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Implementing Standard Operating Procedures, Guidelines …

PharmalinkA Publication of Ecumenical Pharmaceutical Network Implementing Standard Operating procedures , Guidelines and StandardsVol 13 : Issue 1 - October 2013 Strategies for quality servicesPharmalinkiPharmalink1 Editorial I have not failed. I ve just found 10,000 ways that won t work, Thomas Alva Edison. Whether you work in a hospital, a drug supply organization or production unit, you have tools, materials, and last but not least colleagues, customers, people to interact with. To get things right is always a challenge. How do we design our processes, how do we organise ourselves? Who is responsible for what?Get started! Joint Medical Store, Uganda, shares experiences regarding the implementation of an SOP programme under the quality management system, which culminated into acquisition of ISO certification in 2011.

Pharmalink A Publication of Ecumenical Pharmaceutical Network Implementing Standard Operating Procedures, Guidelines and Standards Vol 13 : Issue 1 - October 2013

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1 PharmalinkA Publication of Ecumenical Pharmaceutical Network Implementing Standard Operating procedures , Guidelines and StandardsVol 13 : Issue 1 - October 2013 Strategies for quality servicesPharmalinkiPharmalink1 Editorial I have not failed. I ve just found 10,000 ways that won t work, Thomas Alva Edison. Whether you work in a hospital, a drug supply organization or production unit, you have tools, materials, and last but not least colleagues, customers, people to interact with. To get things right is always a challenge. How do we design our processes, how do we organise ourselves? Who is responsible for what?Get started! Joint Medical Store, Uganda, shares experiences regarding the implementation of an SOP programme under the quality management system, which culminated into acquisition of ISO certification in 2011.

2 The article provides insight into the steps taken in the process of developing SOPs, which may be of interest to organizations who find themselves at the base of this mountain. Our eyes are very important for recognising our surroundings. They are also very sensitive if we expose them to dust or spills and eyedrops if contaminated. Read the second article and see how the Kabgayi Eye Unit, a Rwandan manufacturer of eye drops has improved the quality of eye drops manufactured in its department through SOPs. From the other side of the ocean, i+solutions, Netherlands, shares its insight on how well structured processes and quality policies have a direct effect on patient care. They emphasise the need to not only look at the processes but also the people and products involved. An example to learn from is their ISO 9001-2008 certification.

3 The article by a Diocesan health coordinator in Uganda pinpoints another important aspect: tools for quality management can be very relevant but staff training and staff involvement are crucial, especially in the case of high staff turnover. Finally, we learn of the leaps and bounds in progress made by Gertrude s Children s Hospital since 2008, when they started developing Guidelines and policies for extemporaneous compounding. The quality of extemporaneous preparations has since greatly improved, assuring patients of the safety and potency of their products. It is up to us to organise ourselves and our processes to improve quality. It will not just happen. The tasks to implement quality management systems appear huge and sometimes overwhelming. The examples in this edition of Pharmalink give proof that the efforts are worth to be WiegandAbout Ecumenical Pharmaceutical Network (EPN)Ecumenical Pharmaceutical Network (EPN) is an independent, not-for-profit, Christian organization whose mission is to support churches and church health systems provide and promote just and compassionate quality pharmaceutical services for all.

4 In addition, the work of EPN is aimed at working towards services that allow no discrimination and guarantee equal access to all. About the cover imageThe image depicts health professionals discussing a Standard Operating procedure for procurement. The image was used in the EPN Guidelines for effective and efficient pharmaceutical this issue1. The success of SOPs at JMS2. Implementation of Standard Operating procedures in Kabgayi Eye Unit: local manufacturing of eye drops3. Total Quality: processes, people, products4. Relevancy of tools for quality management in Kampala Diocesan Health Units - Uganda5. standards -based Pharmacy Practice at Gertrude s Children s Hospital - Enhanced Extemporaneous Compounding6. References and resourcesEditorial CommitteeDr Andreas Wiegand, Elisabeth GoffinTranslation, layout and designElisabeth GoffinLetters to the editorInquiries or comments about this edition of Pharmalink should be directed to: editor also welcomes author s initiatives for future expressed in this edition of Pharmalink are those of the authors and do not necessarily reflect the views of Ecumenical Pharmaceutical success of SOPs at JMSE mmanuel Higenyi14811 1315A Standard Operating Procedure (SOP) is a step by step guide having the force of a direc-tive, outlining the sequence of steps required to accomplish an activity and clearly indicating the start and finish points.

5 Where necessary, SOPs may indicate persons responsible for specific tasks, requisite resources and references. Much as this definition appears rather straightforward, there is usually confusion regarding the differ-ence between SOPs and related management tools such as policies, rules, Guidelines , proto-cols and job aids or written instructions. The International Conference on Harmonisation1 (ICH) defines SOPs as detailed, written instructions to achieve uniformity of the performance of a specific function .A policy is a plan or course of action made by an institution or body, in-tended to influence and determine decisions, ac-tions related issues or a guiding principle or course of action adopted toward an objective or objectives. A protocol is a code of correct con-duct; a rule on how an activity should be per-formed (in written or unwritten form).

6 A rule is a prescribed guide for conduct or action. It may be defined as a principle set up by an authority that prescribes or directs an action. A rule differs from a SOP in that it neither refers to a process nor prescribes steps for carrying out an action. A regulation is a rule or order prescribed by an authority to regulate conduct. A guideline is a statement by which to determine a course of action. This is closely related to a SOP but does not prescribe steps. A job aid or work instruc-To realize business excellence, Joint Medical Store started im-plementing the quality man-agement system five years ago, a process that culminated into acquisition of ISO (International Organization for Standardization) certification in 2011. tion describes step by step what you should do to perform a procedure or task.

7 These usually work hand in hand with of SOPsWhen developed and implemented successfully, SOPs have a number of compelling benefits such as: Minimising process variability (person-to-per-son) thus promoting process consistency Minimising result variability thus promoting result consistency and reproducibility Sustained return on in-vestment due to reduced process errors Performing continual quality improvement Facilitating training for new employees Investigating discrepan-cies in resultsAlthough SOPs are widely acknowledged and high-ly regarded as important business tools, in real practice, the implementation of a SOP pro-gramme is daunted with several challenges that limit realization of the maximum benefit en-dowed in these tools. There is diversity among organizations and institutions regarding expe-riences with development and use of SOPs.

8 Differences in organizational culture, type of in-dustry and employee mindset may be responsi-ble for a large part of the JMS experience with SOPsJoint Medical Store (JMS) is a supply chain or-ganization in Uganda whose prime engagement is procurement, warehousing and distribution of To realize business excellence, Joint Medical Store started im-plementing the quality man-agement system five years ago, a process that culminated into acquisition of ISO (International Organization for Standardization) certification in 2011. To realize business excellence, Joint Medical Store started im-plementing the quality man-agement system five years ago, a process that culminated into acquisition of ISO (International Organization for Standardization) certification in 2011. Pharmalink2 Pharmalink3medicines and other supplies used in delivery of health care.

9 This core responsibility is blended with provision of technical assistance to health-care institutions and service realize business excellence, Joint Medical Store started Implementing the quality manage-ment system five years ago, a process that cul-minated into acquisition of ISO (International Organization for Standardization)2 certification in 2011. The process was very challenging with many learning points but each milestone was a major achievement. The first step was to carry out a comprehen-sive business review with a view of mapping the business processes. In this exercise, non value adding activities were identified and eliminated while the value adding activities were realigned. This step, much as it may appear simple, was one of the most challenging when initiating a quality management system (QMS).

10 This is because for the QMS to be successful, it should be founded on processes that provide value to all stakehold-ers, including customers. To facilitate QMS imple-mentation, a document management system was established to guide creation, review and filing of documents including Standard Operating second step was to review and validate the existing SOPs for specific processes. The SOPs were checked for relevance to the new proc-ess map. This step was quite interesting because initially the SOPs were developed on a predomi-nantly function-based organizational structure. The real challenge here was moving beyond organization silos (departments or units oper-ating in isolation without regard of what hap-pens in other departments or units) to develop SOPs that cut across departments and functions.


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