What are the Steps in Ensuring a Definition/Implementation of an Effective Procedure


Trusted Information Resource
counter question is what are the steps hindering effective definition/implementation of procedure (SOP, system)

Some of the places people/organizations are not aligned... hence ineffectiveness of system/procedures; & this is typical phenomenon in pharma....(yes there are exceptions but then again they are pockets of bright ilghts... not quantified...not qualified... )

What i have noticed is that people tend to see what is minimum requirement...and that is it...!!!

its even worse in case of implementation., most of times, what people tend to focus is on 'mere document'; not effectiveness of it. (this is especially true for new procedures )

+ for old systems...whole emphasis seems to be demonstrating "compliance"... often deemed as having a documented evidence. (focus of compliance is of-late shifting to improvements thanks to FDA focus on trending & CAPA)
Elsmar Forum Sponsor


Re: What are the Steps in Ensuring a Definition/Implementation of an Effective Proced

I believe that the root of most of the issues that come up have to do with buy-in. Unless you can convince everyone that having a well-documented, accurate set of procedures and work instructions will benefit them, the roadblocks are more likely to remain in place.

I think the common thought is that the documents are there to appease auditors and show that your system conforms to a standard’s requirements. Experienced employees that have been using systems for a long time are less likely to refer to their procedures and work instructions (in my experience). I think the trick is showing that they have to potential to do so much more.

One way to help this is to always use these documents for training. That should at least help to keep them up to date and accurate. Another tip came from a consultant we used. He always made a point of getting us to document our processes with enough detail that we could use it for problem solving or looking for root causes. The idea being that if something goes wrong, we can go back to the spot in the procedures or work instructions where things went wrong and see if it is a system deal. This can help with evaluating effectiveness. If problems keep pointing back to the same step in a procedure or work instruction, then something probably needs to be done about it.

Not quite sure if this is what you are looking for, but hope it helps!


Re: What are the Steps in Ensuring a Definition/Implementation of an Effective Proced

I agree the key requirement is buyin.

Before a document is created or before a review takes place the author needs to complete a stakeholder analysis to ensure that the author consults enough with all including the end users prior to release and also after release.


Trusted Information Resource
Re: What are the Steps in Ensuring a Definition/Implementation of an Effective Proced

exactly, the point is ""extent-commitment-objective/purpose"" of buy-in from stake holders is the point.

-->this has impact while ""defining"" the SOP, by curtailing the intent/extent of guidance; viz., more often than not; procedures only talks about ''plan - do "" (what and how and who and when) parts; ""check & verify ~~~ trend/improvement" are set(left) separately.... and removed from main procedure;

-->i mean, the baggage of delivery/operations kicks in while discussing the adequacy&completeness of a procedure; most frequent question is that this procedure is reviewed/approved auditor, why do we require any further/detailed step to be included in SOP?!!! further down the line, during implementation, miss-alignment gets reflected through amount of energy-time-focus spent on audit-preparations alone!!! we are happy spending that time/efforts over and over again ( i have personally seen numerous times within in a year and over period of year where organization numerous man-days on audit-preparations); but the same amount of enthu-energy isnot found when talking about improvements!!!;

--> btw, training and refresher courses are mandatory but they are just ceremonies(because if they were effective, we would have seen major strides&progress in the QMS of pharma systems as well!!!)

--> incidents/investigations would give you learning; but with above attitude how long could it be sustained is the question. (this is valid obs because, we keep seeing repeat incidents & complaints around!!! )

for good reason, (at-least pharma domain) the level of compliance is driven primarily(mainly) by regulators; ( even in other places, it seems to be seen as satisfaction/discretion of auditor/consultants!!! ) (of course that has also to do with other factors... viz., in auto industry some are more pioneers/conscious...few are meticulous etc.,; btw in pharma also there are pioneering work being done; but thats limited to certain forums; not so much into open domain) & flip side is the regulators are also not uniform there are somethings called as semi/less regulated markets and then there is are hypersensitive(yes there are ICH - PICs but still the individual regulators have differences); similar situations exist in other industries i guess.

*) i personally believe that, the QMS (atleast in pharma domain) has to shift its gear from definition (adequacy - meeting requirements) to --> driving efficiency/RCA-improvements; one of the best ways is to integrate the systems of "Check & Act" along with the system; and also integrate the related/relevant QMS. ( i think integrated-metrics is the way to do; and it gets little extensive, so need to take help of automation!!!)

**) as said earlier, regulators/consultants/auditors have onus of leading the change; (compliance-certification ---> improvement/RCAs/capabilities); This is especially crucial because of current state of affairs and role/influence they have in today's industry.(ref. above section)

***) One might think there are special initiatives 6-sigma; lean; even others target based projects cost-cuttings, inventories, marketing initiatives of customer satisfaction etc., the point is they are almost-always separately triggered-driven-completed. the reason for failure is mostly attributed to implementation team (either management or consultant !!!) (that is other major problem which is making the operations-functions to think that projects are more important (obviously they are focused & delivering improvements) and QMS is just another system hindering the real projects!!!) exactly, there is the opportunity to adopt QMS to drive the better rate of success;
Disadvantage of having these projects being handled separately; is that, they are not sustainable; and they are perceived to be primary focus and QMS gets secondary-minimal- alignment. Agreed that not all can be integrated with QMS; but then i would use same logic such as QMS is supposed to represent what is required; and also (pharma)industry have to come out of its shell which perceives that QMS is only cGMP and/or anything which matter with regulators alone!!!
Last edited:
Thread starter Similar threads Forum Replies Date
Z Steps to take before an MDSAP audit for Canada Canada Medical Device Regulations 2
S Sequence of ISO 9001:2015 Implementation Steps ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
Anonymous16-2 21 CFR Part 11 - Steps to take if we want to validate an electronic system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
N MDR review process by notified body - How many steps exist in the review process EU Medical Device Regulations 0
G Start and main steps of API Q1 Certification Process Various Other Specifications, Standards, and related Requirements 5
M FDA News Statement from USFDA on steps to strengthen the long-term safety oversight of the Essure device Medical Device and FDA Regulations and Standards News 0
J Steps when changing material for class 1 medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
N Process Flow diagram steps for inspection and packaging APQP and PPAP 4
leftoverture Control Plan - Multiple Process Steps FMEA and Control Plans 8
M FDA News FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program Other US Medical Device Regulations 0
M Medical Device News FDA - Transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices Other US Medical Device Regulations 0
C Sequence of Process Steps not Respected FMEA and Control Plans 3
Jane's What steps do you take to terminate a product which was licensed for sale in Canada Canada Medical Device Regulations 14
S Technical Steps to ISO 17025 Accreditation ISO 17025 related Discussions 1
G What are steps to be followed to get ISO 9001:2015 certified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K IEC 62304 - Compliance steps IEC 62304 - Medical Device Software Life Cycle Processes 5
Q Steps from ISO 9001 2008 to 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
rob73 New MDD (European Medical Device Regulations) next steps - 2016 EU Medical Device Regulations 1
M ISO 22000 Description of Process Steps and Control Measures Food Safety - ISO 22000, HACCP (21 CFR 120) 1
C Quality Assurance Manager ? Next Steps? Quality Manager and Management Related Issues 10
D Key steps to OHSAS 18001 Implementation Other ISO and International Standards and European Regulations 1
V Analysis of 'Value Added' System & Process Steps - Inspection Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
S What are the next steps after providing response to FDA 483 ? US Food and Drug Administration (FDA) 7
R Steps to Preserve ISO 9001 Certification during Corporate Acquisition? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q Moving steps from ISO 9001 to TL 9000 TL 9000 Telecommunications Standard and QuEST 4
D Steps to Complete Quality Control Plans and Work Instruction Manufacturing and Related Processes 4
C Must we identify steps taken to identify the Root Cause of a failure Nonconformance and Corrective Action 15
Sam Lazzara 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015) Other US Medical Device Regulations 45
G Further steps in Medical Devices Regulations in EU - Comments? EU Medical Device Regulations 11
S Calibration conducted to 3 steps only of the std instead of complete 5 steps General Measurement Device and Calibration Topics 4
J Eliminating Missing Steps In Manual Operations Human Factors and Ergonomics in Engineering 8
N Basic requirements and steps involved to get NADCAP Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Change in Career Path - Logical Steps Up and Ways Forward Career and Occupation Discussions 3
M The steps that my ISMS Internal Audit Report has to Contain IEC 27001 - Information Security Management Systems (ISMS) 3
S Depicting Communication Flow Gaps between Departments/Process Steps on a Process Map Process Maps, Process Mapping and Turtle Diagrams 1
J What are the steps to transfer TS 16949 certification or switch registrars? Registrars and Notified Bodies 4
B How many steps does a procedure have? Document Control Systems, Procedures, Forms and Templates 9
A PFMEA for an Assembly Process - Stuck in first steps FMEA and Control Plans 6
M System Building - What are the key steps? Quality Manager and Management Related Issues 2
H Process Development to Validation: What are the steps? Design and Development of Products and Processes 3
T Pilot's Checklist for Six Sigma - Steps to Consider when Initiating Projects Six Sigma 3
R Sales Order Process Flow Plan (Flow Chart) Steps help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
K Seeking guidance on Preliminary Steps to enable Hazard Analysis Food Safety - ISO 22000, HACCP (21 CFR 120) 1
bobdoering The CORRECT steps to implement an SPC chart Imported Legacy Blogs 16
E What are the general steps to distribute a medical device in U.S.? US Food and Drug Administration (FDA) 1
M How to Implement the QHSE Integrated Management System Easy Steps? Occupational Health & Safety Management Standards 1
A One of APQP Process Steps - OTS (Off Tool Sample) Approval APQP and PPAP 1
L Importing CSV (comma separated values) / Excel process steps into Visio diagram Excel .xls Spreadsheet Templates and Tools 2
B Green Initiative - Please help me in preparing Go Green Steps.... Sustainability, Green Initiatives and Ecology 6

Similar threads

Top Bottom