making policies and procedures work—applying key concepts of

Making Policies and Procedures Work—Applying Key Concepts of Critical Thinking

Karl P. Keller

Phone: 847-424-0608Fax: 847-328-5536Email: [email protected]: www.communipartners.com

Sponsored by

Tim GuntherDirector of Business [email protected] x 6033

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Agenda – What we want to cover today

• About Communication Partners

• Why policies and procedures?

• Critical Thinking Part 1: The Conceptual

• Critical Thinking Part 2: Categorizing

• Critical Thinking Part 3: Organizing and Creating Content

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At Communication Partners, we specialize in helping businesses communicate profitably – communipartners.com

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Why sets Communication Partners apart? Our experience with complex content

Principals teach at Northwestern, including Engineering, Business and Medical schools; teach in the professional masters program in Quality and Regulatory Sciences (QARS); we’ve been thought leaders in integrating communication into the technical curriculum

Communication Partners has long experience improving complex business and technical communication in consumer, media, pharma, engineering, technology, and consulting firms

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Before we dive into the agenda, let’s step back and look at the big picture

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Businesses of all kinds either have or need policies and procedures

Driven by regulations, and/or best practices, and/or corporate standards

However, for many organizations, policies and procedures are in a state of flux

Usefulness may be impaired for many reasons: • inconsistent structure and format• internal non-experts doing the writing• organizational confusion about what should,

in fact, be documented

The Key Question How, then, to bring order, coherence - and above all USEFULNESS - to policies and procedures?

The SolutionApply key concepts of critical thinking to the development and delivery of policies and procedures

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Why do organizations have policies and procedures?

• Comply with regulations• Comply with best practices• Comply with company commitments• Keep job performance uniform• Keep activities uniform• Eliminate surprises• Cut liabilities—safety, personnel, legal• Serve as a reference or guide• Train new employees• Enhance security• Measure results, performance • Convey the culture of the business

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• Critical Thinking Part 1: The Conceptual – Understanding difference between processes, policies, and procedures – Using precise language



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Understanding key terms is a critical thinking concept you must master before drafting effective policies and procedures

Term Definition Function

By understanding the process, you know the outcome and keep the “end” in mind

A set of logically related tasks performed to achieve a defined outcome (can contain multiple policies, procedures)

• Manufacturing drugs• Running research lab• Delivering auditsProcess

Policy

A set of requirements, what must be done, prompted by sound business, safety, legal, ethical, regulatory demands

By defining policies, everyone knows what must be done

• Must follow CFR Rules• Must properly store reagents• Must have annual audits

ProcedureA series of steps to follow to execute a business process or implement a policy

By documenting procedures, those who execute them know exactly what they must do, and in what order

• To follow CFR Rule #, do…• To properly store reagents,

do..• To execute annual audits,

identify…

Example

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Another critical thinking task: know organizational outcome[s] you want, then map processes, policies, and procedures

Providing Quality Laboratory Tests

Policies(when executing process)

You must log all samples received

All tests must use sufficient

sample amounts to ensure tests

are accurate

You must store samples in approved containers

Achieving this outcome

Procedure (s)(to implement policy)

Involves many Processes

(to achieve outcome)

To test sample A:Step 1Step 2Step 3Step N






are accurate



Taking in Samples Testing Samples

11Poll Question 1

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• Critical Thinking Part 1: The Conceptual – Understanding difference between processes, policies, and procedures– Using precise language



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Processes, policies, procedures have their specific language patterns

Providing Quality Laboratory Tests

Policies(commitment when executing process)You must log all

samples received



are accurate


Taking in Samples Testing Samples

Procedure (s)(methods to implement

policy)

Processes(to achieve outcome)

To test sample A:Step 1DoStep 2Step 3Step N

--ing word…

Must…

Impose the language pattern!!!

Imperative…

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Outcome

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It’s hard to determine which example belongs to what category if language is not precise

Process

Policy

Procedure

Taking in samples for laboratory tests

Store samples in approved containers

Conduct a quality control audit

Replace a spectrometer

Replace a spectrometer after 3 years

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These examples are not precise

ProcessMust store samples in approved containers

Conducting a quality control audit

To replace a spectrometer

Must replace a spectrometer after 3 years

Now the examples are precise

This first example is precise

Poll Question 2

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• Critical Thinking Part 2: Categorizing – Taking an “undifferentiated” mass of words, and “chunking” them into

appropriate categories and component parts


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Understanding components of document hierarchy can help you draft effective policies/procedures

Required Definition Function

Policy Requirements What must be done, prompted by sound business, safety, legal, regulatory demands

By defining policies, everyone knows what must be done

Purpose The reason for a specific policy and the procedures to implement the policy

By establishing purpose, everyone knows why policy must be followed

Procedure A series of steps to follow to achieve the policy

By documenting procedures, those who execute them know exactly what they must do, and in what order

Roles & Responsibilities Actors in the policy and procedure and what they are accountable for

By defining roles and responsibilities, everyone knows who must do what and when

Definitions Items and concepts employed in the policy and procedure, or the procedure itself

By establishing definitions, terms and concepts are clear

As needed

Scope/Areas Affected Specific processes and areas policy applies to

By defining scope, everyone knows where policy applies and by inference where it doesn’t

Reasons for Revision Why policy/procedure has changedBy pinpointing revisions, everyone knows why changes have occurred

Materials required Essential items to execute policy / procedureBy pinpointing materials required, everyone knows what they must have to execute policy/procedure

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Note that in some organizations, policies and procedures are placed in separate documents

Policies

Policy 2 Policy 3. . .Policy 1 . . .Policy N

Procedures

ProcedureB

ProcedureC. . .

Procedure A

. . .ProcedureZ

Placing policies and procedures into separate documents has two “document management” advantages:

1. Allows easy reference via table of contents and/or index for numerous policies

2. Requires only one procedure document – a procedure may apply to multiple policies

Note: Policies may not necessarily have procedures required

Note: Procedures may not necessarily be associated with a policy

PolicyOverview

PurposesScope

RequirementsRoles and ResponsibilitiesReason for RevisionsApproverContact Person

ProcedureOverview

PurposesScopeRequirements

Procedure1…2…3…

Roles and ResponsibilitiesReason for RevisionsApproverContact Person

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You can of course combine policies and procedures into one document

PolicyOverview




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But if you do, you MUST (a) separate policies from procedures so readers are clear about where they are in the document and (b) consistently apply the distinct language patterns.

Policies

Policy 2 Policy 3. . .Policy 1 . . .Policy N

Procedures

ProcedureB

ProcedureC. . .

Procedure A

. . .ProcedureZ

Note: Policies may not necessarily have procedures required

Note: Procedures may not necessarily be associated with a policy

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As mentioned in the previous slide, we see organizations who fail to demarcate policy items and procedure items

PolicyOverview




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Organizations that produce stand-alone SOPs (Standard Operating Procedures) or “Work Instructions” are especially prone to this problem

Right way

Work InstructionsRequirements

Some Policy content mixed in with some Procedure content

InstructionsSome Policy content mixed in with some Procedure content

Wrong way

Poll Question 3

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• Critical Thinking Part 3: Organizing and Creating Content– Using principles of “structured writing” to organize your “chunked”

material for easy reading and quick reference– Using effective writing techniques: Writing Tips– Using flow charts to capture and document procedures

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Structured writing differs from traditional writing in two key ways

1. More modules Traditional Units Structured Units

Sections Sections

Paragraphs TopicsSubtopics

Sentences Sentences

Headings are either numbered and/or in a column on the left.

2. Different layout

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Requirements are grouped together into subtopics

Structure of document – consists of topics and subtopics that you must organize logically

Hand Washing within Biohazard Lab

Purpose Definitions Policy Requirements

Must wash with anti-bacterial soap

Must wash in following circumstances

Procedure

Before entering lab

Before executing any tests

After handling materials, equip Before exiting lab

Subtopics

Specific requirements come from regulations, safety needs, best business practices

Title

Sub-subtopics

Topics

Your mantra: categorize and chunk!

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Note: topics and their lower levels must be MECE

Mutually Exclusive Collectively Exhaustive* *Source: McKinsey & Co.

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One template format: combined Policy and Procedure comprises 4 topics

Topic Subtopics1. Overview Policy Title (name and numbering)

PurposeDefinitionsScopeAreas Affected

2. Requirements Phrased as a “must” if required; “may” if optional

3. Procedure Steps; phrased with the imperative; designate the actor if a specific actor has to perform it

4. Appendix Roles and ResponsibilitiesReasons for RevisionsApproverContact Person

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Here is Communication Partners’ policy template

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Topics Highlighted

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Subtopics signaled

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Process language applied consistently

Policy language applied consistently

References aligned

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material for easy reading and quick reference– Using effective writing techniques: writing tips– Using flow charts to capture and document procedures

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Tip 1: When listing policy requirements, use the correct verb form: must, is required, or may.

Use the terms “must” or “is required” to indicate that something is a requirement: “

The supplier selection process must include the following.

Laboratory personnel are required to were latex gloves when opening vials.

• Must

• Is required

Use the word “may” to indicate that a requirement is conditional:

The supplier may provide a sample of the purchased material for testing before shipment.

When purchased materials cost more than $5000 per pound, the manufacturer may supply a notarized certificate as evidence that this material conforms to established specifications.

Each requirement must use one of these verbs.

Tip: Avoid using the verbs “will,” “should,” or “can.” These create ambiguity.

• May

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Tip 2: To make lists more concise, put the “must,” “is required” or “may” in an introductory statement

• For exampleLaboratory personnel receiving shipments must do the following:– Confirm that the purchased material was received from an approved supplier– Match the quantity received with the bill of lading and initial the bill of lading– Enter information about the shipment into the company’s computer system. – Store all containers in the supply room with label face out

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Tip 3: In writing lists or tables, use active voice

A sentence written in active voice indicates “who” is doing “what.” By contrast, a sentence in passive voice indicates “what is being done.”

Correct (active) Incorrect (passive)

Follow the steps in the table to revise the reevaluation period.

The steps in the table should be followed to revise the reevaluation period.

The quality control unit must approve the expiration date.

The expiration date must be approved by the quality control unit.

Active voice can either be in “command form” or “subject-verb” form.

command form

subject-verb form

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Tip 4: For bullet lists, use parallel construction

Examples of information that may be used to determine the expiration period are listed below.

– vendor stability data that indicates expiration of the material

– in-house stability data that indicates expiration of the material

Examples of information that may be used to determine the expiration period are listed below.

– vendor stability data that indicates expiration of the material

– review in-house stability data that indicates expiration of the material

In a parallel list, every item is the same kind of grammatical structure: noun phrase, verb phrase, full sentence, etc.

Parallel list:

items are noun phrases

Non-parallel list:

one item is a noun phrase, the other is a command

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Tip 5: Aim for consistency in writing

• Hands must be washed with the following materials:

• Hand must be dried with the following materials:

• Hand washing must be executed with the following materials

• Hand drying will require the following materials listed below:

By phrasing similar things in similar ways, you will set up a pattern that makes it easier for readers to understand and remember.

Correct (similar phrasing) Incorrect (different phrasing)

Phrase similar things in similar ways—even when items are in different subtopics.

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v

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Tip 6: Write concisely. Shorten phrases, eliminate words that are not necessary for meaning.

Vigilance is necessary to ensure that received materials are handled consistently in the loading process, in accordance with Six Sigma values.

A high level of vigilance is necessary to ensure that received materials will be handled in a consistent mannerthroughout the unloading process thus contributing to the maintenance of company’s Six Sigma values

Extra words get in the way of easy comprehension.

More conciseWordy

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Tip 7: For multiple step procedures, use tables

• Step action tableActions are best expressed in a step/action table

Step Action1 Put the step number in the left

column

2 Put the action in the right column

Conditional actions are best expressed in an if/then table; actions typically mutual exclusive

For DoA Y

B Z

• If/then table

• Decision table

If ThenA is true You do B

C is true You do D

Actions based on similar categories are best expressed in decision table; actions typically non-exclusive and can be cumulative

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Tip 8: Procedures may also require “helpers”: information that supports steps in a procedure

The table below describes when to use common helpers

Helper When to use

Note Use a note to add general information the reader needs to know to complete steps. A note contains no action statements

Result Use a result to point out something observable that occurs when an action is completed correctly

Example Use an example when it would help clarify the information in a step

Warning, Caution, or Danger

Use a warning, caution, or danger to point out a possible danger or cost of improperly performing a step

Reference Use a reference if the reader needs to go to another part of the document or another document

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material for easy reading and quick reference– Using effective writing techniques: Writing Tips– Using flow charts to capture and document procedures

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Flow diagrams are useful to illustrate the procedure for executing a policy or process

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Note: it is very useful when documenting a procedure to have many individuals produce a flow diagram. Doing so uncovers different perspectives, different assumptions, and different ideas about what some consider essential to include in the “flow” and what some consider non-essential.

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User

Customer Care Agent

Relationship Data System

Problem Diagnosis System

Service System

ServiceAgent

Place Call

Identify User

Get User data

Known? Yes

No

Provide Personal

Data

Enter Data

Update Data

Ask about

problem

Provide problem details

Consult problem/service systems

Fixable by

user?

Yes

No

Enter Service Request

Get Procedure

Explain Procedure

Go to User

House

Solve Problem

ArrangeAppt

End Call

Swimlane diagram: shows how procedures are allocated to stakeholders (people and systems)

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Summary: What key “critical thinking” ideas did we cover today?

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Difference between processes, policies, and procedures

The advantages of structured writing—i.e., topics and subtopics, along with tables–-and ways to write sentences and lists

The appropriate categories – Purpose, Policy Requirements – etc. of a well-thought out document

The usefulness of flow charts to document procedures—and to bring consensus about what is important in the procedure

But, alas, what we’ve covered is conceptual—what really counts is in the execution of creating/revising your policies and their accompanying procedures according to this framework.

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To help you think through execution, Communication Partners is please to make the following offer:

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For the first 10 Webinar participants who e-mail [email protected]

. . .we will provide a no-charge 30-minute consultation.

Our Next Webinar will be Tuesday, 9/18 at 1:30 EST,

Five Essential Components of an Effective Policy & Procedure ProgramPresented by Raymond ErgoInvites to be emailed shortly

Tim Gunther, Director of Business Development, [email protected]

Thank you again for participatingSponsored by

making policies and procedures work—applying key concepts of

Documents