How to write standard operating procedures

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…..Serving you better Writing Sta nd a rd Operating Procedu res a nd Job Work Instructions This module was dev eloped by Business Process Improvement. For more modules, pleas e contact us at 281-304- 9504 or visit our website www.spcforexcel.com

Transcript of How to write standard operating procedures

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Writ ing Standard

Operat ing

Procedu res and

Job Work

Instruct ions

This module was developed by Business Process Improvement. For more modules, please contact us at 281-304-9504 or visit our website www.spcforexcel.com

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In t roduct ion

• One of the easiest ways to reduce

variation in a process is to

standardize the way everyone

operates the process.

• Standard Operating Procedures

(SOPs) and Job Work Instructions(JWIs) help standardize the way a

process is operated.

 –  A Process Map is created.

 – The boxes of the Process Map (PM)come to represent the SOPs for the

process.

 – Detailed descriptions of how to do each

box of the PM become the JWIs/SOPs

for the process.

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In t roduct ion

• The SOPs and JWIs are created

by the "best of class" associateswho operate the process -- those

associates who perform best in the

process.

• These "best of class" associatescome together to pool their

knowledge and document the best

way to operate the process as it

now stands.

•  Any obvious areas needing

improvement are addressed in this

model, but overall process

improvement is not addressed with

this model.

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Model for

DevelopingSOPs/JWIs

Meet withthose closestto the process 

Determine thestarting and

ending pointsof the process 

Develop the macro process map by sketching out thesteps in the process 

Does everyoneagree with themacro processmap? 

 Number thesteps in the

macro processmap 

Write the standard

operating procedure and job work instructions for

the process using thecontrolled document

format 

Continuediscussion

until everyoneagrees 

Yes 

 No 

Step.1  Step.2  Step.3 

Step.4 

Step.5 

Step.6  Step.7 

For each step in themacro process flowdiagram, write thedetailed instructions for

how the step is done(job work instructions) 

Does everyoneagree with the job

workinstructions? 

Continuediscussion

until everyoneagrees 

Are thereobvious areaswhere the

 process can beimproved? 

Make thechanges to the

 procedure 

 No 

Yes 

Step.8 

Step.9 Step.10 Step.12 

Step.11 

Meet withthose closestto the process 

Meet withthose closest

to the process 

Determine thestarting and

ending pointsof the process 

Determine thestarting and

ending pointsof the process 

Develop the macro process map by sketching out thesteps in the process 

Develop the Process

By sketching out the

steps involved in the

 process

Does everyoneagree with themacro processmap? 

Does everyoneagree with theProcess map

 Number thesteps in the

macro processmap 

 Number thesteps in the

Process map 

Write the standard

operating procedure and job work instructions for

the process using thecontrolled document

format 

Write the standard

operating procedure / job work instructions for

the process using thecontrolled document

format 

Continuediscussion

until everyoneagrees 

Continuediscussion

until everyoneagrees 

Yes 

 No 

Step.1  Step.2  Step.3 

Step.4 

Step.5 

Step.6  Step.7 

For each step in themacro process flowdiagram, write thedetailed instructions for

how the step is done(job work instructions) 

For each step in the process map write the 

detailed instructions forhow the step is done

(job work instructions) 

Does everyoneagree with the job

workinstructions? 

Does everyoneagree with the job

workinstructions? 

Continuediscussion

until everyoneagrees 

Continuediscussion

until everyoneagrees 

Are thereobvious areaswhere the

 process can beimproved? 

Are thereobvious areaswhere the

 process can beimproved? 

Make thechanges to the

 procedure 

Make thechanges to the

 procedure 

 No 

Yes 

Step.8 

Step.9 Step.10 Step.12 

Step.11 

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Model for Develop ing SOPs/JWIs

• This model is usedwhen:

 – We need to document

the way a job process

should work.

 – We need for all

associates to do the

process the same way,

• Each step of the model

is described in detail inthe following slides.

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Step 1: Meet With Peop le Closest to the

Process

• Developing accurate SOPs and JWIs requires input

from people who work in the process.

•  Associates need to understand the purpose for

creating SOPs and JWIs.

• Associates who are “best of class” should be

selected to participate in writing the SOPs and JWIs.

• Make sure that time are set a side, where associates

will not be interrupted, and will be able to focus on

the task at hand.

Output  = A team of associates selected who are “best of

class” for the process to help develop the SOPs and JWIs. 

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Step 2: Determ ine the Starting And End ing

Point

• The Team needs to reachconsensus on:

 – The starting point of the

process.

 – The ending point of theprocess.

• Write beginning and ending step

on two Post-It note and put on a

sheet of flip chart paper. Outpu t =Consensus reached

on beginning and

ending step of the

process being

documented.

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Step 3: Develop the Process Map

• The team is now ready to fill in “the

blanks” between the beginning and

ending steps in the process.

• The team will use additional Post-It

notes to write down, in order, the

steps between the beginning andend of the process.

• This creates the Process map which

shows the general, not the detailed,

steps in the process.• The steps of the Process Map are

the Standard Operating Procedures

(SOPs) for the process.

Output = Aprocess map

showing the SOPs

for the process  

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Step 4: Do we Have Agreement?

• Does everyone agree with

the Process Map?

 – If everyone agrees proceed

to step number 6.

 – If everyone is not in

agreement, proceed to stepnumber 5.

Output = A Decis ion as to

whether al l team members

are in agreement with thecreated Process map.

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Step 5: Con t inue Discuss ion un t i l

Everyone Ag rees

• The standard operating procedures will describehow the process will be operated in the future.

• It is essential that everyone agrees on the steps

and the order in which they are in.

• Discussion must continue until consensus decisionis reached by the team on all the steps in the

process.

Outpu t = Ag reement on the standard operat ing pro ceduresfor the process .

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Step 6: Number the Steps in the Process

Map

• The boxes/each Post-It note, in the Process Map

needs to be numbered as sequentially as possible.

• The first box could be labeled as x.1, because it is aprocedure.

• The “x” is the number based on your control

document format.

• When preparing for ISO-9000 registration, allprocedures could have the number x first, then a

decimal point and then the sequential numbers of

the boxes of the process map (x.1, x.2, x.3, etc.).

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Step 6: Number the Steps in the Process

Map

• Once the boxes of the process map are numbered,

arrows should be drawn to connect the boxes.• Ensure that each decision point has both a “yes” and

a “no” path. 

• The process map may or may not be part of your

documentation.• You may elect just to write out the steps as standardoperating procedures.

O utput = A p rocess map for the process w i th each of the

steps num bered sequent ial ly and with arrows drawn. 

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Step 7: Write the JWI’s 

• For each step in the

process map, write the

detailed instructions for how

the step is done.

• Beginning with the first step

of the process map, theteam writes down exactly

how the step is done.

• These are the job work

instructions (JWIs) for thestep.

• The JWIs are numbered

based on the number of the

steps in the Process map.

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Step 7: Write the JWI’s 

• For example, the first JWI for the first step in the

Process Map could be numbered x.1.1.

• The second JWI for the first step could then be

numbered x.1.2, etc.

• JWIs need to be developed for every step in the

Process Map.

Outpu t = Job Wo rk Instruc t ions (JWIs) developed for each

step of the process map for the process.

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Step 8: Does Everyone Agree?

• Does everyone agree with the job work instructions?

•  As with the Process Map, it is essential that the teamreach consensus on the job work instructions foreach step.

• If the team agrees, proceed to step 10.

• If there is disagreement, proceed to step 9.

Out Put = A decis ion as to w hether al l team members are in

agreement with the created job work ins truct io ns.

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Step 9: Cont inue Discussion un t i l Everyone

Agrees

• Job work instructions will

describe how the process

will operate in the future.

• It is essential that everyone

agrees on this step.

• Discussion must continue

until a consensus decision

is reached by all team

members on all JWIs.

Output = Ag reement on the

 job work ins truc t ions fo r each

step of the process.

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Step 10: Obvious Areas for Process

Improvement?

•  Are there obvious areas where

the process can be improved?• Remember we are only looking

for obvious areas for

improvement, overall process

improvement is not addressedwith this model.

• The team steps back and look

over each step of the process.

• If there are obvious areaswhere the process can be

improved, proceed to step 11.

• If there are not, proceed to step

12.

Out put = A

decis ion as to

wh ether th ereare obvious

areas where the

process can be

improved.

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Step 11: Make Changes to the Procedure

• The obvious areas for improvements needs to be

discussed and they should be reflected in

 – Corrected standard operating procedure

 – Corrected job work instructions

•  When SOPs and JWIs have been revised they will

reflect the obvious areas for process improvement.

Output = Obvious process improvements made: SOPs and

JWIs revised to ref lect proc ess changes made .

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Step 12: Write the SOPs and JWIs using the

Contro l led Document Format

• If your organization is involved in ISO-9000 and has a

standard format to document SOPs and JWIs, these following

9 steps should be defined.1. Recipients: Specifies the distribution of the documents.

2. Purpose: Explains what purpose or objective the document is

supposed to accomplish.

3. Process Success Indicators: Shows Performance Metrics in

line with objectives

4. Scope: Indicates what segments of the organization or its

operations are affected by this document.

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Step 12: Write the SOPs and JWIs using the

Contro l led Document Format

4. Responsibility: Defines who is responsible forimplementation of this procedure.

5. Definitions: Explains words, terms, or abbreviations

not commonly known by any of the intended users of

the document.6. Procedure: Provides guidance on what actions are

required to accomplish the purpose of the document.

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Step 12: Write the SOPs and JWIs using the

Contro l led Document Format

7. References: Lists information that identifies other

documents that are mentioned in the contents ofthis document as Reference ().

8. Records/Attachments: Lists attachments and

necessary records to show status of processactivities/performance in line with objectives

9. Signature: Signature of approving official or theadministratively authorized delegate.

Outpu t: Final con trol docum ent form at detai l ing the SOPs

and JWIs for the process .

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Example - Controlled Document Format for SOPs & JWIs

1.0 Purpose

The purpose of this document is to provide procedures for writing standard operating procedures and job work instructions as required under Quality System Policy xx (Reference 1). In general, astandard operating procedure refers to the steps in a process map depicting the process. The jobwork instructions, which accompany the standard operating procedure, are the detailed instructions

for completing each step in the process map.PSI: Number of out of control variations in process output due to procedure

2.0 Scope

This procedure applies to all company associates who write standard operating procedures and jobwork instructions. 

3.0 Responsibility 

 All associates have the responsibility to write standard operating procedures and job workinstructions as defined in this document. 

4.0 Recipients  All SOP/JWI Manuals. 

5.0 Definitions 

PFD: Process map

SOP: Standard Operating Procedure

JWI: Job Work Instruction 

6.0 Procedure 

The process map for this procedure is shown on the next page. The JWIs follow the PFD.

Company Name SOP/JWI

Manual Section: Prepared By:

William H. McNeese 

Control Copy _______Subject: Standard Operating

Procedure/Job Work Instructionxxxx Writing Standard OperatingProcedures and Job WorkInstructions

Effective

Date:

Revision:

Initial Issue 

Page: x of 6

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Example - Controlled Document Format for SOPs & JWIs

Process map for Developing Standard Operating Procedures and Job Work Instructions 

Meet withthose closestto the process 

Determine the

starting andending pointsof the process 

Develop the macro

 process map  by sketching out thesteps in the process 

Does everyoneagree with theProcess map? 

 Number thesteps in the

 process map

Write the standardoperating procedure and

 job work instructions forthe process using thecontrolled document

format 

Continuediscussion

until everyoneagrees 

Yes 

 No 

6.1  6.2  6.3 

6.4 

6.5 

6.6  6.7 

For each step in the process map

write the detailedinstructions forhow the step is done

(job work instructions) 

Does everyoneagree with the job

workinstructions? 

Continuediscussion

until everyoneagrees 

Are thereobvious areas

where the process can be

improved? 

Make thechanges to the

 procedure 

 No 

Yes 

6.8 

6.9 6.10 6.12 

6.11 

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Example - Controlled Document Format for SOPs & JWIs

6.1 Meet with those closest to the process.

6.1.1 Select several associates who are closest to the process (i.e., involved in

actually performing the work) being documented by the standard operatingprocedure and job work instructions. Selected associates should be "best ofclass" (those who perform the best in the process).

6.1.2 Arrange a meeting time that will be convenient for the associates and thatwill have no interruptions.

6.1.3 Ensure that flip chart paper, pens, and post-it notes are available for themeeting. 

6.2 Define the beginning and ending steps of the process. 

6.2.1 Reach consensus on the beginning and ending steps of the process you aredocumenting. The beginning step will be the first block on the process map. Theending step will be the last block on the process map. 

6.3 Develop the macro process map by sketching out the steps in the process. 

6.3.1 Write down the first step and last step on post-it notes and place them on flipchart paper.

6.3.2 Using the post-it notes, write down each step in the process between the firstand last steps. A process map shows the general, not detailed, steps in a process(Reference 2). For example, a step in a process map may be "Enter the order into

the computer." The job work instructions to be written later will contain the detailsof how to "Enter the order into the computer."

6.3.3 The steps in the process map correspond to the SOP for the process. 

6.4 Does everyone agree with the steps in the process map? If yes, go to step6.6. If no, go to step 6.5. 

6.4.1 If there is disagreement on the steps in the process, go to step 6.5. Ifeveryone agrees, go to step 6.6

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Example - Controlled Document Format for SOPs & JWIs

6.5 Continue discussion until everyone agrees.

6.5.1 Since the standard operating procedures will describe how the process is to

be operated in the future, it is critical that everyone agree on the steps. Work mustcontinue until everyone reaches consensus on the steps in the process.

6.6 Number the boxes in the process map.

6.6.1 Number each box in the PFD beginning with step 6.1. Be sure that all boxesare numbered sequentially if possible.

6.6.2 All steps in the standard operating procedure are numbered as 6.x.

6.6.3 Draw in the arrows on the process map.

6.7 For each step in the process map, write the detailed instructions for how the

step is done (job work instructions).6.7.1 Beginning with the first step in the process map, write down exactly howeach step is done. These are the job work instructions for the first step. Completethis for each step in the process map.

6.7.2 The job work instructions are numbered based on the number of the step inthe process map. For example, the first job work instruction for the first step in theprocess map is numbered as 6.1.1, the second job work instruction for the firststep is numbered 6.1.2., etc.

6.8 Does everyone agree with the job work instructions? If yes, go to step 6.10. If

no, go to step 6.9.6.8.1If there is disagreement on the job work instructions, go to step 6.9. Ifeveryone agrees, go to step 6.10

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Example - Controlled Document Format for SOPs & JWIs

6.9 Continue to work on the PFD until everyone agrees. 

6.9.1 Since the job work instructions will describe how the process is to be

operated in the future, it is critical that everyone agree on the steps. Work mustcontinue until everyone reaches consensus on the job work instructions. 

6.10 Are there obvious areas where the process can be improved? If yes, go to step6.11. If no, go to step 6.12

6.10.1 If there are obvious areas where the process can be improved, go to step6.11. If there are not, go to step 6.12.

6.11 Make the changes to the procedure.

6.11.1 If there are obvious areas where the process can be improved, the

standard operating and procedures should be changed to reflect theseimprovements.

6.12 Write the standard operating procedure and job work instructions using thecontrolled document format.

6.12.1 Use the controlled document format shown in attachment A.

6.12.2 Write a brief explanation what purpose or objective the document issuppose to accomplish (1.0 Purpose in attachment A).

6.12.3 Determine and write what segments of the company or its operations areaffected by this document (2.0 Scope in attachment A).

6.12.4 Write the instructions for who is responsible for the procedure (3.0Responsibility in attachment A).

6.12.5 Specify what SOP/JWI manuals are to receive this document (4.0Recipients in attachment A).

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Example - Controlled Document Format for SOPs & JWIs

6.12.6 Write the definitions of any words, terms, or abbreviations not commonly known byany of the intended users of this document. (5.0 Definitions in attachment A).

6.12.7 Write the standard operating procedure as depicted in the PFD (6.0 Procedure inattachment A). These steps will be in boldface type on the controlled document.

6.12.8 Write the job work instructions that were developed for each step of the SOP.These will be in plain type face on the controlled document.

6.12.9 Make a list of any references mentioned in the document (7.0 References inattachment A). A reference should be made to the Quality System Policy that requiresthe development of this document.

6.12.10 Make a list of any records/attachments to the document (8.0Records/Attachments in attachment A). The process map should be an attachment.

6.12.11 Write down the title of the person who will approve the document and leave aplace for his/her signature. 

7.0 References 

(1) Quality System Policy xx 

8.0 Records 

Minutes of Process mapping/ review sessions, records of causes of processvariation due inarticulate procedures.

9.0 Signature 

 Approved: ____________________________

Title: ________________________________

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S i b tt28

Summary

• SOPs/JWIs are used to document the steps in a

process.

• SOPs/JWIs help standardize the way the process is

operated and help reduce variations.

• SOPs/JWIs are developed by “best of class.”