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CONTROLLING Part Two Nelia B. Perez RN, MSN College of Nursing  Northeastern College Santiago City 3311
Establishment of Objectives and Methods for Measuring Performance Task analysis -  actions and procedures are inspected -  written guides, schedules, rules, records, and budgets. -  uses tools as time studies and checklist Quality Control -  Activities and techniques employed to achieve and maintain the quality of a product, service or process. -  includes a monitoring activity of but is also concerned with finding and eliminating causes of problems so that the requirements of the customer are continually met.
Measuring actual Performance An ongoing, repetitive process with the actual frequency dependent on the type of activity being measured.
PERFORMANCE MATCHES STANDARDS & OBJECTIVES PERFORMANCE IS CONTRARY TO STANDARDS & OBJECTIVES SET
RESPONSIBILITY OF HEAD / SENIOR NURSE
The Dreaded Performance Appraisal
I’m always ready to learn, although I do not always like being taught. Winston Churchill
Conducting A Performance Review
What Do Managers Like Least? •  Firing an employee •  Performance appraisals
Managers take a big share of the credit for success. We also have to take the blame for failures – including those of our staff.
You play a major role with those you supervise. Your staff wants to know your opinion of their work. Talk to them regularly as part of your ongoing coaching.
SETTING STANDARDS
Setting Standards • Everyone doing a job should know what he/she is expected to do. • Standards must be attainable. • There must be a point against which performance can be measured.
Setting Standards • Involve your staff in setting standards. • Self-evaluation will then become automatic. • Corrective action can be taken immediately. • You provide the encouragement to stay on target.
ACTION STEPS
Action Steps Working with Human Resources: • Review your department’s job descriptions. • If needed, add a list of standards to be met. • Design an evaluation system – how will you measure performance?
There’s More! Part 2: Structuring the performance review • Review and preparation • Putting the employee (and you!) at ease • Giving feedback
There’s More! Part 3: Giving negative feedback & setting goals • Structure for giving negative feedback • Reviewing last year’s goals/setting new goals • Career development plans • What NOT to do • Ending on a positive note
PERFORMANCE APPRAISAL
PURPOSE COMPENSATION CAREER PLANNING FEEDBACK TRAINING HUMAN RESOURCE PLANNING EXIT RESEARCH MOTIVATION IS THE OVERALL PURPOSE
WHAT IS APPRAISED? INDIVIDUAL TASK OUTCOMES BEHAVIOUR TRAITS COLLECTIVE OUTCOMES COLLECTIVE PROCESSES WHAT IS EXPECTED OF THE PERSON?
WHO APPRAISES? IMMEDIATE SUPERIOR HIGHER LEVELS PEERS SELF IMMEDIATE SUBORDINATES COMMITTEE
METHODS OF APPRAISAL WRITTEN ESSAYS (ACR) Final appraisals are frequently in a written narrative form  Supervisor rates employee’s: Performance factor or skill Give examples & an improvement plan Explains good & bad performance areas Subjective CRITICAL INCIDENTS
GRAPHICAL RATING SCALES Define the Traits Potential Appraisal
BEHAVIOURALLY ANCHORED RATING SCALES (BARS) BARS combine best features of narrative, critical incidents, and quantified scales Generate   critical incidents Develop   performance dimensions Reallocate incidents Scale the incidents Develop a final instrument
BARS for grocery clerks by critical incidents in 8 areas Knowledge and judgment Conscientiousness Skill in human relations  Skill in operation of register 1   Extrmly Poor |Poor |Avg   Skill in bagging  Ability of checkout work Skill in monetary transactions Observational ability Good |Extremely Good   9
APPRAISAL BY OBJECTIVES Set the organization’s goals Set the departmental goals Discuss developmental goals Define expected results Performance reviews Provide feedback
METHODS OF APPRAISAL (Contd.) MULTI – PERSON COMPARISON Paired Comparison Forced Distribution Merck began using this rating method for certain employees when it found other methods resulted in 80% of employees rated a 4 or higher on a 5 point scale. 360 DEGREE APPRAISAL Very Existence Helps Anonymous?
METHODS OF APPRAISAL (Cotd.) ELCTRONIC MEASUREMENT Surveillance? 30 Million in 1996 Spend $ 1 b AMERICAN CIVIL LIBERTIES UNION
BALANCED SCORECARD (Kaplan & Norton)
BIASES SINGLE CRITERION LENIENCY ERROR “ If you are incompetent they would say “perhaps needs some training.” you need an eye, I mean you have to be sort of criminologist, because you’ll find that very little negative stuff is said…” HALO ERROR SIMILARITY ERROR LOW DIFFERENTIATION Central Tendency
BIASES (Contd.) FORCING INFORMATION TO MATCH CRITERIA  DEFENSIVE REACTION “ It is one of the most difficult things we ask line managers to do. You have to continue to work with these people, count on them. They are critical to your success. And all of a sudden you are the judge .” LATE FEEDBACK PERSONAL BIASES
OVERCOMING PROBLEMS USE MULTIPLE CRITERIA DE-EMPHASISE TRAITS USE MULTIPLE EVALUATORS EVALUATE SELECTIVELY FOCUS ON TRAINING NOT REWARDS
OVERCOMING PROBLEMS (Contd.) FROM FITTING IN A JOB TO CONTINUOUS LEARNING TRAIN APPRAISER DIARY KEEPING Keep a diary of critical incidents GRIEVANCE HANDLING SYSTEM CAREFUL RECORD KEEPING
OVERCOMING PROBLEMS (Contd.) INVOLVE USERS IN DESIGNING THE SYSTEM REWARD FOR PERFORMANCE APPRAISAL PERFORMANCE INTERVIEW Handle Sensitively Open/ direct/ objective
Fed Ex  Appraisal Example Uses a three-phase upward feedback system - Survey Feedback Action (SFA) Yearly anonymous HR standard survey Feedback session between manager and group Action plan phase What is the concern?  What is your analysis?  What is the cause?  What should be done?
WHAT HAPPENS TO THE TEAM WORK? WHO IS APPRAISED?
An Activity in Performance Appraisal ADDRESSING SALLY’S ERRORS IN JUDGEMENT You are a senior student nurse and this is your sixth week of MS + Leadership Clinical Focus.  Your CI assigns two students to work together in caring got gour to six patients.  The students alternate fulfilling leader and follower roles and providing total patient care. This is the second full day that you have worked as a team with Sally Kayumanggi.
Last week, when you were assigned with Sally, she was the leader and made numerous errors in judgment.  She got a patient up who was on strict bed rest.  She made an IV Medication error giving a medication to the wrong patient.  She gave Nubain too soon because she forgot to record the time in the therapeutic sheet and she frequently did not seem to know what was wrong with her patients.
Today you have been the leader and have observed her contaminate a dressing and forget to observe the 5 basic rights twice when she was giving medications.  When you asked her about checking placement of the NGT, she did not know how to perform this skill. You have heard some of the other students complain about Sally.  What is your obligation to your patients, your fellow students, the Clinical Agency (Hospital) and your instructor?  Outline what you would do.  Give rationale for your decisions.
Quality Assurance Quality assurance is a wide ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. QA is the  heart and soul  of quality control QA = QC + GMP
The System of Quality Assurance Managerial responsibilities are clearly specified in job description Arrangements are made for the manufacture, supply  and use of the correct starting and packaging materials. All necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out.
The System of Quality Assurance The finished products is correctly processed and checked according to the defined procedures. Pharmaceutical products are not sold or supplied before the authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products
The System of Quality Assurance Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed and subsequently handled so that quality is maintained throughout their shelf-life. There is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system
The System of Quality Assurance Deviation are reported, investigated and recorded There is a system for approving changes that may have an impact on product quality Regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement.
Quality Assurance-Highlights Quality assurance is independence of manufacturing In process quality is checked during manufacturing Validation of facilities, equipments, process, products and cleaning as per master plan
Quality Assurance-Highlights Complaint handling Storage of quality record and control samples Stability studies Registration of documents
Activities of Quality Assurance Dept. 1.Technology transfer 2. Validation 3. Documentation 4. Assuring quality of products 5. Quality improvement plans
1. Technology Transfer Receipt of product design documents from research centre Distribution of documents received from research centre Checking and approval of documents generated based on research centre documents i.e. batch manufacturing record Scale-up and validation of product
2. Validation Preparation of validation plans for facility, equipments/process including cleaning Approval of protocol for validation of facility/equipment/product/process Team member for execution of validation of facility/equipment/product/process
3. Documentation Control Controlled distribution and archiving of documents Control of changes made by proper change control procedure Approval of all documents
4. Assuring Quality of Products cGMP training SOP compliance Audit of facility for compliance Line clearance In-process counter checks Critical sampling  Record verification Release of batch for marketing Investigation of market complaints
5. Quality Improvement Plans Feedback received from the compliance team Proposals for corrective and preventive actions Annual Products review Trend analysis of various quality parameters for products, environment and water
Flow Chart – RM/PM Inspection
Flow Chart-Finished Product Inspections
Flow Chart- In Process Check
 
 
THANK YOU E-mail: bknanjwade@yahoo.co.in
 
 
 
 
 
 

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Controlling 2

  • 1. CONTROLLING Part Two Nelia B. Perez RN, MSN College of Nursing Northeastern College Santiago City 3311
  • 2. Establishment of Objectives and Methods for Measuring Performance Task analysis - actions and procedures are inspected - written guides, schedules, rules, records, and budgets. - uses tools as time studies and checklist Quality Control - Activities and techniques employed to achieve and maintain the quality of a product, service or process. - includes a monitoring activity of but is also concerned with finding and eliminating causes of problems so that the requirements of the customer are continually met.
  • 3. Measuring actual Performance An ongoing, repetitive process with the actual frequency dependent on the type of activity being measured.
  • 4. PERFORMANCE MATCHES STANDARDS & OBJECTIVES PERFORMANCE IS CONTRARY TO STANDARDS & OBJECTIVES SET
  • 5. RESPONSIBILITY OF HEAD / SENIOR NURSE
  • 7. I’m always ready to learn, although I do not always like being taught. Winston Churchill
  • 9. What Do Managers Like Least? • Firing an employee • Performance appraisals
  • 10. Managers take a big share of the credit for success. We also have to take the blame for failures – including those of our staff.
  • 11. You play a major role with those you supervise. Your staff wants to know your opinion of their work. Talk to them regularly as part of your ongoing coaching.
  • 13. Setting Standards • Everyone doing a job should know what he/she is expected to do. • Standards must be attainable. • There must be a point against which performance can be measured.
  • 14. Setting Standards • Involve your staff in setting standards. • Self-evaluation will then become automatic. • Corrective action can be taken immediately. • You provide the encouragement to stay on target.
  • 16. Action Steps Working with Human Resources: • Review your department’s job descriptions. • If needed, add a list of standards to be met. • Design an evaluation system – how will you measure performance?
  • 17. There’s More! Part 2: Structuring the performance review • Review and preparation • Putting the employee (and you!) at ease • Giving feedback
  • 18. There’s More! Part 3: Giving negative feedback & setting goals • Structure for giving negative feedback • Reviewing last year’s goals/setting new goals • Career development plans • What NOT to do • Ending on a positive note
  • 20. PURPOSE COMPENSATION CAREER PLANNING FEEDBACK TRAINING HUMAN RESOURCE PLANNING EXIT RESEARCH MOTIVATION IS THE OVERALL PURPOSE
  • 21. WHAT IS APPRAISED? INDIVIDUAL TASK OUTCOMES BEHAVIOUR TRAITS COLLECTIVE OUTCOMES COLLECTIVE PROCESSES WHAT IS EXPECTED OF THE PERSON?
  • 22. WHO APPRAISES? IMMEDIATE SUPERIOR HIGHER LEVELS PEERS SELF IMMEDIATE SUBORDINATES COMMITTEE
  • 23. METHODS OF APPRAISAL WRITTEN ESSAYS (ACR) Final appraisals are frequently in a written narrative form Supervisor rates employee’s: Performance factor or skill Give examples & an improvement plan Explains good & bad performance areas Subjective CRITICAL INCIDENTS
  • 24. GRAPHICAL RATING SCALES Define the Traits Potential Appraisal
  • 25. BEHAVIOURALLY ANCHORED RATING SCALES (BARS) BARS combine best features of narrative, critical incidents, and quantified scales Generate critical incidents Develop performance dimensions Reallocate incidents Scale the incidents Develop a final instrument
  • 26. BARS for grocery clerks by critical incidents in 8 areas Knowledge and judgment Conscientiousness Skill in human relations Skill in operation of register 1 Extrmly Poor |Poor |Avg Skill in bagging Ability of checkout work Skill in monetary transactions Observational ability Good |Extremely Good 9
  • 27. APPRAISAL BY OBJECTIVES Set the organization’s goals Set the departmental goals Discuss developmental goals Define expected results Performance reviews Provide feedback
  • 28. METHODS OF APPRAISAL (Contd.) MULTI – PERSON COMPARISON Paired Comparison Forced Distribution Merck began using this rating method for certain employees when it found other methods resulted in 80% of employees rated a 4 or higher on a 5 point scale. 360 DEGREE APPRAISAL Very Existence Helps Anonymous?
  • 29. METHODS OF APPRAISAL (Cotd.) ELCTRONIC MEASUREMENT Surveillance? 30 Million in 1996 Spend $ 1 b AMERICAN CIVIL LIBERTIES UNION
  • 31. BIASES SINGLE CRITERION LENIENCY ERROR “ If you are incompetent they would say “perhaps needs some training.” you need an eye, I mean you have to be sort of criminologist, because you’ll find that very little negative stuff is said…” HALO ERROR SIMILARITY ERROR LOW DIFFERENTIATION Central Tendency
  • 32. BIASES (Contd.) FORCING INFORMATION TO MATCH CRITERIA DEFENSIVE REACTION “ It is one of the most difficult things we ask line managers to do. You have to continue to work with these people, count on them. They are critical to your success. And all of a sudden you are the judge .” LATE FEEDBACK PERSONAL BIASES
  • 33. OVERCOMING PROBLEMS USE MULTIPLE CRITERIA DE-EMPHASISE TRAITS USE MULTIPLE EVALUATORS EVALUATE SELECTIVELY FOCUS ON TRAINING NOT REWARDS
  • 34. OVERCOMING PROBLEMS (Contd.) FROM FITTING IN A JOB TO CONTINUOUS LEARNING TRAIN APPRAISER DIARY KEEPING Keep a diary of critical incidents GRIEVANCE HANDLING SYSTEM CAREFUL RECORD KEEPING
  • 35. OVERCOMING PROBLEMS (Contd.) INVOLVE USERS IN DESIGNING THE SYSTEM REWARD FOR PERFORMANCE APPRAISAL PERFORMANCE INTERVIEW Handle Sensitively Open/ direct/ objective
  • 36. Fed Ex Appraisal Example Uses a three-phase upward feedback system - Survey Feedback Action (SFA) Yearly anonymous HR standard survey Feedback session between manager and group Action plan phase What is the concern? What is your analysis? What is the cause? What should be done?
  • 37. WHAT HAPPENS TO THE TEAM WORK? WHO IS APPRAISED?
  • 38. An Activity in Performance Appraisal ADDRESSING SALLY’S ERRORS IN JUDGEMENT You are a senior student nurse and this is your sixth week of MS + Leadership Clinical Focus. Your CI assigns two students to work together in caring got gour to six patients. The students alternate fulfilling leader and follower roles and providing total patient care. This is the second full day that you have worked as a team with Sally Kayumanggi.
  • 39. Last week, when you were assigned with Sally, she was the leader and made numerous errors in judgment. She got a patient up who was on strict bed rest. She made an IV Medication error giving a medication to the wrong patient. She gave Nubain too soon because she forgot to record the time in the therapeutic sheet and she frequently did not seem to know what was wrong with her patients.
  • 40. Today you have been the leader and have observed her contaminate a dressing and forget to observe the 5 basic rights twice when she was giving medications. When you asked her about checking placement of the NGT, she did not know how to perform this skill. You have heard some of the other students complain about Sally. What is your obligation to your patients, your fellow students, the Clinical Agency (Hospital) and your instructor? Outline what you would do. Give rationale for your decisions.
  • 41. Quality Assurance Quality assurance is a wide ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. QA is the heart and soul of quality control QA = QC + GMP
  • 42. The System of Quality Assurance Managerial responsibilities are clearly specified in job description Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials. All necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out.
  • 43. The System of Quality Assurance The finished products is correctly processed and checked according to the defined procedures. Pharmaceutical products are not sold or supplied before the authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products
  • 44. The System of Quality Assurance Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed and subsequently handled so that quality is maintained throughout their shelf-life. There is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system
  • 45. The System of Quality Assurance Deviation are reported, investigated and recorded There is a system for approving changes that may have an impact on product quality Regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement.
  • 46. Quality Assurance-Highlights Quality assurance is independence of manufacturing In process quality is checked during manufacturing Validation of facilities, equipments, process, products and cleaning as per master plan
  • 47. Quality Assurance-Highlights Complaint handling Storage of quality record and control samples Stability studies Registration of documents
  • 48. Activities of Quality Assurance Dept. 1.Technology transfer 2. Validation 3. Documentation 4. Assuring quality of products 5. Quality improvement plans
  • 49. 1. Technology Transfer Receipt of product design documents from research centre Distribution of documents received from research centre Checking and approval of documents generated based on research centre documents i.e. batch manufacturing record Scale-up and validation of product
  • 50. 2. Validation Preparation of validation plans for facility, equipments/process including cleaning Approval of protocol for validation of facility/equipment/product/process Team member for execution of validation of facility/equipment/product/process
  • 51. 3. Documentation Control Controlled distribution and archiving of documents Control of changes made by proper change control procedure Approval of all documents
  • 52. 4. Assuring Quality of Products cGMP training SOP compliance Audit of facility for compliance Line clearance In-process counter checks Critical sampling Record verification Release of batch for marketing Investigation of market complaints
  • 53. 5. Quality Improvement Plans Feedback received from the compliance team Proposals for corrective and preventive actions Annual Products review Trend analysis of various quality parameters for products, environment and water
  • 54. Flow Chart – RM/PM Inspection
  • 56. Flow Chart- In Process Check
  • 57.  
  • 58.  
  • 59. THANK YOU E-mail: bknanjwade@yahoo.co.in
  • 60.  
  • 61.  
  • 62.  
  • 63.  
  • 64.  
  • 65.