GLOBAL PRODUCTS MANUFACTURING OPERATIONS

Behavior Based Quality

Observer training
March 2017

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INTRODUCTION

What is Behavior Based Quality?

• BBQ is a peer-to-peer observation process that identifies both

positive and negative quality behaviors. The observation is
performed by a trained employee who will identify the location,
but not the name of the employee observed. If the observer sees
an at-risk behavior, it is addressed on the spot by the observer.

• BBQ fosters individual accountability by rewarding correct

essential quality behaviors and eliminating targeted at-risk
behaviors in an effort to reduce deviations, data integrity and
documentation practice issues.

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WHY BBQ

Fact: We have received observations from AQR and Agencies on

basic Compliance

• Not following procedure

• Poor documentation and labeling
• Unapproved documents in use

Impact:
• Loss of customers (patients and Agency) trust regarding
assurance of the quality, safety and efficacy of the products we
manufacture
• Damage to Abbott Brand reputation

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ROLES AND RESPONSIBILITIES

Role Responsibilities
BBQ  Maintain the BBQ schedule and process
 Review and analyze BBQ data.
Coordinators
 Define the necessary actions based on observation
 Communicate metrics of the program to all employees

BBQ  Attend training.

 Perform observations rounds and give feedback on observed positive and at risk
Observers behavior .
 Discuss the results of each BBQ round with to the responsible coordinator

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TODAY’S SESSION

Our objectives:
• Explain the importance of quality in the workplace
• Explain Behavior Based Quality
• Identify Behavior Based Quality requirements and processes
• Apply the individual steps required to implement Behavior Based Quality in
the workplace

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ABBOTT’S COMMITMENT

• BBQ fosters individual accountability by

rewarding correct essential quality behaviors
and eliminating targeted at-risk behaviors in
an effort to reduce deviations, data integrity
and documentation practice issues.

• “No Name, No Blame”

• Open communication is critical

UNDERSTANDING HUMAN BEHAVIOR

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OBSERVATION

If at-risk
Record the behaviors If at-risk
Review the Select area observed, behaviors are
observed Recognize quality
current to observe give observed
safe and at behaviors
targeted constructive record reasons
risk
behaviors feedback on the card
behaviors
4
1 2
3 5 6
OBSERVATION STEPS

Review the
current
targeted
behaviors

1
OBSERVATION CARD
OBSERVATION CARD
DOCUMENTATION
Documentation
1. Write with indelible, waterproof ink
2. Errors are corrected properly
3. Information recorded what really occurred
4. Information is readable
5. Information is recorded immediately after the action was performed
6. Person recording the information is the one who did the work
7. Easy to understand what the information means
8. When making comments it must be clear as to what step or error the
comment refers to
9. Abbreviations or codes only if well defined
10. Use of approved formatting and identification (data, eg equipment)
OBSERVATION CARD
DOCUMENTATION
Documentation
11. Information must by entered directly in the relevant record
12. Blank spaces are appropriately handled
13. Additional documents are referenced appropriately and included if
necessary
14. Do not use sticky notes, scratch paper, or any other unofficial document
15. All records should be retrievable and nothing is discarded
16. Documents are maintained and stored by assigned personnel in an
appropriate area
 OBSERVATION CARD
GOOD HOUSEKEEPING
Good housekeeping
1. How do you know that an area is approved for use? How do you know the
status?
2. Which tasks do you perform for (in) good house keeping? How do you know this
is correct and complete?
3. How are you involved in the current status of equipment?
4. Do you know which cleaning agents you need to use? Where to get them how to
store them?
5. What do you think of the current status of this area? How did you check it
before performing activities? Do you know what to look for (to check) and do you
know how to report any defects? Do you know when a defect is identified if you
still can continue your activity?
 OBSERVATION CARD
GOOD HOUSEKEEPING
Good housekeeping
6. Are all the necessary tools/ equipment for your activity available?
7. Explain the use of all the equipment tools in this area?
8. How do you check the status of equipment? How did you check it before
performing activities?
OBSERVATION CARD
ADHERENCE TO PROCEDURE

Adherence to procedure
1. Is the sequence of the procedure/instruction correctly followed
2. Is the valid and correct procedure used? How do you know you have the
correct version?
3. Can the operators confirm which procedure is followed and how do you
access the procedure?
4. How do you know that you are trained on these procedure?
5. How do you know what to be trained on? When to have retrain?
6. How do you know you are using a controlled document/instruction?
7. Which process do you follow for addressing adjustment to procedure. How
are you involved in that process?
OBSERVATION STEPS

Select area
to observe

• Plan the time and place of your

observation
• Not always same area
• Not always same process step
• Not always same time of the
day
OBSERVATION STEPS

Record the
observed safe
and at risk
behaviors

Potential challenge:
• Not become bucket full of good ideas
• Not exceed observation round of longer than 20 minutes
OBSERVATION STEPS
• Acknowledging and recognizing positive quality behavior is
Recognize essential to achieve sustainable quality excellence.
quality
behaviors

4
IMPORTANCE OF SOLID RECOGNITION
• Positive reinforcement of the essential quality behavior
Recognize elevates a quality culture.
quality
behaviors • Continual reinforcement of favorable behavior helps
achieve a high level of quality awareness and performance.
• Recognition should be TIMELY, RELEVANT and
4
SINCERE
OBSERVATION STEPS
Giving feedback means expressing direct concern about
Give another person’s at risk quality behavior
constructive
feedback

5
Why should you give feedback?
• Speaking up may prevent deviations, data integrity
and documentation practice issues
• Elimination of rework, it also leads to better quality
product for our customer and an increase in our brand
equity as regulators and our customers see us in a
more favorable light.

Employees may assume their actions are

acceptable is nobody tells them otherwise
HOW TO GIVE FEEDBACK

Give

Commit
constructive
feedback
• Find out why they
5 are doing what they
are doing • Work together to find
• Ask if you can discuss the compliant way
your concerns • Get a commitment
from them

Ask
OBSERVATION STEPS
If at-risk
behaviors are
observed
record
reasons on
the card

6
OBSERVATION STEPS

If at-risk
behaviors are Code 1: Procedure/Training
observed
record • Not knowing or forgotten the procedure
reasons on
the card • Not trained on the procedure
6
• Not trained on how to perform the job
• Ambiguous or incomplete procedure
• Trained on how to perform the procedure but
in incorrect manner
• Too long since last training
• Unqualified
OBSERVATION STEPS

If at-risk
behaviors are Code 2: Organizational Factor
observed
record • Management Pressure to finish the job quickly
reasons on
the card • Main emphasis on time and units not on
6
Quality
• Peer pressure, going along with the crowd
• Everyone does/does not do it that way
• Poor job coordination
• Recognition system in place to encourage
quality behaviors
OBSERVATION STEPS
If at-risk
behaviors are
observed
Code 3: Facility/Equipment
record
reasons on • Equipment or facility design encourages the
the card behavior
6 • Environment related
• Equipment/Tools not available
• Area/Equipment/Tools in bad condition
OBSERVATION STEPS

If at-risk
behaviors are
observed
Code 4: Personal Factors
record
reasons on
• Not thinking, mind not on the task at hand,
the card preoccupied, self-imposed pressure, sickness.
6
• Routine task creating repetitive motion or low
mental stimulus – daydreaming.
• Employee not positively motivated.
• Employee attitude positive, but predisposed to
rushing tasks.
OBSERVATION STEPS

If at-risk
behaviors are
observed
Code 4: Personal Factors
record
reasons on
• Employee attitude positive, but predisposed to
the card rushing tasks
6
• Young or inexperienced employee – lack of
experience or perception of hazards.
• Employee preoccupied
• Self imposed pressure
COMPLETE YOUR OBSERVATION
• Return your observation form to the BBQ
If at-risk
behaviors are Coordinator
observed • Discuss the observations with him/her
record
reasons on
the card
6
INTERVIEWING SKILLS

Established Pharmaceuticals Division

WELCOME

This workshop is intended to highlight

various techniques and
communications styles to enhance
BBQ Observer communication, such
as:

 Interview Techniques

 Body Language (Verbal and Non-Verbal)

 Role Playing Exercise

INTERVIEWING TECHNIQUES

 Friendly

 Probing

 Restate Some Questions

 Long Pause / Silence

 Open Ended Questions

 How do you…?
 Why is this….?
 What is the….?

 “Help me understand”….

 Compare answers to records and

procedures

 Observe body language (Verbal & Non-

Verbal)
BODY LANGUAGE (VERBAL AND NON-VERBAL)

VERBAL:

 Failure to answer a question

 Delayed answer

 Selective memory

 Inconsistent answers

 Incomplete sentences
BODY LANGUAGE (VERBAL AND NON-VERBAL)

NON-VERBAL:

 Behaviours:

 Overly nervous

 Evasive

 Defensive

 Quiet
a) H
b) H
BODY LANGUAGE (VERBAL AND NON-VERBAL)

NON-VERBAL:

 Posture:

 Slouching

 Very Rigid

 Erratic and rapid

changes in posture

 Lack of eye contact

a) H
b) H

WHAT WILL YOU DO TO MAKE

A DIFFERENCE?
INTERVIEWING SCENARIOS

Directions

 As you observe the following scenario, answer the following questions on

the provided worksheets:

1. What technique did the observer use?

2. What do you think the observer was looking for in the interview?

3. What interviewing techniques were effective (not effective)?

4. How did the interviewee respond?

5. What other interviewing technique(s) could have been used to

potentially obtain the information the observer is seeking?
Questions?

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THE KEY TO SUCCESS IS YOUR UNDERSTANDING

OF WHAT IS EXPECTED OF YOU

Be compliant
protect our brand
everyone’s responsibility

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SUMMARY: THE BBQ CYCLE

Conduct
Communicate
Observation
Data

Recognize
and
Acknowledge Provide
Participation Feedback

Submit
Observation
Data
YOUR ROLE IN MAKING BBQ A SUCCESS

• Practice

• Walk the Talk

• Speak up

• Own it!

You are the final piece of a truly Quality environment!

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CALL TO ACTION

• Learn and know the specific behaviors per topic

• Learn and know local Good Documentation

Practice procedure

• Be able to explain the BBQ program and the

reason for BBQ to the interviewee (not an
internal audit)

• Start BBQ round in April beginning topic is

“documentation”

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