the task completion, for example, record, forms, documentation 22 Copyright© Productivity & Quality Institute DR. MAGDY YOUSSEF3. Controlling the document * It is important that quality system documentation is seen as a useful tool and living document that are well known and referred willingly. * Plan how the documentation is to be issued, administrated and controlled : > Identify for whom the information needs to be communicated and plan how to do it. Have a system for identifying the documents. Assign who is responsible for authorizing, issuing and distributing documentation. Establish distribution control. Plan control of amendments and revisions. Amendments and revision must be approved and authorized by the nominated individual. vv VVV 23 Copyright© Productivity & Quality Institute DR. MAGDY YOUSSEFTransmittal document * It is vital that obsolete copies are destroyed and/or removed from circulation. * Transmittal document serves as a record that distribution of controlled documents has been done in accordance with the procedure Copyright© Productivity & Quality Institute DR. MAGDY YOUSSEFlity Institute DR. MAGDY YOUSSEF