This document outlines an efficient process for contract review to ensure effective compliance. It recommends identifying subject matter experts, defining a document management system requiring 7 documents for every file, and regular follow up meetings. The goals of contract review are confirmation, expectations, and risk analysis. An efficient review process includes identifying experts, tracking documents, and weekly meetings. Effective compliance has two aspects - following the internal review process and complying with contract terms. It suggests implementing a review process, document management, metrics, training, and internal audits.
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For the importer of record, compliance means the complete
and accurate recording of all internal processes through
books and records, from procurement to payment (P2P).
Compliance means following Customs laws and regulations
on both imports and exports. Good compliance facilitates
the movement of trade at the border. For the government,
it ensures security through quality trade data, the proper
collection of duties and taxes, the proper application of
preferential duty tariffs, and the protection of target industries
(e.g., textiles). For the importer, it prevents supply chain
bottlenecks, costly production downtime, and errors that can
result in expensive penalties.
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You already know internal quality audits are required by both FDA 21 CFR Part 820 and ISO 13485.
You also probably already know they are a big hassle to conduct.
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Why?
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- How to properly report the findings of your internal quality audit
- How to concisely document non-conformances
- How to determine what needs corrective actions and how to follow up on them
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While process mining is perceived by many as a very cool technology, yet companies are not willing to embrace it as warmly and quickly as expected. Managers still expect more convincing and significant added value. Another issue might be with offering process mining technology as somewhat detached solution and not taking into account BI solutions, which might already exist in a company.
The attached presentation proposes a solution which is based on an integration of ERP, BI and process mining technologies.
The technologies used enable a quick, easy and low cost “jumpstart” in order to increase ‘process minding’ in a company. Hope you find it useful!
Auditing Accounting Estimates & Using the Work of SpecialistsJeffrey Johanns
If you haven’t had time to study the new PCAOB proposals on auditing estimates and using specialists, check out my in-depth Slideshare analysis of the requirements and potential issues.
For the importer of record, compliance means the complete
and accurate recording of all internal processes through
books and records, from procurement to payment (P2P).
Compliance means following Customs laws and regulations
on both imports and exports. Good compliance facilitates
the movement of trade at the border. For the government,
it ensures security through quality trade data, the proper
collection of duties and taxes, the proper application of
preferential duty tariffs, and the protection of target industries
(e.g., textiles). For the importer, it prevents supply chain
bottlenecks, costly production downtime, and errors that can
result in expensive penalties.
Your project selected_for_audit_sip18_project_auditorsJoy Gumz
Project audit: Presentation about auditing project management with Case study view. Presentation given at PMI EMEA Congress 2006 by Project Auditors LLC.
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You already know internal quality audits are required by both FDA 21 CFR Part 820 and ISO 13485.
You also probably already know they are a big hassle to conduct.
What you might not know is that they are one of the most powerful weapons at your disposal for preventing 483's and observations.
Why?
Because they are one of the most effective and efficient ways to make sure you and your team are always prepared if FDA or NB decided to show up unexpectedly.
So how do you “establish” the right procedures? How do you ensure your auditor is competent and properly qualified? And what do you do if you find non-conformances?
View this presentation by our guest Kyle Rose, President at Rook Quality Systems, where you will find the answers to all those questions and more.
Specifically, you will learn:
- How to conduct an effective internal quality audit based on process identification, sampling and questioning
- How to plan a internal quality audit and develop an audit schedule
- How to find and use competent and qualified auditors
- Why certain auditors shouldn’t audit certain areas
- How to properly report the findings of your internal quality audit
- How to concisely document non-conformances
- How to determine what needs corrective actions and how to follow up on them
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4. Why is contract review important?
• What can go wrong in a contract?
• Can you identify that up front?
• How do some of you review contracts
today?
4
10. 2.0 Keys to an Efficient Process
1. Identify subject matter experts (SME)
(department managers?)
2. Define a system for tracking documents,
revisions, reviews, and approvals (Document
management, SharePoint, ERP)
3. Regular meetings and follow-up (weekly
huddle)
10
11. 2.1 Subject Matter Experts (SME)
• T&C - payment terms, warranty, insurance,
termination, liquidated damages, etc.
• Quality - quality requirements or
certifications
• Spec - can we build the product and meet
the spec?
• Exports - product jurisdiction, classification,
and licensing requirements
11
12. 2.1Subject Matter Experts (SME)
• Materials - do we have the supplies and
can we get them in time?
• Software - do we have updated test
software?
• Planning - is there capacity to build the
product?
• Program Management - are there any
SOW issues?
12
13. 3.0 Documents for EVERY file
1. Signed Contract or Purchase Order
– Including a record of negotiations, with
references to other documents
1. Terms & Conditions
– including any Quality clauses
1. Non-Disclosure Agreement (NDA/PIA)
2. Specification and/or Drawing
– what is being built, designed, or serviced
13
14. 3.0 Documents for EVERY file
5. Statement of Work
– how and where the work is to be performed
5. Export Review
– including restricted party screening and product
or service jurisdiction and classification
5. Quote Package
– including original RFP/Q and Basis of Estimate
14
15. 4.0 Effective Compliance
There are two aspects of compliance:
1. Compliance to the review process and your
internal procedures
2. Compliance to the contract
15
16. 4.1 Compliance to the Process
1. Implement a review process
– defined process, released procedure
1. Define a document management system
2. Reporting and Metrics for TAT(turn around
time)
3. Training
4. Internal audit
– could be part of QMS/AS internal audit
16
17. 4.1.1 Review Process
• Hold a Kaizen event
• Have a defined process and written
procedure
17
18. 4.1.2 Document Management
• Seven documents for every file
• Defined naming and filing system
• Document retention requirements
18
19. 4.1.3 Reporting & Metrics
• Define metrics
• Provide reports and feedback
19
20. 4.1.4 Training
• Provide training as a result of Kaizen and
updated process
• Train new employees
• Refresher training for those not actively
involved in the process
20
21. 4.1.5 Internal Audit
• Incorporate into your QMS/AS audit
• Have a sister company audit
• Have another department audit
21
23. Review & Connect
3 keys to implementing an efficient contract review
process:
1.Identify subject matter experts (SME).
2.Document management
– 7 Documents for EVERY File
1.Follow-up
– 5 Steps for Effective Compliance
23
24. Questions
Robert E. Jones
CFCM, CCCM
Contracts Manager, Pole/Zero Corporation
rjones@leftbrainpro.com
(513) 728-1163
www.linkedin.com/in/rjones330
www.leftbrainpro.com
24
Editor's Notes
We could talk about T&C, flow-down clauses, etc. That’s a whole other seminar (or 2, or 3). This presentation is focused on the review process itself and compliance.
What can go wrong? What are we trying to prevent?
This is the “what” and “why” section of today’s presentation. We will get to the “who” and “how” sections later.
What else can we confirm with the customer?
What other expectations might be set? One of the main things I’ve learned in life is that all relationships are based on communication and expectations. And, when something goes wrong, it’s usually because of poor communication and missed expectations. How many times have you been disappointed about something, then later realized you never told the other person what you expected. In that case you failed to communicate and failed to make your expectations clear. Yes, there will be times when we communicate well, but expectations are still missed, and we will talk about that.
Have we identified and evaluated all of the risk? Do we have a template or matrix for tracking and ranking risk?
This is more of a Program Management tool, but it should be part of your overall contract review. You could even develop a tool just for the contract itself??
Who are your SMEs? What are the 7 documents? What are the 5 steps for compliance?